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ZENATANE
Overview
What is ZENATANE?
Isotretinoin USP, a retinoid, is available as Zenatane™ (isotretinoin capsules USP) in 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, ferric oxide red, ferric oxide yellow, hydrogenated vegetable oil (Type-I and Type-II), medium chain triglyceride, refined soybean oil and white wax. Gelatin capsules contain gelatin, glycerin, methyl paraben, propyl paraben, lake blend blue(LB-332) containing D&C Yellow No.10, FD&C Blue No.1 (for 10 mg), lake blend red (LB-1574) containing D&C Red No.27, D&C Red No.30 (for 20 mg), lake blend green (LB-333) containing D&C Yellow No.10, FD&C Blue No.1 (for 40 mg), lake blend white (TLB-1774) containing FD&C Blue No.2, titanium dioxide, opacode black S-1-27794 containing iron oxide black, N-butyl alcohol, propylene glycol, industrial methylene spirit and shellac (for 10 mg, 20 mg and 40 mg) and opacode black S-1-17823 containing iron oxide black, N-butyl alcohol, propylene glycol, ammonium hydroxide and shellac (for 30 mg).
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow or light orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform; sparingly soluble in alcohol, in isopropyl alcohol and in polyethylene glycon 400. The structural formula is:
Meets USP Test 5.
What does ZENATANE look like?
What are the available doses of ZENATANE?
Sorry No records found.
What should I talk to my health care provider before I take ZENATANE?
Sorry No records found
How should I use ZENATANE?
Severe Recalcitrant Nodular Acne
Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see ).
Zenatane should be administered with a meal (see ).
The recommended dosage range for Zenatane is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day,it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Zenatane with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Zenatane has not been established. Once daily dosing is recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Zenatane, even in low doses, has not been studied, and is not recommended. It is important that Zenatane be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Zenatane on bone loss is unknown (see , , and ).
Contraceptive measures must be followed for any subsequent course of therapy (see ).
Table 4 Zenatane Dosing by Body Weight (Based on Administration With Food)
*See : the recommended dosage range is 0.5 to 1 mg/kg/day.
What interacts with ZENATANE?
Pregnancy: Category X. See .
Allergic Reactions
What are the warnings of ZENATANE?
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Psychiatric Disorders
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Pseudotumor Cerebri
Zenatane use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, they should be told to discontinue Zenatane immediately and be referred to a neurologist for further diagnosis and care (see ).
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Serious Skin Reactions
There have been post-marketing reports of erythema multiforme and severe skin reactions [eg, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. These events may be serious and result in death, life-threatening events, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and discontinuation of Zenatane should be considered if warranted.
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Pancreatitis
Acute pancreatitis
In rare instances, fatal hemorrhagic pancreatitis has been reported.
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Lipids
Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Zenatane. Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Zenatane in clinical trials. In addition, approximately 15% developed a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels. In clinical trials, the effects on triglycerides, HDL, and cholesterol were reversible upon cessation of Zenatane therapy. Some patients have been able to reverse triglyceride elevation by reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing Zenatane .
Blood lipid determinations should be performed before Zenatane is given and then at intervals until the lipid response to Zenatane is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Zenatane therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Zenatane therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended (see ).
The cardiovascular consequences of hypertriglyceridemia associated with Zenatane are unknown.
Animal Studies: In rats given 8 or 32 mg/kg/day of isotretinoin (1.3 to 5.3 times the recommended clinical dose of 1.0 mg/kg/day after normalization for total body surface area) for 18 months or longer, the incidences of focal calcification, fibrosis and inflammation of the myocardium, calcification of coronary, pulmonary and mesenteric arteries, and metastatic calcification of the gastric mucosa were greater than in control rats of similar age. Focal endocardial and myocardial calcifications associated with calcification of the coronary arteries were observed in two dogs after approximately 6 to 7 months of treatment with isotretinoin at a dosage of 60 to 120 mg/kg/day (30 to 60 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area).
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Hearing Impairment
Impaired hearing has been reported in patients taking Zenatane; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanism(s) and causality for this event have not been established. Patients who experience tinnitus or hearing impairment should discontinue Zenatane treatment and be referred for specialized care for further evaluation (see ).
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Hepatotoxicity
Clinical hepatitis considered to be possibly or probably related to Zenatane therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Zenatane, the drug should be discontinued and the etiology further investigated.
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Inflammatory Bowel Disease
Zenatane has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Zenatane treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Zenatane immediately (see ).
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Skeletal
Bone Mineral Density
Effects of multiple courses of Zenatane on the developing musculoskeletal system are unknown. There is some evidence that long-term, high-dose, or multiple courses of therapy with isotretinoin have more of an effect than a single course of therapy on the musculoskeletal system. In an open-label clinical trial (N=217) of a single course of therapy with Zenatane for severe recalcitrant nodular acne, bone density measurements at several skeletal sites were not significantly decreased (lumbar spine change >-4% and total hip change >-5%) or were increased in the majority of patients. One patient had a decrease in lumbar spine bone mineral density >4% based on unadjusted data. Sixteen (7.9%) patients had decreases in lumbar spine bone mineral density >4%, and all the other patients (92%) did not have significant decreases or had increases (adjusted for body mass index). Nine patients (4.5%) had a decrease in total hip bone mineral density >5% based on unadjusted data. Twenty-one (10.6%) patients had decreases in total hip bone mineral density >5%, and all the other patients (89%) did not have significant decreases or had increases (adjusted for body mass index). Follow-up studies performed in eight of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in five patients at the lumbar spine, while the other three patients had lumbar spine bone density measurements below baseline values. Total hip bone mineral densities remained below baseline (range –1.6% to –7.6%) in five of eight patients (62.5%).
In a separate open-label extension study of ten patients, ages 13 to 18 years, who started a second course of Zenatane 4 months after the first course, two patients showed a decrease in mean lumbar spine bone mineral density up to 3.25% (see ).
Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been seen in the Zenatane population. While causality to Zenatane has not been established, an effect cannot be ruled out. Longer term effects have not been studied. It is important that Zenatane be given at the recommended doses for no longer than the recommended duration.
Hyperostosis
A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization with a mean dose of 2.24 mg/kg/day. Additionally, skeletal hyperostosis was noted in 6 of 8 patients in a prospective study of disorders of keratinization.Minimal skeletal hyperostosis and calcification of ligaments and tendons have also been observed by x-ray in prospective studies of nodular acne patients treated with a single course of therapy at recommended doses. The skeletal effects of multiple Zenatane treatment courses for acne are unknown.
In a clinical study of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, hyperostosis was not observed after 16 to 20 weeks of treatment with approximately 1 mg/kg/day of Zenatane given in two divided doses. Hyperostosis may require a longer time frame to appear. The clinical course and significance remain unknown.
Premature Epiphyseal Closure
There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Zenatane. The effect of multiple courses of Zenatane on epiphyseal closure is unknown.
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Vision Impairment
Visual problems should be carefully monitored. All Zenatane patients experiencing visual difficulties should discontinue Zenatane treatment and have an ophthalmological examination (see ).
Corneal Opacities
Corneal opacities have occurred in patients receiving Zenatane for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. The corneal opacities that have been observed in clinical trial patients treated with Zenatane have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug (see ).
Decreased Night Vision
Decreased night vision has been reported during Zenatane therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.
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What are the precautions of ZENATANE?
Zenatane must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Zenatane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Zenatane only from wholesalers registered with iPLEDGE.
iPLEDGE Program requirements for wholesalers, prescribers, and pharmacists are described below:
Wholesalers:
For the purpose of the iPLEDGE Program, the term wholesaler refers to wholesaler, distributor, and/or chain pharmacy distributor. To distribute Zenatane, wholesalers must be registered with iPLEDGE, and agree to meet all iPLEDGE requirements for wholesale distribution of isotretinoin products. Wholesalers must register with iPLEDGE by signing and returning the iPLEDGE wholesaler agreement that affirms they will comply with all iPLEDGE requirements for distribution of isotretinoin. These include:
-wholesalers registered in the iPLEDGE Program with prior written consent from the manufacturer or
-pharmacies licensed in the US and registered and activated in the iPLEDGE Program
Prescribers:
To prescribe isotretinoin, the prescriber must be registered and activated with the pregnancy risk management program iPLEDGE. Prescribers can register by signing and returning the completed registration form. Prescribers can only activate their registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
To prescribe isotretinoin, the prescriber must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to:
1) Register each patient in the iPLEDGE Program.
2) Confirm monthly that each patient has received counseling and education.
3) For females of reproductive potential:
Isotretinoin must only be prescribed to female patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test.
Isotretinoin must only be dispensed by a pharmacy registered and activated with the pregnancy risk management program iPLEDGE and only when the registered patient meets all the requirements of the iPLEDGE Program. Meeting the requirements for a female of reproductive potential signifies that she:
-For patients with regular menstrual cycles, the second pregnancy test should be done during the first 5 days of the menstrual period immediately preceding the beginning of isotretinoin therapy and after the patient has used two forms of contraception for one month.
-For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done immediately preceding the beginning of isotretinoin therapy and after the patient has used two forms of contraception for one month.
If the patient has unprotected heterosexual intercourse at any time 1 month before, during, or 1 month after therapy, she must:
1. Stop taking Zenatane immediately, if on therapy
2. Have a pregnancy test at least 19 days after the last act of unprotected heterosexual intercourse
3. Start using 2 forms of effective contraception simultaneously again for 1 month before resuming Zenatane therapy
4. Have a second pregnancy test after using 2 forms of effective contraception for 1 month as described above depending on whether she has regular menses or not.
Effective forms of contraception include both primary and secondary forms of contraception:
Any birth control method can fail. There have been reports of pregnancy from female patients who have used oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products; these pregnancies occurred while these patients were taking Zenatane. These reports are more frequent for female patients who use only a single method of contraception. Therefore, it is critically important that females of reproductive potential use two effective forms of contraception simultaneously. Patients must receive written warnings about the rates of possible contraception failure (included in patient education kits).
Using two forms of contraception simultaneously substantially reduces the chances that a female will become pregnant over the risk of pregnancy with either form alone. A drug interaction that decreases effectiveness of hormonal contraceptives has not been entirely ruled out for Zenatane (see ). Although hormonal contraceptives are highly effective, prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort.
If a pregnancy does occur during Zenatane treatment, Zenatane must be discontinued immediately. The patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure during or one month after Zenatane therapy must be reported immediately to the FDA via the MedWatch number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet ().
All Patients
Isotretinoin is contraindicated in female patients who are pregnant. To receive isotretinoin all patients must meet all of the following conditions:
Females of Reproductive Potential
Isotretinoin is contraindicated in female patients who are pregnant. In addition to the requirements for all patients described above, females of reproductive potential must meet the following conditions:
Pharmacists:
To dispense isotretinoin, pharmacies must be registered and activated with the pregnancy risk management program iPLEDGE.
The Responsible Site Pharmacist must register the pharmacy by signing and returning the completed registration form. After registration, the Responsible Site Pharmacist can only activate the pharmacy registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
To dispense isotretinoin, the pharmacist must:
1) be trained by the Responsible Site Pharmacist concerning the iPLEDGE Program requirements.
2) obtain authorization from the iPLEDGE Program via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) for every isotretinoin prescription. Authorization signifies that the patient has met all program requirements and is qualified to receive Zenatane.
3) write the Risk Management Authorization (RMA) number on the prescription.
Zenatane must only be dispensed:
A Zenatane Medication Guide must be given to the patient each time Zenatane is dispensed, as required by law. This Zenatane Medication Guide is an important part of the risk management program for the patients.
Zenatane must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE Program. Only FDA-approved Zenatane products must be distributed, prescribed, dispensed, and used. Patients must obtain Zenatane™ prescriptions only at US licensed pharmacies.
A description of the iPLEDGE Program educational materials available with iPLEDGE is provided below. The main goal of these educational materials is to explain the iPLEDGE Program requirements and to reinforce the educational messages.
1) isotretinoin teratogenic potential, information on pregnancy testing, and the method to complete a qualified Zenatane prescription.
2) specific information about effective contraception, the limitations of contraceptive methods, behaviors associated with an increased risk of contraceptive failure and pregnancy and the methods to evaluate pregnancy risk.
3) isotretinoin teratogenic potential and the method to obtain authorization to dispense an isotretinoin prescription.
4) The iPLEDGE Program is a systematic approach to comprehensive patient education about their responsibilities and includes education for contraception compliance and reinforcement of educational messages. The iPLEDGE Program includes information on the risks and benefits of Zenatane which is linked to the Medication Guide dispensed by pharmacists with each isotretinoin prescription.
5) Females of non-reproductive potential and male patients, and females of reproductive potential are provided with separate booklets. Each booklet contains information on isotretinoin therapy including precautions and warnings, a Patient Information/Informed Consent (for all patients) form, and a toll-free line which provides Zenatane information in two languages.
6) The booklet for females of non-reproductive potential and male patients, also includes information about male reproduction and a warning not to share Zenatane with others or to donate blood during isotretinoin therapy and for one month following discontinuation of isotretinoin.
7) The booklet for females of reproductive potential, includes a referral program that offers female patients free contraception counseling, reimbursed by the manufacturer, by a reproductive specialist; and a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form concerning birth defects.
8) The booklet, includes information on the types of contraceptive methods, the selection and use of appropriate, effective contraception, the rates of possible contraceptive failure and a toll-free contraception counseling line.
9) In addition, there are patient educational material with the following videos — “Be Prepared, Be Protected” and “Be Aware: The Risk of Pregnancy While on isotretinoin” (see ).
| Primary forms | Seconday forms | |
| tubal sterilization | Barrier: | |
| partner’s vasectomy | male latex condom with or without spermicide | |
| intrauterine device | diaphragm with spermicide | |
| hormonal (combination oral contraceptives,transdermal patch,injectables, implantables, or vaginal ring) | cervical cap with spermicide | |
| Other:vaginal sponge (contains spermicide) |
General
- Patients must be instructed to read the Medication Guide supplied as required by law when Zenatane is dispensed. The complete text of the Medication Guide is reprinted at the end of this document. For additional information, patients must also be instructed to read the iPLEDGE program patient educational materials. All patients must sign the Patient Information/Informed Consent (for all patients) form.
- Female Females of reproductive potential must be instructed that they must not be pregnant when Zenatane therapy is initiated, and that they should use 2 forms of effective contraception simultaneously for 1 month before starting Zenatane, while taking Zenatane, and for 1 month after Zenatane has been stopped, unless they commit to continuous abstinence from heterosexual intercourse. They should also sign a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form prior to beginning Zenatane therapy. They should be given an opportunity to view the patient video provided by the manufacturer to the prescriber. The video includes information about contraception, the most common reasons that contraception fails, and the importance of using 2 forms of effective contraception when taking teratogenic drugs and comprehensive information about types of potential birth defects which could occur if a female patient who is pregnant takes Zenatane at any time during pregnancy. Female patients should be seen by their prescribers monthly and have a urine or serum pregnancy test, in a CLIA-certified laboratory, performed each month during treatment to confirm negative pregnancy status before another Zenatane prescription is written (see and ).
- Zenatane is found in the semen of male patients taking Zenatane, but the amount delivered to a female partner would be about 1 million times lower than an oral dose of 40 mg. While the no-effect limit for isotretinoin induced embryopathy is unknown, 20 years of post-marketing reports include 4 with isolated defects compatible with features of retinoid exposed fetuses; however 2 of these reports were incomplete, and two had other possible explanations for the defects observed.
- Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of Zenatane treatment, patients and family members should be asked about any history of psychiatric disorder, and at each visit during treatment patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. . Patients should stop Zenatane and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Zenatane treatment may be insufficient; further evaluation may be necessary. While such monitoring may be helpful, it may not detect all patients at risk. Patients may report mental health problems or family history of psychiatric disorders. These reports should be discussed with the patient and/or the patient’s family. A referral to a mental health professional may be necessary. The physician should consider whether Zenatane therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Zenatane therapy.
- Patients must be informed that some patients, while taking Zenatane or soon after stopping Zenatane, have become depressed or developed other serious mental problems. Symptoms of depression include sad, “anxious” or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking Zenatane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on Zenatane becoming aggressive or violent. No one knows if isotretinoin caused these behaviors or if they would have happened even if the person did not take Zenatane. Some people have had other signs of depression while taking Zenatane.
- Patients must be informed that they must not share Zenatane with anyone else because of the risk of birth defects and other serious adverse events.
- Patients must be informed not to donate blood during therapy and for one month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to Zenatane.
- Patients should be reminded to take Zenatane with a meal (see ). To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid.
- Patients should be informed that transient exacerbation (flare) of acne has been seen, generally during the initial period of therapy.
- Wax epilation and skin resurfacing procedures (such as dermabrasion, laser) should be avoided during Zenatane therapy and for at least 6 months thereafter due to the possibility of scarring (see ).
- Patients should be advised to avoid prolonged exposure to UV rays or sunlight.
- Patients should be informed that they may experience decreased tolerance to contact lenses during and after therapy.
- Patients should be informed that approximately 16% of patients treated with Zenatane in a clinical trial developed musculoskeletal symptoms (including arthralgia) during treatment. In general, these symptoms were mild to moderate, but occasionally required discontinuation of the drug. Transient pain in the chest has been reported less frequently. In the clinical trial, these symptoms generally cleared rapidly after discontinuation of Zenatane, but in some cases persisted (see ). There have been rare post marketing reports of rhabdomyolysis, some associated with strenuous physical activity (see ).
- Pediatric patients and their caregivers should be informed that approximately 29% (104/358) of pediatric patients treated with Zenatane developed back pain. Back pain was severe in 13.5% (14/104) of the cases and occurred at a higher frequency in female patients than male patients. Arthralgias were experienced in 22% (79/358) of pediatric patients. Arthralgias were severe in 7.6% (6/79) of patients. Appropriate evaluation of the musculoskeletal system should be done in patients who present with these symptoms during or after a course of Zenatane. Consideration should be given to discontinuation of Zenatane if any significant abnormality is found.
- Neutropenia and rare cases of agranulocytosis have been reported. Zenatane should be discontinued if clinically significant decreases in white cell counts occur.
- Patients should be advised that severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in post-marketing data. Zenatane should be discontinued if clinically significant skin reactions occur.
Although an effect of Zenatane on bone loss is not established, physicians should use caution when prescribing Zenatane to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. This would include patients diagnosed with anorexia nervosa and those who are on chronic drug therapy that causes drug-induced osteoporosis/osteomalacia and/or affects vitamin D metabolism, such as systemic corticosteroids and any anticonvulsant.
Patients may be at increased risk when participating in sports with repetitive impact where the risks of spondylolisthesis with and without pars fractures and hip growth plate injuries in early and late adolescence are known. There are spontaneous reports of fractures and/or delayed healing in patients while on therapy with Zenatane or following cessation of therapy with isotretinoin while involved in these activities. While causality to Zenatane has not been established, an effect must not be ruled out.
Information for Patients
See and .
Hypersensitivity
Anaphylactic reactions and other allergic reactions have been reported. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement (including renal) have been reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.
Drug Interactions
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Vitamin A:
Tetracyclines:
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Norethindrone/ethinyl estradiol:
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Phenytoin:
Systemic Corticosteroids:
Drug Interactions
Laboratory Tests
Pregnancy Test:
- Pregnancy Test:
Lipids:
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Liver Function Tests:
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Glucose:
CPK:
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- Females of reproductive potential have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Zenatane prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue qualification of the patient for Zenatane. The second pregnancy test (a confirmation test) must be done in a CLIA-certified laboratory. The interval between the two tests must be at least 19 days.
- For patients with regular menstrual cycles, the second pregnancy test must be done during the first 5 days of the menstrual period immediately preceding the beginning of Zenatane therapy and after the patient has used 2 forms of contraception for 1 month.
- For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done immediately preceding the beginning of Zenatane therapy and after the patient has used 2 forms of contraception for 1 month.
- Each month of therapy, patients must have a negative result from a urine or serum pregnancy test. A pregnancy test must be repeated each month, in a CLIA-certified laboratory, prior to the female patient receiving each prescription.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis, Mutagenesis and Impairment of Fertility
In male and female Fischer 344 rats given oral isotretinoin at dosages of 8 or 32 mg/kg/day (1.3 to 5.3 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area) for greater than 18 months, there was a dose related increased incidence of pheochromocytoma relative to controls. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas occurring in the male Fischer 344 rat makes it an equivocal model for study of this tumor; therefore, the relevance of this tumor to the human population is uncertain.
The Ames test was conducted with isotretinoin in two laboratories. The results of the tests in one laboratory were negative while in the second laboratory a weakly positive response (less than 1.6 x background) was noted in TA100 when the assay was conducted with metabolic activation. No dose-response effect was seen and all other strains were negative. Additionally, other tests designed to assess genotoxicity (Chinese hamster cell assay, mouse micronucleus test, D7 assay, in vitro clastogenesis assay with human-derived lymphocytes, and unscheduled DNA synthesis assay) were all negative.
In rats, no adverse effects on gonadal function, fertility, conception rate, gestation or parturition were observed at oral dosages of isotretinoin of 2, 8, or 32 mg/kg/day (0.3, 1.3, or 5.3 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area).
In dogs, testicular atrophy was noted after treatment with oral isotretinoin for approximately 30 weeks at dosages of 20 or 60 mg/kg/day (10 or 30 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area). In general, there was microscopic evidence for appreciable depression of spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic tubules seen. In studies of 66 men, 30 of whom were patients with nodular acne under treatment with oral isotretinoin, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men (ages 17 to 32 years) receiving isotretinoin therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
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Nursing Mothers
It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Zenatane.
Pediatric Use
The use of Zenatane in pediatric patients less than 12 years of age has not been studied. The use of Zenatane for the treatment of severe recalcitrant nodular acne in pediatric patients ages 12 to 17 years should be given careful consideration, especially for those patients where a known metabolic or structural bone disease exists (see ). Use of Zenatane in this age group for severe recalcitrant nodular acne is supported by evidence from a clinical study comparing 103 pediatric patients (13 to 17 years) to 197 adult patients (≥18 years). Results from this study demonstrated that Zenatane, at a dose of 1 mg/kg/day given in two divided doses, was equally effective in treating severe recalcitrant nodular acne in both pediatric and adult patients.
In studies with Zenatane, adverse reactions reported in pediatric patients were similar to those described in adults except for the increased incidence of back pain and arthralgia (both of which were sometimes severe) and myalgia in pediatric patients (see ).
In an open-label clinical trial (N=217) of a single course of therapy with Zenatane for severe recalcitrant nodular acne, bone density measurements at several skeletal sites were not significantly decreased (lumbar spine change >-4% and total hip change >-5%) or were increased in the majority of patients. One patient had a decrease in lumbar spine bone mineral density >4% based on unadjusted data. Sixteen (7.9%) patients had decreases in lumbar spine bone mineral density >4%, and all the other patients (92%) did not have significant decreases or had increases (adjusted for body mass index). Nine patients (4.5%) had a decrease in total hip bone mineral density >5% based on unadjusted data. Twenty-one (10.6%) patients had decreases in total hip bone mineral density >5%, and all the other patients (89%) did not have significant decreases or had increases (adjusted for body mass index). Follow-up studies performed in eight of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in five patients at the lumbar spine, while the other three patients had lumbar spine bone density measurements below baseline values. Total hip bone mineral densities remained below baseline (range −1.6% to −7.6%) in 5 of 8 patients (62.5%).
In a separate open-label extension study of ten patients, ages 13 to 18 years, who started a second course of Zenatane 4 months after the first course, two patients showed a decrease in mean lumbar spine bone mineral density up to 3.25% (see ).
Geriatric Use
Clinical studies of isotretinoin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Although reported clinical experience has not identified differences in responses between elderly and younger patients, effects of aging might be expected to increase some risks associated with isotretinoin therapy (see and ).
What are the side effects of ZENATANE?
Array
Clinical Trials and Post-marketing Surveillance
The adverse reactions listed below reflect the experience from investigational studies of Zenatane, and the post-marketing experience. The relationship of some of these events to Zenatane therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Zenatane are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).
Array
Dose Relationship
Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see and ).
Body as a Whole
allergic reactions, including vasculitis, systemic hypersensitivity (see ), edema, fatigue, lymphadenopathy, weight loss
Cardiovascular
palpitation, tachycardia, vascular thrombotic disease, stroke
Endocrine/Metabolic
hypertriglyceridemia (see ), alterations in blood sugar levels (see )
Gastrointestinal
inflammatory bowel disease (see ), hepatitis (see ), pancreatitis (see ), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms
Hematologic
allergic reactions (see ), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see ). See for other hematological parameters.
Musculoskeletal
skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density (see ), musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia (see ), transient pain in the chest (see ), arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis (see ).
Neurological
pseudotumor cerebri (see ), dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness
Psychiatric
suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors (see ), emotional instability
Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.
Reproductive System
Abnormal menses
Respiratory
bronchospasms (with or without a history of asthma), respiratory infection, voice alteration
Skin and Appendages
acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas,erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson Syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener’s granulomatosis; see ), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see )
Special Senses
Hearing
Vision
corneal opacities (see ), decreased night vision which may persist (see ), cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances
Urinary System
glomerulonephritis (see ), nonspecific urogenital findings (see for other urological parameters)
Array
Laboratory
Elevation of plasma triglycerides (see ), decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment
Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH (see )
Elevation of fasting blood sugar, elevations of CPK (see ), hyperuricemia
Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see ), elevated sedimentation rates, elevated platelet counts, thrombocytopenia
White cells in the urine, proteinuria, microscopic or gross hematuria
Array
What should I look out for while using ZENATANE?
Pregnancy: Category X. See .
Allergic Reactions
What might happen if I take too much ZENATANE?
The oral LDof isotretinoin is greater than 4000 mg/kg in rats and mice (>600 times the recommended clinical dose of 1.0 mg/kg/day after normalization of the rat dose for total body surface area and >300 times the recommended clinical dose of 1.0 mg/kg/day after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (653 times the recommended clinical dose of 1.0 mg/kg/day after normalization for total body surface area). In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects.
Zenatane causes serious birth defects at any dosage (see AND). Females of reproductive potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the AND
. Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in . Educational materials for such patients can be obtained by calling the manufacturer. Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for one month after the overdose. All patients with isotretinoin overdose should not donate blood for at least one month.
How should I store and handle ZENATANE?
StorageStore at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.StorageStore at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615 Zenatane™ (isotretinoin capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78Zenatane™ (isotretinoin capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blistersBoxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78Zenatane™ (isotretinoin capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes 100 containing 10 prescription packs of 10 capsules, as unit dose blisters.Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78Zenatane™ (isotretinoin capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81Boxes of 100(10 Prescription Packs of 10 capsules) NDC 55111-137-78StorageStore at 68° to 77°F (20° to 25°C) [See USP Controlled Room Temperature]. Protect from light. REFERENCES1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 300:329-333, 1979. 2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991. 3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne withevaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980. 4. Jones H, Blanc D, Cunliffe WJ. 2:1048-1049, 1980. 5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral isotretinoin in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980. 6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Isotretinoin therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984. 7. Dicken CH, Connolly SM. Eruptive xanthomas associated with isotretinoin Arch Dermatol 116:951-952, 1980. 8. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.Rx OnlyManufactured by:Cipla LimitedPune – 413 802 INDIAManufactured for:Dr. Reddy’s Laboratories LimitedRevised: 0615
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with Zenatane, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.
Non-Clinical Toxicology
Pregnancy: Category X. See .Allergic Reactions
Drug Interactions
Zenatane must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Zenatane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Zenatane only from wholesalers registered with iPLEDGE.
iPLEDGE Program requirements for wholesalers, prescribers, and pharmacists are described below:
Wholesalers:
For the purpose of the iPLEDGE Program, the term wholesaler refers to wholesaler, distributor, and/or chain pharmacy distributor. To distribute Zenatane, wholesalers must be registered with iPLEDGE, and agree to meet all iPLEDGE requirements for wholesale distribution of isotretinoin products. Wholesalers must register with iPLEDGE by signing and returning the iPLEDGE wholesaler agreement that affirms they will comply with all iPLEDGE requirements for distribution of isotretinoin. These include:
-wholesalers registered in the iPLEDGE Program with prior written consent from the manufacturer or
-pharmacies licensed in the US and registered and activated in the iPLEDGE Program
Prescribers:
To prescribe isotretinoin, the prescriber must be registered and activated with the pregnancy risk management program iPLEDGE. Prescribers can register by signing and returning the completed registration form. Prescribers can only activate their registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
To prescribe isotretinoin, the prescriber must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to:
1) Register each patient in the iPLEDGE Program.
2) Confirm monthly that each patient has received counseling and education.
3) For females of reproductive potential:
Isotretinoin must only be prescribed to female patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test.
Isotretinoin must only be dispensed by a pharmacy registered and activated with the pregnancy risk management program iPLEDGE and only when the registered patient meets all the requirements of the iPLEDGE Program. Meeting the requirements for a female of reproductive potential signifies that she:
-For patients with regular menstrual cycles, the second pregnancy test should be done during the first 5 days of the menstrual period immediately preceding the beginning of isotretinoin therapy and after the patient has used two forms of contraception for one month.
-For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done immediately preceding the beginning of isotretinoin therapy and after the patient has used two forms of contraception for one month.
If the patient has unprotected heterosexual intercourse at any time 1 month before, during, or 1 month after therapy, she must:
1. Stop taking Zenatane immediately, if on therapy
2. Have a pregnancy test at least 19 days after the last act of unprotected heterosexual intercourse
3. Start using 2 forms of effective contraception simultaneously again for 1 month before resuming Zenatane therapy
4. Have a second pregnancy test after using 2 forms of effective contraception for 1 month as described above depending on whether she has regular menses or not.
Effective forms of contraception include both primary and secondary forms of contraception:
Any birth control method can fail. There have been reports of pregnancy from female patients who have used oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products; these pregnancies occurred while these patients were taking Zenatane. These reports are more frequent for female patients who use only a single method of contraception. Therefore, it is critically important that females of reproductive potential use two effective forms of contraception simultaneously. Patients must receive written warnings about the rates of possible contraception failure (included in patient education kits).
Using two forms of contraception simultaneously substantially reduces the chances that a female will become pregnant over the risk of pregnancy with either form alone. A drug interaction that decreases effectiveness of hormonal contraceptives has not been entirely ruled out for Zenatane (see ). Although hormonal contraceptives are highly effective, prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort.
If a pregnancy does occur during Zenatane treatment, Zenatane must be discontinued immediately. The patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure during or one month after Zenatane therapy must be reported immediately to the FDA via the MedWatch number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet ().
All Patients
Isotretinoin is contraindicated in female patients who are pregnant. To receive isotretinoin all patients must meet all of the following conditions:
Females of Reproductive Potential
Isotretinoin is contraindicated in female patients who are pregnant. In addition to the requirements for all patients described above, females of reproductive potential must meet the following conditions:
Pharmacists:
To dispense isotretinoin, pharmacies must be registered and activated with the pregnancy risk management program iPLEDGE.
The Responsible Site Pharmacist must register the pharmacy by signing and returning the completed registration form. After registration, the Responsible Site Pharmacist can only activate the pharmacy registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
To dispense isotretinoin, the pharmacist must:
1) be trained by the Responsible Site Pharmacist concerning the iPLEDGE Program requirements.
2) obtain authorization from the iPLEDGE Program via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) for every isotretinoin prescription. Authorization signifies that the patient has met all program requirements and is qualified to receive Zenatane.
3) write the Risk Management Authorization (RMA) number on the prescription.
Zenatane must only be dispensed:
A Zenatane Medication Guide must be given to the patient each time Zenatane is dispensed, as required by law. This Zenatane Medication Guide is an important part of the risk management program for the patients.
Zenatane must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE Program. Only FDA-approved Zenatane products must be distributed, prescribed, dispensed, and used. Patients must obtain Zenatane™ prescriptions only at US licensed pharmacies.
A description of the iPLEDGE Program educational materials available with iPLEDGE is provided below. The main goal of these educational materials is to explain the iPLEDGE Program requirements and to reinforce the educational messages.
1) isotretinoin teratogenic potential, information on pregnancy testing, and the method to complete a qualified Zenatane prescription.
2) specific information about effective contraception, the limitations of contraceptive methods, behaviors associated with an increased risk of contraceptive failure and pregnancy and the methods to evaluate pregnancy risk.
3) isotretinoin teratogenic potential and the method to obtain authorization to dispense an isotretinoin prescription.
4) The iPLEDGE Program is a systematic approach to comprehensive patient education about their responsibilities and includes education for contraception compliance and reinforcement of educational messages. The iPLEDGE Program includes information on the risks and benefits of Zenatane which is linked to the Medication Guide dispensed by pharmacists with each isotretinoin prescription.
5) Females of non-reproductive potential and male patients, and females of reproductive potential are provided with separate booklets. Each booklet contains information on isotretinoin therapy including precautions and warnings, a Patient Information/Informed Consent (for all patients) form, and a toll-free line which provides Zenatane information in two languages.
6) The booklet for females of non-reproductive potential and male patients, also includes information about male reproduction and a warning not to share Zenatane with others or to donate blood during isotretinoin therapy and for one month following discontinuation of isotretinoin.
7) The booklet for females of reproductive potential, includes a referral program that offers female patients free contraception counseling, reimbursed by the manufacturer, by a reproductive specialist; and a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form concerning birth defects.
8) The booklet, includes information on the types of contraceptive methods, the selection and use of appropriate, effective contraception, the rates of possible contraceptive failure and a toll-free contraception counseling line.
9) In addition, there are patient educational material with the following videos — “Be Prepared, Be Protected” and “Be Aware: The Risk of Pregnancy While on isotretinoin” (see ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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