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Sotret

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Overview

What is Sotret?

Isotretinoin, a retinoid, is available as Sotret in 10 mg, 20 mg, 30 mg, and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil, hydrogenated vegetable oil, iron oxide black, soybean oil and white wax. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 30 mg - FD&C Yellow No. 6, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.

Chemically, isotretinoin is 13-retinoic acid and is related to both retinoic acid and retinol (vitamin A).

It is a yellow to orange crystalline powder with a molecular weight of 300.44. The structural formula is:



What does Sotret look like?



What are the available doses of Sotret?

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What should I talk to my health care provider before I take Sotret?

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How should I use Sotret?

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What interacts with Sotret?

Sorry No Records found


What are the warnings of Sotret?

Psychiatric Disorders

Sotret may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts,

suicide

and aggressive and/or violent behaviors. No mechanism of action has been established

for these events

(see

ADVERSE REACTIONS: Psychiatric

Prescribers should

read the brochure

Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin

should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of Sotret

therapy, patients and family members should be asked about any history of psychiatric

disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may

be necessary. Signs and symptoms of depression, as described in the brochure (“Recognizing Psychiatric Disorders in Adolescents and Young Adults”), include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in

activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment. Patients should stop Sotret 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 Sotret therapy 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 Sotret therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of isotretinoin therapy

Pseudotumor Cerebri

Isotretinoin capsule 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 Sotret immediately and be

referred to a neurologist for further diagnosis and care

(see

ADVERSE REACTIONS: Neurological

Pancreatitis

Acute pancreatitis

In rare instances, fatal hemorrhagic pancreatitis has been reported.

Lipids

Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with isotretinoin capsules. Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving isotretinoin capsules 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 isotretinoin capsules 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 isotretinoin capsules.

Blood lipid determinations should be performed before Sotret is given and then at intervals until the lipid response to Sotret 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 Sotret therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Sotret 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 Sotret are unknown.

Animal Studies:

Hearing Impairment

Impaired hearing has been reported in patients taking isotretinoin capsules; 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 Sotret treatment and be referred for specialized care for further evaluation (see : Special Senses).

Hepatotoxicity

Clinical hepatitis considered to be possibly or probably related to isotretinoin capsules 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 Sotret, the drug should be discontinued and the etiology further investigated.

Inflammatory Bowel Disease

Isotretinoin capsules have 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 isotretinoin capsules treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Sotret immediately (see ).

Skeletal

Effects of multiple courses of Sotret 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 isotretinoin 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 8 of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in 5 patients at the lumbar spine, while the other 3 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 10 patients, ages 13 to 18 years, who started a second course of isotretinoin 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 isotretinoin population. While causality to Sotret has not been established, an effect cannot be ruled out. Longer term effects have not been studied. It is important that Sotret be given at the recommended doses for no longer than the recommended duration.

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 Sotret 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 isotretinoin capsules given in two divided doses. Hyperostosis may require a longer time frame to appear. The clinical course and significance remain unknown.

There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of isotretinoin capsules. The effect of multiple courses of Sotret on epiphyseal closure is unknown.

Vision Impairment

Visual problems should be carefully monitored. All Sotret patients experiencing visual difficulties should discontinue Sotret treatment and have an ophthalmological examination (see Special Senses).

Corneal opacities have occurred in patients receiving isotretinoin capsules 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 isotretinoin capsules have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug (see Special Senses).

Decreased night vision has been reported during isotretinoin capsules 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.


What are the precautions of Sotret?

Sotret must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Sotret must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive isotretinoin only from wholesalers registered with iPLEDGE.

iPLEDGE program requirements for wholesalers, prescribers, and pharmacists are described below:

Wholesalers:

  • Registering prior to distributing isotretinoin and reregistering annually thereafter
  • Distributing only FDA approved isotretinoin product
  • Only shipping isotretinoin to


  • Notifying the isotretinoin manufacturer (or delegate) of any non-registered and/or non-activated pharmacy or unregistered wholesaler that attempts to order isotretinoin
  • Complying with inspection of wholesaler records for verification of compliance with the iPLEDGE program by the isotretinoin manufacturer (or delegate)
  • Returning to the manufacturer (or delegate) any undistributed product if registration is revoked by the manufacturer or if the wholesaler chooses to not reregister annually
  • Providing product flow data to manufacturer (or delegate) as detailed in the wholesalers agreement


For the purpose of the iPLEDGE program, the term wholesaler refers to wholesaler, distributor, and/or chain pharmacy distributor. To distribute Sotret, 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:

Prescribers:

  • I know how to diagnose and treat the various presentations of acne.
  • I know the risk and severity of fetal injury/birth defects from isotretinoin.
  • I know the risk factors for unplanned pregnancy and the effective measures for avoidance of unplanned pregnancy.
  • I have the expertise to provide the patient with detailed pregnancy prevention counseling or I will refer her to an expert for such counseling, reimbursed by the manufacturer.
  • I will comply with the iPLEDGE program requirements described in the booklets entitled and .
  • Before beginning treatment of female patients of childbearing potential with isotretinoin and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continuously one month before, during, and one month after isotretinoin therapy, unless the patient commits to continuous abstinence.
  • I will not prescribe isotretinoin to any female patient of childbearing potential until verifying she has a negative screening pregnancy test and monthly negative CLIA-certified (Clinical Laboratory Improvement Amendment) pregnancy tests. Patients should have a pregnancy test at the completion of the entire course of isotretinoin and another pregnancy test 1 month later.
  • I will report any pregnancy case that I become aware of while the female patient is on isotretinoin or 1 month after the last dose to the pregnancy registry.


  • Register each patient in the iPLEDGE program.
  • Confirm monthly that each patient has received counseling and education.
  • For :


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  • Stop taking isotretinoin immediately, if on therapy
  • Have a pregnancy test at least 19 days after the last act of unprotected heterosexual intercourse
  • Start using 2 forms of effective contraception simultaneously again for 1 month before resuming isotretinoin therapy
  • 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.


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 () or telephone (1-866-495-0654) to:

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 patient of childbearing potential signifies that she:

If the patient has unprotected heterosexual intercourse at any time 1 month before, during, or 1 month after therapy, she must:

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 isotretinoin capsules. These reports are more frequent for female patients who use only a single method of contraception. Therefore, it is critically important that female patients of childbearing potential use 2 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 Sotret (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 isotretinoin treatment, isotretinoin 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 1 month after isotretinoin 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 ().

Primary formsSecondary forms
Barrier forms (always used with spermicide):
• tubal sterilization• male latex condom
• partner’s vasectomy• diaphragm
• intrauterine device• cervical cap
• hormonal (combination oral contraceptives, transdermal patch, injectables, implantables, or vaginal ring)Others:


All Patients

Isotretinoin is contraindicated in female patients who are pregnant. To receive isotretinoin all patients must meet all of the following conditions:

Female Patients of Childbearing Potential

Isotretinoin is contraindicated in female patients who are pregnant. In addition to the requirements for all patients described above, female patients of childbearing potential must meet the following conditions:

Pharmacists:

  • I know the risk and severity of fetal injury/birth defects from isotretinoin.
  • I will train all pharmacists, who participate in the filling and dispensing of isotretinoin prescriptions, on the iPLEDGE program requirements.
  • I will comply and seek to ensure all pharmacists who participate in the filling and dispensing of isotretinoin prescriptions comply with the iPLEDGE program requirements described in the booklet entitled .
  • I will obtain isotretinoin product only from iPLEDGE registered wholesalers.
  • I will not sell, buy, borrow, loan or otherwise transfer isotretinoin in any manner to or from another pharmacy.
  • I will return to the manufacturer (or delegate) any unused product if registration is revoked by the manufacturer or if the pharmacy chooses to not reactivate annually.
  • I will not fill isotretinoin for any party other than a qualified patient.


  • be trained by the Responsible Site Pharmacist concerning the iPLEDGE program requirements.
  • obtain authorization from the iPLEDGE program via the internet () 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 isotretinoin.
  • write the Risk Management Authorization (RMA) number on the prescription.


  • in no more than a 30-day supply
  • with a Sotret Medication Guide
  • after authorization from the iPLEDGE program
  • prior to the “do not dispense to patient after” date provided by the iPLEDGE system (within 7 days of the office visit)
  • with a new prescription for refills and another authorization from the iPLEDGE program (No automatic refills are allowed)


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  • 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 isotretinoin which is linked to the Medication Guide dispensed by pharmacists with each isotretinoin prescription.
  • Female patients not of childbearing potential and male patients, and female patients of childbearing 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 isotretinoin information in 2 languages.
  • The booklet for female patients not of childbearing potential and male patients, , also includes information about male reproduction and a warning not to share isotretinoin with others or to donate blood during isotretinoin therapy and for 1 month following discontinuation of isotretinoin.
  • The booklet for female patients of childbearing 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.
  • 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.
  • In addition, there is a patient educational DVD with the following videos —“Be Prepared, Be Protected” and “Be Aware: The Risk of Pregnancy While on Isotretinoin” (see ).


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:

Sotret must only be dispensed:

A Sotret Medication Guide must be given to the patient each time Sotret is dispensed, as required by law. This Sotret Medication Guide is an important part of the risk management program for the patients.

Sotret must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE program. Only FDA-approved Sotret products must be distributed, prescribed, dispensed, and used. Patients must fill Sotret 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.

General

Although an effect of Sotret on bone loss is not established, physicians should use caution when prescribing Sotret 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 isotretinoin or following cessation of therapy with isotretinoin while involved in these activities. While causality to Sotret has not been established, an effect must not be ruled out.

Information for Patients































                                See and .

                                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.

                                Micro-dosed Progesterone Preparations

                                PRECAUTIONS)

                                St. John’s Wort

                                Isotretinoin capsules use is associated with depression in some patients (see WARNINGS: Psychiatric Disorders and

                                ADVERSE REACTIONS: Psychiatric

                                Phenytoin

                                in vitro

                                Laboratory Tests

                                Pregnancy Test

                                • Female patients of childbearing potential have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Sotret prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue qualification of the patient for Sotret. 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 and within 7 days following the office visit, immediately preceding the beginning of Sotret 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 within 7 days following the office visit, immediately preceding the beginning of Sotret 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.


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                                Carcinogenesis and 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 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, 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 Sotret (isotretinoin) therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.

                                Pregnancy: Category X.

                                See Boxed CONTRAINDICATIONS AND WARNINGS.

                                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 Sotret.

                                Pediatric Use

                                The use of isotretinoin capsules in pediatric patients less than 12 years of age has not been studied. The use of isotretinoin capsules 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 isotretinoin capsules 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 isotretinoin, 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 isotretinoin capsules, 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 isotretinoin capsules 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 decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in 5 patients at the lumbar spine, while the other 3 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 10 patients, ages 13 to 18 years, who started a second course of isotretinoin capsules 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 Sotret?

                                Clinical Trials and Postmarketing Surveillance

                                The adverse reactions listed below reflect the experience from investigational studies of isotretinoin capsules, and the postmarketing experience. The relationship of some of these events to isotretinoin capsules therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving isotretinoin capsules 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).

                                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 ).

                                allergic reactions, including vasculitis, systemic hypersensitivity (see ), edema, fatigue, lymphadenopathy, weight loss

                                palpitation, tachycardia, vascular thrombotic disease, stroke

                                hypertriglyceridemia (see ), alterations in blood sugar levels (see )

                                inflammatory bowel disease (see ), hepatitis (see pancreatitis (see ), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms

                                allergic reactions (see ), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see ). See for other hematological parameters.

                                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 ).

                                pseudotumor cerebri (see ), dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness

                                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.

                                abnormal menses

                                bronchospasms (with or without a history of asthma ), respiratory infection, voice alteration

                                acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, 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), sunburn susceptibility increased, sweating, urticaria, vasculitis (including Wegener’s granulomatosis; see ), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see )

                                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


                                What should I look out for while using Sotret?


                                What might happen if I take too much Sotret?

                                The oral LD of 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 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.

                                Isotretinoin causes serious birth defects at any dosage (see ). Female patients of childbearing 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 b. 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 1 month after the overdose. All patients with isotretinoin overdose should not donate blood for at least 1 month.


                                How should I store and handle Sotret?

                                Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.Soft gelatin capsules, 10 mg (light pink), imprinted “5R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-584-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-584-77)Soft gelatin capsules, 20 mg (maroon), imprinted “6R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-585-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-585-77)Soft gelatin capsules, 30 mg (golden yellow), imprinted “8R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-447-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-447-77)Soft gelatin capsules, 40 mg (yellow), imprinted “7R”.Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 10631-586-31)Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 10631-586-77)Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from light.


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                                Clinical Information

                                Chemical Structure

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                                Clinical 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 Sotret, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.

                                Non-Clinical Toxicology
                                Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients receiving Visken (pindolol) plus a catecholamine-depleting agent should, therefore, be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension.

                                Array

                                Visken (pindolol) has been used with a variety of antihypertensive agents, including hydrochlorothiazide, hydralazine, and guanethidine without unexpected adverse interactions.

                                Array

                                Visken (pindolol) has been shown to increase serum thioridazine levels when both drugs are co-administered. Visken (pindolol) levels may also be increased with this combination.

                                Array

                                Sotret must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Sotret must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive isotretinoin only from wholesalers registered with iPLEDGE.

                                iPLEDGE program requirements for wholesalers, prescribers, and pharmacists are described below:

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                                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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                                Professional

                                Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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                                Interactions

                                Interactions

                                A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).