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Amnesteem

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Overview

What is Amnesteem?

Isotretinoin, USP a retinoid, is available as Amnesteem (isotretinoin capsules, USP) in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains yellow wax, butylated hydroxyanisole, edetate disodium, hydrogenated vegetable oil and soybean oil. Gelatin capsules contain glycerin, with the following dye systems: 10 mg – red iron oxide paste and black ink; 20 mg – red iron oxide paste, yellow iron oxide paste, titanium dioxide and black ink; 40 mg – red iron oxide paste, yellow iron oxide paste, titanium dioxide and black ink.

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 Amnesteem look like?



What are the available doses of Amnesteem?

Sorry No records found.

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

Sorry No records found

How should I use Amnesteem?

Amnesteem should be administered with a meal (see ).

The recommended dosage range for Amnesteem is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5 and 1 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 mg/kg/day, as tolerated. Failure to take Amnesteem 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 Amnesteem 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 Amnesteem, even in low doses, has not been studied, and is not recommended. It is important that Amnesteem be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Amnesteem on bone loss is unknown (see , , and ).

Contraceptive measures must be followed for any subsequent course of therapy (see ).

 

Access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to obtain an authorization and the date. Amnesteem must only be dispensed in no more than a 30 day supply.

REFILLS REQUIRE A NEW PRESCRIPTION AND A NEW AUTHORIZATION FROM THE iPLEDGE SYSTEM.

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


What interacts with Amnesteem?

Pregnancy: Category X. See .


Allergic Reactions


Amnesteem is contraindicated in patients who are hypersensitive to this medication or to any of its components (see ).



What are the warnings of Amnesteem?

Psychiatric Disorders

Amnesteem 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 ). Prescribers should read the brochure, 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 Amnesteem 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 Amnesteem 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 Amnesteem 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 Amnesteem therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Amnesteem therapy.

Pseudotumor Cerebri

Amnesteem 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 Amnesteem immediately and be referred to a neurologist for further diagnosis and care (see ).

Serious Skin Reactions

There have been post-marketing reports of erythema multiforme and severe skin reactions [e.g., 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 Amnesteem should be considered if warranted.

Pancreatitis

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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 Amnesteem. Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Amnesteem 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 Amnesteem 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 Amnesteem.

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

In rats given 8 or 32 mg/kg/day of isotretinoin (1.3 to 5.3 times the recommended clinical dose of 1 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 mg/kg/day, respectively, after normalization for total body surface area).

Hearing Impairment

Impaired hearing has been reported in patients taking Amnesteem; 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 Amnesteem treatment and be referred for specialized care for further evaluation (see ).

Hepatotoxicity

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

Inflammatory Bowel Disease

Amnesteem 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 Amnesteem treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Amnesteem immediately (see ).

Skeletal

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

Vision Impairment

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

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

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Decreased night vision has been reported during Amnesteem 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 Amnesteem?

Amnesteem must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Amnesteem 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 Amnesteem only from wholesalers registered with iPLEDGE.

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

Wholesalers

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For the purpose of the iPLEDGE Program, the term wholesaler refers to wholesaler, distributor and/or chain pharmacy distributor. To distribute Amnesteem, 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

The Guide to Best Practices for the iPLEDGE Program

The iPLEDGE Program Prescriber Contraception Counseling Guide.

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females of reproductive potential:

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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:

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:

If the patient has unprotected heterosexual intercourse at any time one month before, during or one 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 Amnesteem. 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 Amnesteem (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 Amnesteem treatment, Amnesteem 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 Amnesteem 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 (www.ipledgeprogram.com).

Primary forms


All Patients

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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

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

Pharmacists

Pharmacist Guide for the iPLEDGE Program

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The

Guide to Best Practices for the iPLEDGE Program

The

iPLEDGE Program Prescriber Contraception Counseling Guide

The Pharmacist Guide for the iPLEDGE Program

The iPLEDGE Program Guide to Isotretinoin for Male Patients and Female Patients Who Cannot Get Pregnant

The iPLEDGE

Program Guide to Isotretinoin for Female Patients Who Can Get Pregnant

The iPLEDGE

Program Birth Control Workbook

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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:

Amnesteem must only be dispensed:

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

Amnesteem must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE Program. Only FDA-approved Amnesteem products must be distributed, prescribed, dispensed and used. Patients must obtain Amnesteem prescriptions only at U.S. 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 Amnesteem on bone loss is not established, physicians should use caution when prescribing Amnesteem 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 Amnesteem or following cessation of therapy with Amnesteem while involved in these activities. While causality to Amnesteem has not been established, an effect must not be ruled out.

Information for Patients

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Signs and symptoms of depression 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.

























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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Tetracyclines:



Micro-dosed Progesterone Preparations:



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Systemic Corticosteroids:

Laboratory Tests

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Pretreatment and follow-up blood lipids should be obtained under fasting conditions. After consumption of alcohol, at least 36 hours should elapse before these determinations are made. It is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Amnesteem is established. The incidence of hypertriglyceridemia is one patient in four on Amnesteem therapy (see  ).

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Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Amnesteem has been established (see ).

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Some patients receiving Amnesteem have experienced problems in the control of their blood sugar. In addition, new cases of diabetes have been diagnosed during Amnesteem therapy, although no causal relationship has been established.

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Some patients undergoing vigorous physical activity while on Amnesteem therapy have experienced elevated CPK levels; however, the clinical significance is unknown. There have been rare post-marketing reports of rhabdomyolysis, some associated with strenuous physical activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, transient elevations in CPK were observed in 12% of patients, including those undergoing strenuous physical activity in association with reported musculoskeletal adverse events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients, approximately half of the CPK elevations returned to normal within 2 weeks and half returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial.

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

Pregnancy

See

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 Amnesteem.

Pediatric Use

The use of Amnesteem in pediatric patients less than 12 years of age has not been studied. The use of Amnesteem 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 Amnesteem 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 Amnesteem, 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 Amnesteem, 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 Amnesteem 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 Amnesteem 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 Amnesteem?

Clinical Trials and Post-marketing Surveillance

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

Body as a Whole:

Cardiovascular:

Endocrine/Metabolic:

Gastrointestinal:

Hematologic:

Musculoskeletal:

Neurological:

Psychiatric:

Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

Reproductive System:

Respiratory:

Skin and Appendages:

Special Senses:

Vision:

Urinary System:

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 Amnesteem?

Pregnancy: Category X. See .


What might happen if I take too much Amnesteem?

The oral LD of isotretinoin is greater than 4000 mg/kg in rats and mice (> 600 times the recommended clinical dose of 1 mg/kg/day after normalization of the rat dose for total body surface area and > 300 times the recommended clinical dose of 1 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.

Amnesteem causes serious birth defects at any dosage (see ). 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 . 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 Amnesteem?

Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.]Protect from light.Amnesteem (isotretinoin capsules, USP) contain 10 mg, 20 mg or 40 mg of isotretinoin, USP.The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows:NDC 0378-6611-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows:NDC 0378-6612-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesThe 40 mg capsules are orange-brown and imprinted with I40. They are available as follows:NDC 0378-6614-93Cartons of 30 containing 3 Prescription Packs of 10 capsulesStorage: Store at 68° to 77°F (20° to 25°C). [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 Amnesteem, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.

Non-Clinical Toxicology
Pregnancy: Category X. See .

Amnesteem must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Amnesteem 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 Amnesteem 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).