Applies to the following strength(s): 10 mg ; 40 mg ; 20 mg ; 30 mg ; 25 mg ; 35 mg
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Acne
Severe recalcitrant nodular acne: 0.5 to 1 mg/kg/day orally in 2 divided doses; patients whose disease is very severe with scarring or is primarily manifested on the trunk may require up to 2 mg/kg/day
Usual Adult Dose for Melanoma - Metastatic
Combination therapy with interferon alfa: 60 mg/day, divided in 3 equal doses, for 6 months
Usual Adult Dose for Granuloma Annulare
0.5 to 1 mg/kg/day orally in equally divided doses twice a day
Usual Pediatric Dose for Acne
Severe recalcitrant nodular acne:
12 years or older: 0.5 to 1 mg/kg/day orally in 2 divided doses
Usual Pediatric Dose for Acute Nonlymphocytic Leukemia
Pediatric Oncology Group Study (n=41)
1 month or older: 100 mg/m2/day orally, given as a single dose, for 4 weeks
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Dosage reduction is recommended in drug-related liver function test elevations.
The dose may be adjusted during therapy according to disease response and/or side effects (some may be dose related). Since failure to take isotretinoin with food will significantly decrease absorption, patient compliance with food instructions should be determined before increasing dosages.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin. It includes a medication guide, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/REMS.
Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. The birth defects documented following exposure to isotretinoin include abnormalities of the face, eyes, ears, skull, central nervous system (CNS), cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. In some cases death has occurred with some of the abnormalities previously mentioned. If pregnancy occurs during the course of treatment of a female, the drug must be discontinued immediately and she should be referred to an obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Because of the high teratogenicity of isotretinoin and to minimize fetal exposure, isotretinoin is available only through a special restricted distribution program called iPLEDGE (TM). Prescribers, pharmacies, and wholesalers must be registered and activated with the iPLEDGE program in order to prescribe, dispense, or distribute isotretinoin. Isotretinoin must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. This registration process ensures that prescribers, pharmacists, and patients agree to assume specific responsibilities to ensure that patients do not become pregnant while taking isotretinoin and do not get prescribed the medicine if they are pregnant. Further details on iPLEDGE are available at www.ipledgeprogram.com or by calling 1-866-495-0654 (USA).
Women of reproductive potential must not be given a prescription until pregnancy is excluded. The use of isotretinoin is contraindicated in females of reproductive potential unless the patient meets all the requirements of the iPLEDGE program.
Isotretinoin may cause depression, psychoses, and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. Prior to initiation of 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 is warranted. Patients should stop isotretinoin and promptly contact their prescriber, without waiting until the next visit, if the patient develops depression, mood disturbance, psychosis, or aggression.
Pseudotumor cerebri (benign intracranial hypertension) has been associated with the use of isotretinoin. Some of the cases involved concomitant use of tetracyclines; therefore, tetracyclines should be avoided while receiving isotretinoin. Early signs and symptoms include papilledema, headache, nausea and vomiting, and visual disturbances. If these symptoms appear on a patient, the drug should be discontinued immediately and the patient should be referred to a neurologist for further diagnosis and care.
Isotretinoin soft gelatin capsules should not be given to patients who are sensitive to parabens (used as preservatives).
Anaphylactic and other allergic reactions have been reported with isotretinoin. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura of the extremities and extracutaneous involvement (including renal) have been reported. If a severe allergic reaction occurs, isotretinoin should be discontinued and appropriate medical management is recommended.
Erythema multiforme and severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been associated with isotretinoin during postmarketing experience. Such reactions may be serious and result in death, life-threatening events, hospitalization, or disability. Close monitoring is recommended and isotretinoin should be discontinued if significant skin reactions occur.
Neutropenia and rare cases of agranulocytosis have been reported. Discontinuation of isotretinoin is recommended if clinically significant decreases in white cell counts occur.
Acute pancreatitis has been reported in patients with elevated or normal serum triglyceride levels. Isotretinoin is known to cause elevations in serum triglycerides. In rare cases, fatal hemorrhagic pancreatitis has been reported. Therapy should be discontinued if hypertriglyceridemia cannot be controlled or symptoms of pancreatitis occur.
Blood lipid measurements should be performed before isotretinoin is given and then at weekly or biweekly intervals until the lipid response to the drug is established, which usually occurs within 4 weeks. Patients at risk for developing extreme elevations include those with diabetes mellitus, obesity, high alcohol consumption, lipid metabolism disorder or familial history of lipid metabolism disorder. If isotretinoin is initiated in such patients, more frequent checks of lipids and/or blood sugar levels are recommended.
Some patients receiving isotretinoin have experienced problems with blood sugar control; therefore, blood sugar levels should be monitored carefully in diabetics.
Spontaneous reports of osteoporosis, osteopenia, bone fractures, premature epiphyseal closure, and delayed healing of bone fractures have been seen in the isotretinoin population. While causality to isotretinoin has not been established, an effect cannot be ruled out. Longer term effects have not been studied. Caution is recommended when using isotretinoin in patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. It is important that isotretinoin be given at the recommended doses for no longer than the recommended duration. 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.
In a clinical trial, musculoskeletal symptoms (including arthralgia) developed during treatment. The symptoms were generally mild to moderate, but drug discontinuation was necessary on occasion. Transient chest pain has been reported less frequently. During the clinical trial, these symptoms usually cleared rapidly following isotretinoin discontinuation, but persisted in some cases. Rhabdomyolysis (associated with strenuous physical activity in some cases) has been reported rarely during postmarketing experience.
Impaired hearing has been reported which has persisted after discontinuation of therapy. Patients experiencing tinnitus or hearing impairment should discontinue isotretinoin and be referred to a specialist for further evaluation.
Clinical hepatitis possibly or probably associated with isotretinoin has been reported. During clinical trials, mild to moderate elevations in liver enzymes have been observed, some of which normalized with dose reduction or continued administration. Pretreatment and follow-up liver function tests are recommended weekly or biweekly until the response to isotretinoin has been determined. If hepatitis is suspected or elevated liver enzymes persist, isotretinoin should be discontinued and the etiology further investigated.
Inflammatory bowel disease (including regional ileitis) has been associated with the use of isotretinoin in patients without a history of intestinal disorder. In some cases, symptoms have persisted after discontinuation of therapy. Patients experiencing abdominal pain, rectal bleeding, or severe diarrhea should discontinue isotretinoin immediately.
Visual problems should be carefully monitored. All patients experiencing visual difficulties should discontinue isotretinoin and have an ophthalmological examination. Corneal opacities have been reported in patients receiving isotretinoin, more frequently when higher doses were used in patients with disorders of keratinization. The corneal opacities reported in clinical trials had either resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug.
Decreased night vision, in some instances sudden, has been reported during isotretinoin therapy. In some cases, the event has persisted after therapy was discontinued. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.
Patients should be advised that they must not give their isotretinoin to any other person.
The prescription must be filled and picked up within 7 days of the date of specimen collection for the pregnancy test for female patients of childbearing potential and within 30 days of the office visit for male patients and female patients not of childbearing potential.
Safety and efficacy have not been established in pediatric patients less than 12 years of age.
Very small amounts of the drug are eliminated renally.
Therapy is usually continued for 15 to 20 weeks. Therapy may be discontinued sooner if the total number of cysts or nodules has been reduced by more than 70%. After at least 2 months off of therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated.
Isotretinoin should be taken with food. The capsules should be swallowed with a full glass of liquid to decrease the risk of esophageal irritation.