Generic Name and Formulations:
Isotretinoin 10mg, 20mg, 25mg+, 30mg, 35mg, 40mg; caps; contains soy, + tartrazine.
Ranbaxy Pharmaceuticals, Inc.
Severe recalcitrant nodular acne unresponsive to conventional therapy (eg, systemic antibiotics).
Do not initiate second course of therapy (only if necessary) until ≥8 weeks after completing first course.
Swallow caps with a full glass of liquid. 0.5–1mg/kg per day in 2 divided doses; treat for 15–20 weeks or less if nodule count reduced by >70%; max 2mg/kg per day.
Do not substitute with other forms of isotretinoin. Must register patient in iPLEDGE program (see full labeling for restrictions and stipulations on use). Be fully familiar with drug's toxicity before use. Counsel patient about need for contraception; obtain 2 negative pregnancy tests prior to initiation of drug and monthly thereafter; use 2 effective methods of contraception 1 month before, during, and 1 month after therapy; get written informed consent (see full labeling). Monitor blood lipids initially and weekly or biweekly for 1st 4 weeks. History of psychiatric disorders; monitor and discontinue if signs and symptoms develop. Discontinue and refer to specialist if papilledema or hearing disturbances occur. Discontinue if visual difficulties, severe skin reactions (eg, SJS, TEN), pancreatitis or hepatitis symptoms, abdominal pain, rectal bleeding, severe diarrhea, or uncontrolled hypertriglyceridemia occur. Osteoporosis risk (eg, osteomalacia, anorexia nervosa) or risk of metabolic bone disorders. Monitor bone growth, glucose, sed rate, CBCs, LFTs (weekly or biweekly). Do not donate blood during and for 1 month after therapy. Aspirin hypersensitivity. Reduced tolerance to contact lenses. Max 1/℞. Nursing mothers: not recommended.
Avoid tetracyclines (increased risk of pseudotumor cerebri), Vit. A, or alcohol consumption (for ≥36hrs before lipid test). Caution with concomitant phenytoin. Avoid St. John's wort with hormonal contraceptives. Low-dose progestin-only contraceptives (eg, minipills) may provide inadequate contraception. Caution with drugs that can disturb bone metabolism (eg, anticonvulsants, systemic corticosteroids).
Dry lips, skin, and eyes, back pain, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, blood creatinine kinase increased, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, visual acuity reduced; auditory or lipid disturbances, skin reactions, pancreatitis, pseudotumor cerebri, hepatotoxicity, inflammatory bowel disease, psychiatric disorders, osteopenia, osteoporosis, hyperostosis, premature epiphyseal closure, reversible corneal opacities, decreased night vision, blood dyscrasias, glucose intolerance, palpitation, thrombotic disease.
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