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Drug Name:


Generic Name and Formulations:
Isotretinoin 10mg, 20mg, 40mg; caps; contains soy.

Mylan Inc.

Therapeutic Use:

Indications for AMNESTEEM:

Severe recalcitrant nodular acne unresponsive to conventional therapy (eg, systemic antibiotics).


Take with meals. 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. Repeat course only if necessary after at least 2 months drug-free interval.


Not recommended.


Pregnancy (Cat.X). Nursing mothers.


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 literature). Monitor blood lipids initially and for 1st 4 weeks. History of psychiatric disorders; monitor and discontinue if signs and symptoms develop. Osteoporosis risk (eg, osteomalacia, anorexia nervosa) or risk of metabolic bone disorders. Monitor bone growth, glucose, sed rate, CBC, liver enzymes. Discontinue if visual or auditory disturbances; colitis, pancreatitis or hepatitis symptoms; uncontrolled hypertriglyceridemia, or significant decrease in WBCs occurs. Refer to specialist if papilledema or hearing disturbances occur. Do not donate blood during and for 1 month after therapy. Avoid wax epilation or skin resurfacing during and for 6 months after therapy. Adolescents. Avoid sun, UV light. Reduced tolerance to contact lenses. Max 1/℞.


Avoid tetracyclines (increased risk of pseudotumor cerebri), Vit. A, or alcohol consumption. Avoid St. John's wort with hormonal contraceptives. Low-dose progestin-only contraceptives (ie, minipills) may provide inadequate contraception. Caution with drugs that can disturb bone metabolism (eg, anticonvulsants, systemic corticosteroids).

Pharmacological Class:


Adverse Reactions:

Dry skin, eyes, nose, mouth, and lips, transient exacerbation of acne, dizziness, drowsiness, headache, abnormal menses, bronchospasm, voice changes, alopecia, epistaxis, flushing, hirsutism, rash, GI disturbances, photosensitivity, abnormal wound healing, depression, psychosis, suicidal ideation, aggression, pseudotumor cerebri, pancreatitis; visual, auditory, or lipid disturbances; hepatotoxicity, glomerulonephritis, inflammatory bowel disease, osteopenia, osteoporosis, hyperostosis, premature epiphyseal closure, reversible corneal opacities, decreased night vision, musculoskeletal symptoms, back/chest pain, blood dyscrasias, glucose intolerance, palpitation, thrombotic disease.



Generic Availability:


How Supplied:

Caps 10mg, 20mg—3 x 10 ℞ packs; 40mg—3 x 10, 10 x 10 ℞ packs

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