Roacta

Severe recalcitrant nodular acne unresponsive to conventional therapy.

Very severe disease/scarring or primarily involves the trunk Adult May adjust up to 2 mg/kg daily. May initiate 2nd course of therapy after ≥2 mth. Severe recalcitrant nodular acne Adult & childn 12-17 yr 0.5-1 mg/kg daily in 2 divided doses for 15-20 wk or until total cyst count decreases by 70% whichever is sooner.

Should be taken with food.

Hypersensitivity to isotretinoin, parabens, vit A or other retinoid. Pregnancy.

Hypersensitivity. Discontinue treatment if depression, psychosis, aggressive or violent behavior & changes in mood occur; in patients w/ papilledema, headache, nausea, vomiting & visual disturbances; hearing impairment. Not to donate blood during & for 1 mth following discontinuation of therapy due to risk of donated blood being given to pregnant female. Patients w/ psychiatric disorders; DM; hypertriglyceridemia; genetic predisposition to bone disorders & w/ disease states; hypervitaminosis A or hyperlipidemia. Pseudotumor cerebri (benign intracranial HTN); clinical hepatitis, elevated liver enzymes, inflammatory bowel disease, skeletal hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities & decreased night vision. Avoid in concomitant use w/ tetracycline. Concomitant use w/ medications inducing bone disorders. Patients w/ liver, kidney disease. Begin therapy after 2 -ve pregnancy tests & women of childbearing potential must use at least 2 forms of effective contraception for at least 1 mth before & during therapy & 1 mth after discontinuation of therapy. Women who are likely to become pregnant. Repeat pregnancy testing & counseling mthly. Do not use in pregnancy. Lactation. Not recommended for childn <12 yr. Low IQ scores in surviving infants.

Chest pain, edema, flushing, palpitation, stroke, syncope, tachycardia, vascular thrombotic disease; aggressive behavior, depression, dizziness, drowsiness, emotional instability, fatigue, headache, insomnia, lethargy, malaise, nervousness, paresthesia, pseudotumor cerebri, psychosis, seizure, stroke, suicidal ideation & attempts, suicide & violent behavior; abnormal wound healing, acne fulminans, alopecia, bruising, cheilitis, dry nose & skin, eczema, eruptive xanthomas, facial erythema, skin fragility, hirsutism, hyper- & hypopigmentation, increased sunburn susceptibility, nail dystrophy, paronychia, peeling of palms & soles, photoallergic & photosensitizing reactions, pruritus, purpura, rash; increased triglycerides (25%), blood glucose & cholesterol, abnormal menses, decreased HDL, hyperuricemia; gums bleeding & inflammation, colitis, esophagitis, esophageal ulceration, inflammatory bowel disease, nausea, non-specific GI symptoms, pancreatitis, wt loss, xerostomia; non-specific urogenital findings; anemia, neutropenia, pyogenic granuloma, thrombocytopenia; increased alkaline phosphatase, ALT, AST, γ-glutamyl transpeptidase & LDH, hepatitis; back pain (29% in ped patients), arthralgia, arthritis, bone abnormalities, decreased bone mineral density, calcification of tendons & ligaments, increased CPK, myalgia, premature epiphyseal closure, skeletal hyperostosis, tendonitis, weakness; cataracts, color vision disorder, conjunctivitis, corneal opacities, dry eyes, eyelid, inflammation, keratitis, decreased night vision, optic neuritis, photophobia, visual disturbances; hearing impairment, tinnitus; glomerulonephritis, hematuria, proteinuria, pyuria, vasculitis; bronchospasm, epistaxis, resp infection, voice alteration, Wegener's granulomatosis; allergic & anaphylactic reactions, disseminated herpes simplex, diaphoresis, infection, lymphadenopathy.

Increased levels/effects of vit A. Increased levels/effects w/ ethyl alcohol, tetracycline derivatives. Decreased levels/effects of estrogens & progestins. May increase triglyceride levels w/ ethanol. Increased bioavailability w/ food or milk. Dong quai, St. John's wort.

Acne Treatment Preparations

D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.

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