Generic Name and Formulations:
Acitretin 10mg, 17.5mg, 25mg; caps.
Stiefel Laboratories, Inc.
Indications for SORIATANE:
Severe psoriasis (in female patients of reproductive potential, use only if unresponsive to or cannot take other agents).
25–50mg once daily with main meal; may discontinue when lesions resolve. May repeat if relapse occurs. Prescribe limited supply. Decrease phototherapy dose.
Alcohol. Concomitant methotrexate, tetracyclines. Severe hepatic or renal impairment. Dyslipidemias. Pregnancy (Cat.X). Retinoid hypersensitivity.
Pregnancy. Important information for women of childbearing potential and for males taking Soriatane. Medication guide must be given to all patients. Hepatotoxicity.
Be fully familiar with toxicity and teratogenicity before use. Transient worsening of symptoms may occur. Females of reproductive potential (including history of infertility): obtain 2 reliable (–) pregnancy tests (when decision is made to start and during first 5 days of menstrual period prior to treatment initiation) and repeat periodically (eg, monthly); use at least 2 reliable methods of contraception or abstain for at least 1 month before, during, and for 3 years after therapy (if etretinate had been used previously, continue to follow contraception recommendations for that product). Discontinue if hepatotoxicity is suspected, if papilledema (refer to neurologist), visual difficulties (refer to ophthalmologist), psychiatric symptoms (eg, depression), capillary leak syndrome, or exfoliative dermatitis/erythroderma occurs. Monitor for ossification abnormalities. Do pretreatment blood lipid evaluation and repeat at 1–2 week intervals until lipid response established; control significant triglyceride elevations with diet, drugs, or dose reduction; consider discontinuing if hypertriglyceridemia and low HDL levels persist. Perform LFTs prior to initiation, at 1–2 week intervals until stable, and thereafter as clinically indicated. Avoid sun and UV light. Monitor diabetics. Do not donate blood during and for 3 years after therapy. Get written informed consent. Elderly. Nursing mothers: not recommended.
See Contraindications (methotrexate increases risk of hepatitis; tetracycline increases intracranial pressure). Females must not ingest ethanol during or for 2 months after therapy (prolongs teratogenic potential). Microdosed "minipill" progestin preparations: not recommended. May interfere with other progestin-only contraceptives (eg, injectables, implants). Avoid St. John's wort, others that may decrease efficacy of contraceptives, vitamin A, other oral retinoids. May potentiate phenytoin, sulfonylureas.
Lipid elevations, abnormal LFTs and other lab tests, cardiovascular effects, psychiatric symptoms, chelitis, alopecia, skin peeling, dry or sticky skin, nail disorder, pruritus, dry mouth, rhinitis, hypervitaminosis A syndrome, epistaxis, rash, hyperesthesia, paresthesia, xerophthalmia, dry or irritated eye, loss of eye brow or lashes, decreased night vision, intolerance to contact lenses, arthralgia, spinal hyperostosis, rigors; rare: pseudotumor cerebri, pancreatitis, hepatitis.
Call (888) 784-3335 or visit www.soriatane.com for information on the Do Your P.A.R.T. program.