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Drug Catalog - Product Detail

ACITRETIN CP 10MG 30

NDC Mfr Size Str Form
66993-0894-30 PRASCO LABORATORIES 30 10MG CAPSULE
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Description
DESCRIPTION Acitretin Capsules (acitretin), a retinoid, are available in 10-mg and 25-mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is: Each capsule contains acitretin, black monogramming ink, gelatin, maltodextrin (a mixture of polysaccharides), microcrystalline cellulose, and sodium ascorbate. Gelatin capsule shells contain gelatin, iron oxide (yellow, black, and red), and titanium dioxide. They may also contain benzyl alcohol, carboxymethylcellulose sodium, edetate calcium disodium. acitretin chemical structure
How Supplied
HOW SUPPLIED: Brown and white capsules, 10 mg, imprinted “A-10 mg”; bottles of 30 (NDC 66993-894-30). Brown and yellow capsules, 25 mg, imprinted “A-25 mg”; bottles of 30 (NDC 66993-896-30). Store between 15° and 25°C (59° and 77°F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.
Indications & Usage
INDICATIONS AND USAGE Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with their use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS —Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.
Dosage and Administration
DOSAGE AND ADMINISTRATION There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with Acitretin Capsules. A number of the more common side effects are dose-related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Therapy with Acitretin Capsules should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient’s response to initial treatment. Relapses may be treated as outlined for initial therapy. When Acitretin Capsules are used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient’s individual response (see PRECAUTIONS : General). Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call Stiefel at 1-888-784-3335 (1-888-STIEFEL). Information for Pharmacists: Acitretin Capsules must only be dispensed in no more than a monthly supply. An Acitretin Capsules Medication Guide must be given to the patient each time Acitretin Capsules are dispensed, as required by law.