Acitretin

Indications

INDICATIONS AND USAGE Acitretin Capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules, USP 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, USP 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 (summary)

DOSAGE AND ADMINISTRATION There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with Acitretin Capsules, USP. 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, USP 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.

Contraindications

CONTRAINDICATIONS Pregnancy Category X: ( see boxed CONTRAINDICATIONS AND WARNINGS . ) Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS: Hepatotoxicity , WARNINGS: Lipids and Possible Cardiovascular Effects , and PRECAUTIONS ). An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate.

Warnings and precautions

WARNINGS ( See also boxed CONTRAINDICATIONS AND WARNINGS .) Hepatotoxicity: Of the 525 subjects treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with acitretin. Liver function test results in these subjects returned to normal after acitretin was discontinued. Two of the 1,289 subjects treated in European clinical trials developed biopsy-confirmed toxic hepatitis. A second biopsy in one of these subjects revealed nodule formation suggestive of cirrhosis.

Pregnancy

Pregnancy:

Storage and supply

HOW SUPPLIED: Acitretin Capsules, USP 10 mg (opaque yellow and opaque white) are imprinted “Σ 80” on body and cap; Bottles of 30 (NDC 72162-2222-3). Store at 20 to 25°C (68 to 77°F). See USP Controlled Room Temperature. Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

Source: Acitretin (Acitretin) — US FDA prescribing information, 2024-01-26, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.