Soriatane (Acitretin) - Indications and Dosage

INDICATIONS AND USAGE

SORIATANE Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, SORIATANE Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, SORIATANE 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 — SORIATANE 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

There is intersubject variation in the pharmacokinetics, clinical efficacy and incidence of side effects with SORIATANE 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. SORIATANE Capsules therapy 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 SORIATANE 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.

Information for Pharmacists

A SORIATANE Capsules Medication Guide must be given to the patient each time SORIATANE Capsules are dispensed, as required by law.

HOW SUPPLIED

SORIATANE^® (acitretin) Capsules are supplied as follows:

NDC 0145-3800-01 10 mg CK Covenience Kit containing: SORIATANE^® Capsules 10 mg, bottle of 30 (NDC 63032-090-25) [SORIATANE Capsules are brown and white, imprinted "SORIATANE^® 10 mg" or "acitretin 10 mg",] and VersaFoam-EF™ Emulsion Formulation Moisturizing Foam Net Wt, 3.3 Oz

NDC 0145-4300-01 25 mg CK Covenience Kit containing: SORIATANE^® Capsules 25 mg, bottle of 30 (NDC 63032-091-25) [SORIATANE Capsules are brown and yellow, imprinted "SORIATANE^® 25 mg" or "acitretin 25 mg",] and VersaFoam-EF™ Emulsion Formulation Moisturizing Foam Net Wt, 3.3 Oz

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.