Soriatane (Acitretin) - Indications and Dosage

Indications and Usage:

Soriatane is indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Soriatane should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Soriatane 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 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. 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 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 is 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 Medication Guide must be given to the patient each time Soriatane is dispensed, as required by law.

How Supplied:

Brown and white capsules, 10 mg, imprinted SORIATANE 10 mg; bottles of 30 (NDC 63032-090-25).

Brown and yellow capsules, 25 mg, imprinted SORIATANE 25 mg; bottles of 30 (NDC 63032-091-25).

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.