Acitretin

SORIATANE (acitretin) is indicated for: • Severe psoriasis (includes erythrodermic and pustular types) • Other disorders of keratinization Severe psoriasis is a condition that involves more than 10% of body surface area or is physically, occupationally or psychologically disabling.

Because of significant adverse effects associated with its use, SORIATANE should be reserved for patients with the diseases listed above when these are unresponsive to or intolerant of standard treatment. SORIATANE should only be prescribed by physicians knowledgeable and experienced in the use of systemic retinoids and who understand the risk of teratogenicity associated with SORIATANE treatment (see

• Severe extensive psoriasis which is resistant to other forms of therapy. • Palmo-plantar pustular psoriasis. • Severe congenital ichthyosis. • Severe Darier’s disease (keratosis follicularis).

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.