Acitretin 10 MG Oral Capsule

INDICATIONS AND USAGE Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its 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.

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] pain` `[2] drug dependence` `[3] drug ineffective` `[4] overdose` `[5] fatigue` `[6] toxicity to various agents` `[7] death` `[8] emotional distress` `[9] nausea` `[10] headache`

4 years ago

CAPSULE ORANGE MYLAN AC I 02

HOW SUPPLIED

ACITRETIN capsules, USP are available containing 10 mg or 25 mg of

ACITRETIN, USP. The 10 mg capsules are hard shell gelatin capsules with a swedish orange opaque cap and swedish orange opaque body filled with yellow granular powder. The capsules are axially printed with MYLAN over AC I 02 in black ink on the cap and body. They are available as follows: NDC 0378-7020-93 bottles of 30 capsules The 25 mg capsules are hard shell gelatin capsules with a brown opaque cap and yellow opaque body filled with yellow granular powder. The capsules are axially printed with MYLAN over AC I 13 in white ink on the cap and body. They are available as follows: NDC 0378-7023-93 bottles of 30 capsules 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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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Mylan Pharmaceuticals Inc.

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