Drug Catalog - Product Detail
ACITRETIN 10MG CAP 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-7020-93 | MYLAN | 30 | 10MG | CAPSULE |
PACKAGE FILES
Generic Name
ACITRETIN
Substance Name
ACITRETIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202148
Description
DESCRIPTION Acitretin capsules, USP (acitretin), a retinoid, are available in 10-mg or 25-mg gelatin capsules for oral administration. Chemically, acitretin, USP is ( all-E )-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow or greenish crystalline powder with a molecular weight of 326.44. The structural formula is: Each capsule contains acitretin, edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide. The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Acitretin structural formula
How Supplied
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.
Indications & Usage
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.
Dosage and Administration
DOSAGE AND ADMINISTRATION There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with acitretin 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. Therapy with acitretin capsules 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 acitretin 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. TEGISON is no longer marketed in the U.S.; for information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). Information for Pharmacists Acitretin capsules must only be dispensed in no more than a monthly supply. An acitretin capsules Medication Guide must be given to the patient each time acitretin capsules are dispensed, as required by law.