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Prudoxin

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Since 2009, the Food and Drug Administratio"...

Prudoxin

INDICATIONS

PRUDOXIN (doxepin) Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with the following forms of eczematous dermatitis: atopic dermatitis and lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)

DOSAGE AND ADMINISTRATION

A thin film of PRUDOXIN (doxepin) Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of PRUDOXIN (doxepin) Cream when used for greater than eight days. Chronic use beyond eight days may result in higher systemic levels.

Clinical experience has shown that drowsiness is significantly more common in patients applying PRUDOXIN (doxepin) Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug.

Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings with PRUDOXIN (doxepin) Cream should not be utilized.

HOW SUPPLIED

PRUDOXIN (doxepin) Cream is available in a 45 g (NDC 0064-3600-45) aluminum tube. Store at or below 27° C (80° F).

HEALTH POINT® 1-800-441-8227. www.healthpoint.com. FDA Rev date: n/a

Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.

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