"The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) cau"...
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.
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/aThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/21/2008
Additional Prudoxin Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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