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DOSAGE AND ADMINISTRATION
A thin film of Zonalon (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 Zonalon (doxepin) Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Zonalon (doxepin) cream for longer than 8 days may result in an increased likelihood of contact sensitization.
The risk for sedation may increase with greater body surface area application of Zonalon cream (See WARNINGS section). Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon (doxepin) Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area (see WARNINGS section) 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.
Zonalon (doxepin) Cream is available in 30 g (NDC 62436-523-30) and 45 g (NDC 62436-523-45) tubes. Store at or below 27° C (80° F).
Manufactured for: Bioglan Pharma, Inc. Malvern, PA 19355 by: DPT Laboratories, Inc. San Antonio, Texas 78215. FDA Rev date: 12/20/2002
Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.
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