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Drowsiness occurs in over 20% of patients treated with Doxepin HCl Cream 5%, especially in patients receiving treatment to greater than 10% of their body surface area. Patients should be warned of this possibility and cautioned against driving a motor vehicle or operating hazardous machinery while being treated with PRUDOXIN (doxepin) Cream. Patients should also be warned that the effects of alcoholic beverages can be potentiated when using PRUDOXIN (doxepin) Cream. If excessive drowsiness occurs it may be necessary to reduce the number of applications, the amount of cream applied, and/or the percentage of body surface area treated, or discontinue the drug.
Keep this product away from the eyes.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis, mutagenesis, impairment of fertility studies have not been conducted with doxepin hydrochloride.
Pregnancy Category B: Teratology studies have been performed in rats and rabbits at oral doses up to 8 times the topical human dose (based on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to the fetus due to doxepin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Doxepin is excreted in human milk after oral administration. There have been no studies conducted to date to determine if doxepin is excreted in human milk after topical administration; however, it is known that significant systemic levels of doxepin are obtained after topical administration. It is therefore possible that doxepin could be secreted in human milk following topical administration.
Because of the potential for serious adverse reactions in nursing infants from doxepin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of PRUDOXIN (doxepin) Cream in children have not been established.
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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