Recommended Topic Related To:

Prudoxin

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

Prudoxin

WARNINGS

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.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, mutagenesis, impairment of fertility studies have not been conducted with doxepin hydrochloride.

Pregnancy

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.

Nursing Mothers

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.

One case has been reported of apnea and drowsiness in a nursing infant whose mother was taking an oral dosage form of doxepin HCI.

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.

Pediatric Use

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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