Land: Canada
Taal: Engels
Bron: Health Canada
DOXEPIN HYDROCHLORIDE
VALEANT CANADA LP / VALEANT CANADA S.E.C.
D04AX
OTHER ANTIPRURITICS
5%
CREAM
DOXEPIN HYDROCHLORIDE 5%
TOPICAL
30G
Prescription
ANTIPRURITICS AND LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0131283007; AHFS:
CANCELLED POST MARKET
2016-07-08
PRODUCT MONOGRAPH ZONALON CREAM 5% GENERIC NAME DOXEPIN HYDROCHLORIDE CREAM 5% THERAPEUTIC CLASSIFICATION TOPICAL ANTIPRURITIC Valeant Canada LP. Date of Preparation: Montreal, Quebec March 19, 2013 H4R 2P9 Control Number: 162602 1 PRODUCT MONOGRAPH PROPER NAME: ZONALON CREAM (DOXEPIN HCL CREAM 5%) THERAPEUTIC CLASSIFICATION: TOPICAL ANTIPRURITIC 2 ACTION Doxepin, a dibenzoxepin-derivative tricyclic compound, is a topical antipruritic. While the exact mechanism of antipruritic activity is unknown, Doxepin exhibits potent histamine H1 and H2 receptor antagonist activity. Although the sedative effect of systemically absorbed Doxepin may contribute to the drug's antipruritic activity, the antipruritic efficacy of Doxepin reportedly does not appear to depend on a sedative effect. INDICATIONS ZONALON Cream 5% (Doxepin HCL Cream) is indicated for the short term (up to 8 days) topical relief of histamine mediated pruritus of moderate severity accompanying conditions such as eczematous dermatitis. CONTRAINDICATIONS ZONALON Cream is contraindicated in individuals who have shown hypersensitivity to the drug or to other dibenzoxepin compounds. ZONALON Cream is not recommended in children under the age of 12 because safety and efficacy in this age group have not been established. Because Doxepin HC1 has an anticholinergic affect and because significant plasma levels of Doxepin are detectable after topical ZONALON CREAM application, the use of ZONALON CREAM is contraindicated in patients with glaucoma or a tendency to urinary retention. ZONALON CREAM is contraindicated in individuals who have shown previous sensitivity to any of its components. 3 WARNINGS PREGNANCY AND LACTATION: The safety of ZONALON Cream during pregnancy and lactation has not been established and therefore, it should not be used in women of child bearing potential or nursing mothers unless in the opinion of the physician, the potential benefit to the patient outweighs the possible hazards to the fetus. Drowsiness occurs in over 20% of patients treated with Lees het volledige document