ZONALON CREAM 5%

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXEPIN HYDROCHLORIDE

Available from:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

ATC code:

D04AX

INN (International Name):

OTHER ANTIPRURITICS

Dosage:

5%

Pharmaceutical form:

CREAM

Composition:

DOXEPIN HYDROCHLORIDE 5%

Administration route:

TOPICAL

Units in package:

30G

Prescription type:

Prescription

Therapeutic area:

ANTIPRURITICS AND LOCAL ANESTHETICS

Product summary:

Active ingredient group (AIG) number: 0131283007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-07-08

Summary of Product characteristics

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