TIAMOL CREAM 0.05%

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUOCINONIDE

Available from:

TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.

ATC code:

D07AC08

INN (International Name):

FLUOCINONIDE

Dosage:

0.05%

Pharmaceutical form:

CREAM

Composition:

FLUOCINONIDE 0.05%

Administration route:

TOPICAL

Units in package:

100G/25G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0106313001; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-09-05

Summary of Product characteristics

PRESCRIBING INFORMATION
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_TIAMOL_
_®_
(Fluocinonide Cream, USP) Emollient Base
Topical Corticosteroid
TaroPharma, A Division of Taro Pharmaceuticals Inc.
Date of Preparation:
130 East Drive
September 23, 2003
Brampton, Ontario, Canada
L6T 1C1
Control#: 085797
_TIAMOL_
_®_
(Fluocinonide Cream, USP) Emollient Base
Topical Corticosteroid
PHARMACOLOGY
Fluocinonide is effective because of the anti-inflammatory,
antipruritic and vasoconstrictor
actions of fluocinonide.
INDICATIONS
For topical use in the management of acute or chronic dermatoses
responsive to corticosteroids.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in tuberculosis, fungal,
most viral lesions of the skin
(including herpes simplex, vaccinia and varicella), untreated
bacterial infections and also
contraindicated in individuals with a history of hypersensitivity to
its components. This
preparation is not for ophthalmic use.
WARNINGS
Adrenal suppression and other systemic effects may occur after
applications to extensive areas
and prolonged usage. Fluocinonide should not be used under occlusive
dressings. Not for
ophthalmic use.
Dilution of a physical topical, commercially formulated corticosteroid
preparation may result in
a physical incompatibility or an unstability of the active
ingredients. Manipulation of the
preparation may cause bacterial contamination or alter the release of
active ingredients from the
base.
_Pregnancy and Lactation: _The safety of topical corticosteroid
preparations during pregnancy
and lactation has not been established; therefore, they should not be
used on pregnant patients.
PRECAUTIONS
Although side effects are not ordinarily encountered with topically
applied corticosteroids, as
with all drugs, a few patients may react unfavorably under certain
conditions. Should symptoms
of hypersensitivity or idiosyncrasy occur, the medication should be
discontinued and appropriate
steps taken.
If the lesion is infected the use of an appropriate antifungal or
antibacterial agent should be
institu