ECOSTATIN CREAM 1%

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ECONAZOLE NITRATE

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

D01AC03

INN (International Name):

ECONAZOLE

Dosage:

1%

Pharmaceutical form:

CREAM

Composition:

ECONAZOLE NITRATE 1%

Administration route:

TOPICAL

Units in package:

15G

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0113163002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2006-09-05

Summary of Product characteristics

PRODUCT MONOGRAPH
ECOSTATIN*
(ECONAZOLE NITRATE)
TOPICAL CREAM; 1%
VAGINAL OVULES; 150 MG
ANTIFUNGAL AGENT
Bristol-Myers Squibb Canada
2365 Cote de Liesse
Date of Preparation:
Montreal, Canada.
November 9, 2004
H4N 2M7
Date of Revision:
*
TM of Bristol-Myers Squibb Canada
Control No.: 095094
1
PRODUCT MONOGRAPH
ECOSTATIN*
(ECONAZOLE NITRATE)
Topical Cream; 1%
Vaginal Ovules; 150 mg
THERAPEUTIC CLASSIFICATION
Antifungal Agent
ACTION AND CLINICAL PHARMACOLOGY
Econazole nitrate exhibits antifungal activity against a wide variety
of fungi, including
dermatophytes, pathogenic yeasts, and moulds. Susceptible pathogenic
organisms include
_Candida albicans_ and other _Candida_ species, _Trichophyton rubrum_,
_Trichophyton_
_mentagrophytes_, _Epidermophyton floccosum_, and _Malassezia furfur_.
It appears to act by
altering the internal structure or cell membrane permeability of the
fungus.
INDICATIONS
ECOSTATIN (econazole nitrate) Topical Cream is indicated for the
treatment of infections
caused by susceptible dermatophyte and _candida_ species including
_tinea pedis_, _tinea cruris_,
_tinea corporis_, _tinea versicolor_ and cutaneous candidiasis. It is
not indicated for moderate or
severe paronychia or onychomycosis.
ECOSTATIN Vaginal Ovules are indicated for the local treatment of
vulvovaginal candidiasis
(moniliasis).
CONTRAINDICATIONS
Hypersensitivity to econazole nitrate or any of the cream's or ovule's
components.
ECOSTATIN Topical cream should not be used in or around the eyes.
PRECAUTIONS
If marked irritation or sensitization should occur during topical use
or intravaginal use,
discontinue ECOSTATIN (econazole nitrate) therapy.
Intractable candidiasis may be the presenting symptom of unrecognized
diabetes. Appropriate
urine/blood studies may be indicated in patients not responding to the
treatment.
During treatment with ECOSTATIN Vaginal ovule, it may be advisable to
instruct the patient to
abstain from intercourse or alternatively, to recommend the use of a
condom.
PREGNANCY: Since econazole nitrate is absorbed i