Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
ECONAZOLE NITRATE
BRISTOL-MYERS SQUIBB CANADA
D01AC03
ECONAZOLE
1%
CREAM
ECONAZOLE NITRATE 1%
TOPICAL
15G
Prescription
AZOLES
Active ingredient group (AIG) number: 0113163002; AHFS:
CANCELLED POST MARKET
2006-09-05
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 Baca dokumen lengkapnya