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Tel: 01-737-8991; 01-871-3181; 0803-343-1338; 0803-569-9324
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Vaginal pessary (NRN: 04-6748): Each pessary contains Clotrimazole BP 100 mg in a special water soluble base.
Pack size: In a strip of 7 Vaginal pessaries.
Imazole-V contains Clotrimazole, a new generation imidazole derivative possessing a potent and broad spectrum antifungal, anticandidal and antitrichomonal activity. In vitro, depending on the concentration, Clotrimazole exhibits fungistatic or fungicidal activity against a wide range of isolates of Dermatophytes e.g. Trichophyton rubrum, Trichophyton mentagrophyte, Epidermatophyton floccosum. Clotrimazole exhibits a high degree of anticandidal action on pathogenic strains of Candida e.g. Candida albicans; it also shows a good antimicrobial action on Malassezia furfur. Strains of fungi having a natural resistance to Clotrimazole are rare.
No single step or multiple step resistance to Clotrimazole has developed during successive passages of Candida albicans.
Clotrimazole is known to possess antitrichomonal and antibacterial activity particularly against some of the gram positive organisms. Clotrimazole causes alteration in the cell wall permeability and leads to leakage of intracellular phosphorus compounds with concomitant breakdown of cellular nucleic acid and accelerated potassium influx. These rapidly and extensively developing changes contribute to fungicidal activity of Clotrimazole.
Following the topical or vaginal administration, clotrimazole appears to be minimally absorbed.
Infective vaginitis caused by organisms susceptible to clotrimazole: Vulvovaginal candidiasis (moniliasis); Trichomonal vaginitis; Mixed vaginitis.
Prophylaxis of candidal overgrowth in diabetes mellitus, pregnancy, use of broad spectrum antibiotics.
History of hypersensitivity to Clotrimazole or similar imidazole derivatives.
Use in Pregnancy:
Due to lack of data, the use of Imazole-V, during first trimester should be avoided, if possible. However, use of Clotrimazole in second and third trimesters of pregnancy appears to be not associated with ill effects.
Considering that candidosis is common in late pregnancy period, and Imazole-V is non-systematic in action, Imazole-V may be used in the last weeks of pregnancy if thought to be beneficial.
Imazole-V is usually well tolerated when used in the recommended dose. As Clotrimazole is not absorbed through the vaginal mucosa, Imazole-V is unlikely to produce any systematic side effects.
Occasionally, Imazole-V may lead to local side effects e.g. burning or irritation. These symptoms usually tend to subside and need no withdrawal of the therapy. However, if irritation or burning is of severe nature or persists, then it is advisable to discontinue the treatment.
Imazole-V pessaries being colourless do not stain the underwear.
Dosage & Administration
The usual recommended dose of Imazole-V is one pessary to be inserted deep into the vagina, preferably when lying on the back for seven consecutive nights before retiring.
In case of a refractory or recurring infection the dose and/or duration may be doubled.
For better results, the treatment should be commenced after menstruation or completed before the start of menstruation.