Sertaconazole Nitrate [Vaginal]

Sertaconazole is an imidazole derivative and is a preparation that destroys fungi. The preparation is used in the local treatment of vaginal candidiasis.

Sertaconazole is a new topical broad-spectrum antifungal. It acts against pathogenic yeasts (Candida albicans, C. tropicalis, C. spp. Pityrosporum orbiculare), dermatophytes (Trichophyton, Epidermophyton and Microsporum) and gram-positive bacteria (Staphylococcus and Streptococcus).

One vaginal suppository in the evening, to be inserted deeply into the vagina, preferably while lying down. If symptoms persist, repeat with a second vaginal suppository 7 days after the first administration.

The concomitant use with contraceptive diaphragm may cause the sheath or diaphragm to break during the insertion of the vaginal suppository (See Contraindications). The concomitant use with local spermicidal contraception is not recommended as the spermicide may be inactivated.

Known hypersensitivity to any imidazole antimycotic or to any of the excipients. Concomitant use of contraceptive diaphragm.

With the absence of systemic absorption of sertaconazole after the application of a vaginal suppository, side effects are unlikely to occur. However, there may be the rare occasions of allergic reactions and the manifestation of local intolerance such as a feeling of burning sensation or exacerbation of pruritus which generally disappears on discontinuation of treatment.

No embryotoxic or teratogenic effects have been observed in animal studies. No teratogenic and lactation studies have been done in humans.

• Upon confirmation of diagnosis, etiological factors causing the infection should be investigated, and patients should be counseled so as to avoid future recurrence.
• Use soaps which are of neutral or alkaline pH when washing the outer genitals, as lower pH favours candidiasis.
• Practice good personal hygiene; wear preferably cotton underclothes; avoid vaginal douches.
• If mycosis occurs on the vulvar or perianal areas, apply an antifungal cream on these areas.
• Consider the treatment of sexual partner wherever applicable for each specific case.
• Do not interrupt treatment during menstruation.
• Concomitant treatment for any bacterial infection associated with candidiasis is advisable.
• In case of local intolerance or allergic reaction, stop treatment.

Imidazole antifungal agent

Keep this medicine out of the sight and reach of children. Store at temperatures below 30°C. Do not use this medicine after the expiry date, which is written on the packaging after EXP. The expiry date refers to the last day of the respective month.