Composition
Each one gram of the cream contains: miconazole nitrate 20 mg.
Each vaginal ovule contains: miconazole nitrate 200 mg or 400 mg.
Indications
Gyno-Mikozal is indicated for the local treatment of vulvovaginal candidiasis caused by Candida albicans and other species of Candida in pregnant (second and third trimesters only) and nonpregnant women. It may also be used for the treatment of mycotic balanitis.
Since miconazole nitrate is effective against certain strains of Gram-positive bacteria, it may be used in cases of mycoses secondarily infected with such bacteria.
Contraindications
Hypersensitivity to miconazole or any other ingredient.
Precautions
If a reaction suggesting sensitivity or irritation should occur, treatment should be discontinued. General hygienic measures should be observed to control sources of infection or reinfection. Appropriate therapy is indicated if the sexual partner is also infected.
Pregnancy and Lactation
Pregnancy: No adverse effects have been reported. However, it should only be used in the first trimester of pregnancy when it is considered essential to the welfare of the patient.
Lactation: Problems in humans have not been documented.
Dosage and Administration
Cream: The content of one applicator (5 g) of cream should be emptied deeply into the vagina once daily at bedtime for 10-14 days or twice daily for 7 days.
Ovule: A single daily dose of 200 mg vaginal ovule for one week or 400 mg vaginal ovule for 3 days to be inserted deeply into the vagina at bed time.
The entire course of treatment should be completed even when symptoms disappear rapidly. It should be continued during menstruation. If needed, a further course of treatment can be given.
For treatment of vulvitis and other superficial sites of infection that are almost invariably associated with vaginal candidiasis, vaginal application of Gyno-Mikozal can be supplemented with topical application
of the cream to anogenital area twice daily.
Packaging
cr: 78 g
ov: 200 mg x 7
400 mg x 3.