Indications: vaginal and vulvar candidiasis. Local treatment of vulvovaginal candidiasis and superinfections due to gram-positive bacteria. The Cream may also be used for the treatment of mycotic balanitis.

Cautions: if local sensitisation or an allergic reaction occur, the treatment should be discontinued. General hygienic measures should be observed to control sources of infection and reinfection.

Appropriate therapy is indicated when the sexual partner is also infected. cautions should be exercised when using the Cream during breast-feeding.

Contra-indications: in individuals with a known hypersensitivity to miconazole or any other components of these medicines.

Side Effects: Cream is usually well tolerated, and adverse reactions are rare and mild in most cases.

A few cases of local irritation, pruritus and burning sensation have been observed, especially at the start of treatment. Complaints of pelvic cramping, hives, skin rash have also been reported.

Drug Interactions: Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and the cream since the rubber may be damaged. Unintended pregnancy or transmission of infectious disease may result.

Pharmacokinetics: Systemic absorption after intravaginal administration is limited. Eight hours after application 90% of miconazole nitrate is still present in the vagina. Unchanged miconazole could not be traced in blood plasma or urine.

Dose: Once daily (before bedtime), the contents of one applicator (approximately 5g of cream) should be squeezed deeply into the vagina, for seven days, even after pruritis and leukorrhoea has disappeared and regardless of intervening mensturation. Insert 1 pessary daily for 14 days or 1 pessary twice daily for 7 days.

Pregnancy: Although intravaginal absorption is limited, Gyno-daktarin should only be used in the first trimester of pregnancy if, in the judgement of the physician, the potential benefits outweigh the possible risks.

Breast Feeding It is not known whether miconazole nitrate is excreted in human milk.