Gyno-Daktarin_™ - Product Information

Miconazole nitrate 100 mg vaginal cream.

Presentation

Gyno-Daktarin Cream contains the synthetic bactericidal and fungicidal broad-spectrum antifungal agent miconazole nitrate.

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Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.

Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.

In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.

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.

Indications

Local treatment of vulvovaginal candidiasis and superinfections due to gram-positive bacteria.

Gyno-Daktarin Cream may also be used for the treatment of mycotic balanitis.

Dosage and Administration

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.

Contraindications

Gyno-Daktarin Cream is contraindicated in individuals with a known hypersensitivity to miconazole or any other components of these medicines.

Warnings and Precautions

Should 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.

Pregnancy and Lactation

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.

It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Daktarin Cream during lactation.

Adverse Effects

Gyno-Daktarin 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.

Interactions

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

Overdosage

In the event of accidental ingestion of large quantities of either of these medicines, an appropriate method of gastric emptying may be used if considered appropriate.