Gyno Daktarin 7

/ Janssen

Once daily before bedtime, administer the contents of 1 applicator (about 5 g of cream) deeply into the vagina. Repeat this procedure for 7 days, even if symptoms (e.g. pruritus and leukorrhea) have disappeared or menstruation begins. Treatment of concurrent symptoms of mycotic balanitis of the male partner: apply the cream twice daily on the glans penis. The treatment duration is the same as for the female partner.
For full details see prescribing information.

Vulvovaginal candida and superinfection due to gram +tve bacteria.

Hypersensitivity, use of a vaginal applicator.

Should local sensitization or an allergic reaction occur, the treatment should be discontinued. Appropriate therapy is indicated when the sexual partner is also infected. These products do not stain skin or clothes. The concurrent use of latex condoms or diaphragms with vaginal antiinfective preparations may decrease the effectiveness of latex contraceptive agents. Therefore products should not be used concurrently with a latex condom or latex diaphragm.

The safety of this product was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. For full details see prescribing information.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and the anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and CYP3A4 (e.g., HMGCoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised. Contact should be avoided between latex products such as contraceptive diaphragms or condoms and this product since the constituents of this product may damage the latex.

Use during pregnancy: Although intravaginal absorption is limited, this product should be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.
Use during lactation: It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using this Cream, during lactation.

These products are intended for local application and not for oral use. In the event of accidental ingestion of large quantities of product, an appropriate method of gastric emptying may be used, if considered necessary.