Generic: Metronidazole Miconazole Nitrate  |  Dosage Form: Vaginal Tablet  |  Manufacturer: Ambee Pharmaceuticals Ltd.

Indications

Vaginal treatment of female urogenital trichomonas infection, prevention & local therapy of candidiasis.

Dosage & Administration

In trichomoniasis, concurrently with oral metronidazole treatment and 1 vaginal tablet should be inserted high up into the vagina once a day (preferably before going to bed at night) for 10 days. Long-term recovery may be expected only is response to the simultaneous oral treatment of both partners.

In candidiasis or other fungal infections, 1 vaginal tablet has to be inserted high up into the vagina for 10 days. The vaginal tablet should be slightly moistened before application.

Interaction

Metronidazole: Disulfiram-like reaction with alcohol. Increased oral anticoagulant effect, blood levels of phenytoin, lithium toxicity, plasma cone of astemizole & terfenadine; blood cone of carbamazepine. Decreased blood levels with phenobarb. Risk of CNS-related effects (eg psychotic reactions) with disulfiram. Increased blood levels & neurologic effects with cimetidine. May increase blood levels & toxicity of fluorouracil; toxicity of cyclosporine. Increased cardiotoxicity with amiodarone. Interference with blood levels of liver enzymes, glucose (hexokinase method), theophylline & procainamide. Decreased levels with phenytoin.

Miconazole: Increased risk of bleeding with acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon, warfarin; plasma cone & exposure to oxybutinin.

May increase risk of phenytoin, phosphenytoin, cyclosporine, trimetrexate toxicity & cardiotoxicity with pimozide. May inhibit metabolism of astemizole, cisapride & terfenadine. Reduced carbamazepine metabolism. Increased or prolonged effects of opioid (fentanyl). May cause hypoglycemia with glimepiride. Reduced clearance & increased plasma cone of oxycodone. May increase bioavailability of tolterodine (in patients with deficient CYP2D6 activity).

Contraindications

Hypersensitivity; hepatic impairment (oral gel). Porphyria.

Side Effects

Nausea, vomiting, febrile reactions, rash, drowsiness, diarrhoea, anorexia and flushing, hepatitis. Local irritation and sensitisation, contact dermatitis.

Precautions & Warnings

For external use only; discontinue if sensitization or irritation occurs. Pregnancy and lactation

Therapeutic Class

Drugs used in Vaginal and Vulval condition