Properties
What is it?
International Nonproprietary Name - metronidazole, miconazole Clinical-pharmacological group: Antiprotozoal agents → Nitroimidazole derivatives → For local use Dosage form: Vaginal tablets Composition Each vaginal tablet contains: Active ingredients: Metronidazole – 100 mg, Miconazole nitrate – 100 mg. Excipients: Sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, povidone, sodium bicarbonate, tartaric acid, sodium carboxymethyl starch (Type A), crospovidone, hypromellose, lactose monohydrate. Description Biconvex, oval vaginal tablets with a pointed end, almost white in color, approximately 24mmX14mm in size, with the engraving "100" on one side. Pharmacotherapeutic group Antimicrobial and antiseptic agents, excluding combinations with corticosteroids. Imidazole derivatives. Indications for use Local treatment of trichomoniasis and/or fungal infections of the genitourinary tract in women. Method of administration and dosage For trichomoniasis: Simultaneously with oral administration of metronidazole, insert 1 Klon-D-100 vaginal tablet, pre-moistened, deep into the vagina once a day (in the evening before bedtime) for 10 days. During these 10 days, it is necessary to take 2 metronidazole tablets (250 mgX2) orally daily (one tablet in the morning and one tablet in the evening) during or after meals, without chewing. Full recovery can only be achieved if the sexual partner simultaneously undergoes a course of metronidazole treatment (oral tablets). In case of treatment inefficiency: The 10-day treatment course can be repeated. For candidiasis: Insert 1 Klon-D-100 vaginal tablet, pre-moistened, deep into the vagina once a day (in the evening before bedtime) for 10 days. Contraindications Hypersensitivity to the active substances or any of the excipients of the preparation. First trimester of pregnancy. Use during pregnancy and lactation Pregnancy The preparation is contraindicated in the first trimester of pregnancy. Metronidazole, when taken orally, crosses the placental barrier and quickly enters the fetal blood. In reproductive toxicity studies in rats, doses up to 5 times higher than those intended for humans were used. No signs of fertility disorders or fetal damage were detected in these studies under the influence of metronidazole. When administered intraperitoneally to mice at a dose approximately equal to the human dose, metronidazole had a fetotoxic effect. However, no fetotoxic effect was observed when metronidazole was administered orally to pregnant mice. Nevertheless, there are currently no adequate and controlled studies in pregnant women.