Metindaz

Metronidazole 500 mg, miconazole nitrate 100 mg

Candidal vulvovaginitis due to Candida albicans, bacterial vaginosis due to anaerobic bacteria & Gardnerella vaginalis, trichomonal vaginitis due to Trichomonas vaginalis & mixed vag infections.

1 supp administered in a supine position at night & in the morning for 7 days. Recurrent vaginitis or vaginitis resistant to treatment 1 supp once daily in the evening for 14 days.

Hypersensitivity to other nitroimidazole derivatives. Epilepsy. Porphyria. Severe liver function impairment. Pregnancy (1st trimester) & lactation. Childn <18 yr (virgins).

Do not swallow or apply by other routes. Hepatic encephalopathy patients. Patients w/ alteration of hematopoietic function, central & peripheral nervous system disorders. Avoid sexual contacts during treatment. Reduced efficacy of local contraception (preservatives, vag diaphragms). Simultaneous treatment of sexual partner in case of trichomonadal vaginitis. Do not take alcohol during therapy & for 3 days after the end of treatment. Disulfiram-like reaction. Change in values of transaminases & glycemia during treatment. May affect ability to drive & use machines. Serious impaired renal function in which hemodialysis is required. Proper birth control method in women of childbearing potential. Pregnancy (2nd & 3rd trimester).

Pain or abdominal spasms, metallic taste, xerostomia, constipation, diarrhea, loss of appetite, nausea, vomiting; headache, motor abnormalities (ataxia), vertigo, psycho-emotional disorders, peripheral neuropathy (long-term use), cramps; leucopenia; dark-brown coloration of urine; urticaria, prurigo of teguments, eruption; itching, burning, pain & irritation of vag mucosa.

Inhibited metabolism & increased plasma conc of astemizole & terfenadine. Increased cyclosporine toxicity risk. Metronidazole: Alcohol intolerance (disulfiram-like reaction) w/ alcohol. Increased risk of cardiotoxicity w/ amiodarone. CNS-related effects (eg, psychotic reactions) w/ disulfiram. Increased blood levels of phenytoin. Decreased blood levels of metronidazole w/ phenytoin; phenobarb. Increased blood levels & toxicity of fluorouracil; lithium. Increased blood conc of carbamazepine. Increased anticoagulant effect of oral anticoagulants. Increased blood levels & risk of neurologic side effects w/ cimetidine. Interference w/ blood levels of liver enzymes, glucose (hexokinase method), theophylline & procainamide. Miconazole nitrate: Increased bleeding risk w/ acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon, warfarin. Inhibited metabolism & increased plasma conc of cisapride. Increased phenytoin toxicity risk w/ phenytoin & fosphenytoin. Increased or prolonged opioid effects of fentanyl. Increased hypoglycemic action of glimepiride. Decreased carbamazepine metabolism. Increased plasma conc or exposure to oxybutynin. Increased oxycodone plasma conc & reduction in clearance. Increased cardiotoxicity risk w/ pimozide. Increased tolterodine bioavailability in individuals w/ deficient cytochrome P450 2D6 activity. Increased trimetrexate toxicity.

Preparations for Vaginal Conditions

G01AF20 - combinations of imidazole derivatives ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.

Rx