Inserdin

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

1 vag supp once daily, in the evening, for 7 days. Recurrent or resistant vaginitis 1 supp once daily, in the evening, for 14 days. Patient w/ hepatic encephalopathy Reduce dose to ¹/₃.

Hypersensitivity to metronidazole, miconazole nitrate or other nitroimidazole derivatives. Epilepsy; porphyria; severe liver function impairment. 1st trimester of pregnancy. Lactation. Childn <18 yr.

Patients w/ alteration of hematopoietic function; central & peripheral nervous system disorders; serious renal impairment requiring hemodialysis; serious liver impairment; hepatic encephalopathy. Possible change in the values of transaminases & glycemia. Not to be swallowed or applied by other routes. Avoid sexual contacts during treatment. Simultaneous treatment of sexual partner is recommended as prophylaxis for reinfection; administer systemic medicinal products in the case of trichomonal vaginitis. Do not take alcohol during therapy & for 3 days after end of treatment. May affect ability to drive or operate machinery. 2nd & 3rd trimester of pregnancy.

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

Metronidazole: Disulfiram-like reaction w/ alcohol. Increased risk of cardiotoxicity w/ amiodarone. Increased plasma conc of astemizole & terfenadine. CNS-related effects (eg, psychotic reactions) w/ disulfiram. Increased blood levels of phenytoin; decreased blood levels of metronidazole w/ phenytoin. Decreased blood levels w/ phenobarb. Increased blood levels & toxicity of fluorouracil & lithium. Increased blood conc of carbamazepine. Increased effect of oral anticoagulants. Increased toxicity risk of cyclosporine. 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, dicoumarol, phenindione, phenprocoumon, warfarin. Increased plasma conc of astemizole, cisapride, terfenadine. Increased toxicity risk of phenytoin & fosphenytoin; cyclosporine; trimetrexate. Increased or prolonged effects of opioid (eg, fentanyl). Increased hypoglycemic action of glimepiride. Decreased metabolism of carbamazepine. Increased plasma conc or exposure to oxybutinin. Increased plasma conc & reduced clearance of oxycodone. Increased cardiotoxicity risk w/ pimozide. Increased bioavailability of tolterodine in individuals w/ deficient CYP2D6 activity.

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