Description : Each vaginal suppository contains metronidazole 750 mg and miconazole nitrate 200 mg.
Indications / Uses : Treatment of vaginal candidiasis caused by Candida albicans, bacterial vaginitis caused by anaerobic bacteria and Gardnerella vaginalis, trichomonal vaginitis caused by Trichomonas vaginalis and mixed vaginal infections.
Administration : The ovule/supp should be applied in lying position and inserted high into the vagina. If possible do not stand up for half an hour after placing the suppository.
Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte-L should not be used without consulting a physician.
Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte-L is not to be swallowed or administered by other routes.
Contraindications : Known hypersensitivity to any active ingredients or derivatives of Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte-L. Patients with severe liver function disorders (including porphyria), nervous system disoders (eg, epilepsy) and hematopoiesis.
Use in pregnancy: Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte-L is contraindicated for use during the 1st trimester of pregnancy in women.
Special Precautions : Patients should be warned not to take alcohol during the therapy and for at least 2 days after the end of a course of treatment because of the possibility of disulfiram-like reactions.
High doses and long-term systemic use may cause peripheral neuropathy and convulsion.
The base contained in the vaginal suppository formulation may interact with certain rubber or latex products eg, those used in vaginal contraceptive diaphragms or condoms, therefore concurrent use is not recommended.
Sexual partners of patients with Trichomonas vaginalis should be treated at the same time.
Metronidazole dose must be reduced in renal failure.
In serious liver function failures, metronidazole clearance may be impaired. Metronidazole may increase encephalopathy symptoms due to increased plasma levels and therefore should be used carefully in hepatic encephalopathy patients. The daily dose of metronidazole must be reduced to1/2 in patients with hepatic encephalopathy. The t? of lidocaine may be prolonged less than 2-folds in patients with impaired liver function. Impaired renal function does not affect the pharmacokinetics of lidocaine but may increase accumulation of metabolites.
Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte L is not recommended for use in virgins.
Use in pregnancy & lactation: Pregnancy Category B for metronidazole and lidocaine and pregnancy category C for miconazole. After the 1st trimester of pregnancy, Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte-L may be used in cases considered essential by a physician, but should be used under control.
Breastfeeding should be discontinued since metronidazole appears in the milk. It can be started again 24-48 hrs after the end of treatment. It is not known whether lidocaine is excreted in human milk; therefore, caution should be observed when Neo-Penotran Forte L is administered to a nursing woman.
Use in children: Neo-Penotran/Neo-Penotran Forte/Neo-Penotran Forte-L is not recommended for children.