tindazole tinidazole tablet film coated tindazole tinidazole tablet film coated
1 INDICATIONS AND USAGE Tinidazole Tablets is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in non-pregnant, adult women ( 1.4, 8.1 ) 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection [see Clinical Studies ( 14.1 )]. 1.2 Giardiasis Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia ) in both adults and pediatric patients older than three years of age [see Clinical Studies ( 14.2 )]. 1.3 Amebiasis Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage [see Clinical Studies ( 14.3, 14.4 )]. 1.4 Bacterial Vaginosis Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women [see Use in Specific Populations ( 8.1 ) and Clinical Studies ( 14.5 )]. Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
pack pharmaceuticals, llc
ROUND PINK TP 250
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tindazole tinidazole tablet film coated tindazole tinidazole tablet film coated
pack pharmaceuticals, llc
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16 HOW SUPPLIED/STORAGE AND HANDLING Tinidazole Tablets 250 mg are pink, circular, film-coated scored tablets, with T│P debossed on one side and 250 on the other, supplied in bottles with child-resistant caps as: NDC 16571-214-04 Bottle of 40 Tinidazole Tablets 500 mg are pink, capsule shaped, film-coated scored tablets, with T│P debossed on one side and 500 on the other, supplied in bottles with child-resistant caps as: NDC 16571-215-22 Bottle of 20 NDC 16571-215-06 Bottle of 60 Storage: Store at controlled room temperature 20-25° C (68-77° F); excursions permitted to 15-30° C (59-86° F) [see USP]. Protect contents from light.
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