TINDAZOLE- tinidazole tablet, film coated TINDAZOLE- tinidazole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TINIDAZOLE (UNII: 033KF7V46H) (TINIDAZOLE - UNII:033KF7V46H)

Available from:

Pack Pharmaceuticals, LLC

INN (International Name):

TINIDAZOLE

Composition:

TINIDAZOLE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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)]. 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)]. Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TINDAZOLE- TINIDAZOLE TABLET, FILM COATED
PACK PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TINIDAZOLE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TINIDAZOLE TABLETS
TINIDAZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
TINIDAZOLE TABLETS FOR ORAL USE. INITIAL U.S. APPROVAL: 2004 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 BACTERIA.
WARNING: POTENTIAL RISK FOR CARCINOGENICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CARCINOGENICITY HAS BEEN SEEN IN MICE AND RATS TREATED CHRONICALLY
WITH METRONIDAZOLE, ANOTHER
NITROIMIDAZOLE AGENT (13.1). ALTHOUGH SUCH DATA HAVE NOT BEEN REPORTED
FOR TINIDAZOLE, THE TWO DRUGS ARE
STRUCTURALLY RELATED AND HAVE SIMILAR BIOLOGIC EFFECTS. USE SHOULD BE
LIMITED TO APPROVED INDICATIONS ONLY.
RECENT MAJOR CHANGES
Indications and Usage, Bacterial Vaginosis (1.4) 5/2007
Dosage and Administration, Bacterial Vaginosis (2.6) 5/2007
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)
DOSAGE AND ADMINISTRATION
Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual
partners with the same dose and at the same time
(2.3)
Giardiasis: Adults: a single 2 g dose taken with food. Pediatric
patients older than three years of age: a single dose of 50
mg/kg (up to 2 g) with food (2.4)
Amebiasis, _Intestinal:_ Adults: 2 g per day for 3 days with food.
Pediatric patients older than three years of age: 50
mg/kg/day (up to 2 g per day) for 3 days with food (2.5). _Amebic
liver abscess:_ Adults: 2 g per day for 3-5 days with food.
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