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:

Rising Pharma Holdings, Inc.

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 vagin

Product summary:

Tinidazole Tablets USP 250 mg are pink color, circular shaped film coated scored tablets  with "250" debossed on one side and " T│P" on the other side, supplied in bottles with child-resistant caps as: NDC 64980-426-02           Bottle of 20 Tinidazole Tablets USP 500 mg are pink color, capsule shaped film coated scored tablets  with "500" debossed on one side and " T│P" on the other side, supplied in bottles with child-resistant caps as: NDC  64980-427-12           Bottle of 12 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
RISING PHARMA HOLDINGS, INC.
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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
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.
LIMIT USE OF TINIDAZOLE TABLETS TO APPROVED INDICATIONS ONLY (1.1,
1.2, 1.3). AVOID
CHRONIC USE (5.1).
INDICATIONS AND USAGE
Tinidazole Tablet 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 adult women (1.4,8.1)
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 (1.5).
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. Pediatric patients older than three
years of age: 50 mg/kg/day (up to 2 g
per day) for 3-5 days with food (2.5)
Bacterial vaginosis: Adult women: 2 g once da