TINIDAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals NJ, LLC

INN (International Name):

TINIDAZOLE

Composition:

TINIDAZOLE 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TINIDAZOLE- TINIDAZOLE TABLET
INGENUS PHARMACEUTICALS NJ, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TINIDAZOLE TABLETS FOR ORAL USE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TINIDAZOLE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TINIDAZOLE TABLETS.
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. 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
WARNINGS AND PRECAUTIONS
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)
INDICATIONS AND USAGE
Tinidazole is a nitroimidazole antimicrobial indicated for:
Trichomoniasis (1.1)
Giardiasis: in patients age 3 and older
Amebiasis: in patients age 3 and older (1.3)
Bacterial Vaginosis: in non-pregnant, adult women (1.48.1)
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 to 5 days with
food. Pediatric patients older than three years of age: 50 mg/kg