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:

Hikma Pharmaceuticals USA 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 250 mg tablet is supplied as an off-white to pale yellow, round, biconvex, film-coated tablet debossed with product identification “54” over “524” on one side and scored on the other side. NDC 0054-0347-16: Bottle of 40 Tablets 500 mg tablet is supplied as an off-white to pale yellow, modified oval, film-coated tablet debossed with product identification “54 455” on one side and scored on the other side. NDC 0054-0348-07: Bottle of 20 Tablets NDC 0054-0348-21: Bottle of 60 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TINIDAZOLE- TINIDAZOLE TABLET, FILM COATED
HIKMA PHARMACEUTICALS USA INC.
----------
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)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Tinidazole is a nitroimidazole antimicrobial indicated for:
•
•
•
•
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of tinidazole and
other antibacterial drugs, tinidazole 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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg and 500 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
Contraindications (4) 12/2021
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)
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 d