TINIDAZOLE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lupin Pharmaceuticals,Inc.

INN (Internationale Bezeichnung):

TINIDAZOLE

Zusammensetzung:

TINIDAZOLE 250 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Tinidazole Tablets 250 mg tablets are pink, round, scored tablets, debossed with "N" scored "L" on one side and "550" on the other side, supplied in bottles with child-resistant caps as: NDC 43386-550-04    Bottle of 40 Tinidazole Tablets 500 mg tablets are pink, oval, scored tablets, debossed with "N" scored "L" on one side and "551" on the other side, supplied in bottles with child-resistant caps as: NDC 43386-551-06    Bottle of 60 NDC 43386-551-02    Bottle of 20 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.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TINIDAZOLE- TINIDAZOLE TABLET
LUPIN PHARMACEUTICALS,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
Contraindications (4) 12/2021
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 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
tinidazole tablets 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
partner s 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