METRONIDAZOLE tablet, coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Tersedia dari:

Lupin Pharmaceuticals, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Metronidazole tablets USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Metronidazole tablets USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In mak

Ringkasan produk:

Metronidazole Tablets USP, 250 mg are tablets are blue colored, round, film coated tablet, debossed with 'LU' on one side and 'M56' on the other side; supplied as bottles of 50, 100 and 500. Bottles of 50 tablets: NDC 68180-683-08 Bottles of 100 tablets: NDC 68180-683-01 Bottles of 500 tablets: NDC 68180-683-02 Metronidazole Tablets USP, 500 mg are Blue colored, oblong, film coated tablet, debossed with 'LU' on one side and 'M57' on the other side; supplied as bottles of 50, 100 and 500. Bottles of 50 tablets: NDC 68180-684-08 Bottles of 100 tablets: NDC 68180-684-01 Bottles of 500 tablets: NDC 68180-684-02 Store at 25°C (77°F) excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] and protect from light. Dispense in tight, light-resistant, child-resistant containers (USP).

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METRONIDAZOLE - METRONIDAZOLE TABLET, COATED
LUPIN PHARMACEUTICALS, INC.
----------
METRONIDAZOLE TABLETS USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF METRONIDAZOLE AND OTHER ANTIBACTERIAL DRUGS,
METRONIDAZOLE
SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
BOXED WARNING
Metronidazole has been shown to be carcinogenic in mice and rats
_[see_
_Precautions]._ Unnecessary use of the drug should be avoided. Its use
should be
reserved for the conditions described in the INDICATIONS AND USAGE
section
below.
DESCRIPTION
Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of
the synthetic
nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol,
which has the
following structural formula:
Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole.
Inactive
ingredients include colloidal silicon dioxide, croscarmellose sodium,
FD&C blue #2,
hypromellose, low substituted hydroxypropyl cellulose,
microcrystalline cellulose,
polyethylene glycol, stearic acid, titanium dioxide.
CLINICAL PHARMACOLOGY
ABSORPTION
Disposition of metronidazole in the body is similar for both oral and
intravenous dosage
forms. Following oral administration, metronidazole is well absorbed,
with peak plasma
concentrations occurring between one and two hours after
administration.
Plasma concentrations of metronidazole are proportional to the
administered dose. Oral
administration of 250 mg, 500 mg, or 2,000 mg produced peak plasma
concentrations
of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively. Studies reveal no
significant
bioavailability differences between males and females; however,
because of weight
differences, the resulting plasma levels in males are generally lower.
DISTRIBUTION
Metronidazole is the major component appearing in the plasma, with
lesser quantities of
metabolites also being present. Less than 20% of the circulating
metronidazole is bound
to plasma proteins. Metronidazole a