METRONIDAZOLE- metronidazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nivagen Pharmaceuticals, Inc

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Symptomatic Trichomoniasis. Metronidazole tablet, USP is 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). Asymptomatic Trichomoniasis. Metronidazole tablet, USP is 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. Treatment of Asymptomatic Sexual Partners. 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

Product summary:

Metronidazole tablets, USP 250-mg are round, yellow, film coated tablets, with "FL12" debossed on one side and plain on the other side; supplied as bottles of 100, 250 and 500. Metronidazole tablets, USP 500-mg are oval, yellow, film coated tablets with, "FL11" debossed on one side and plain on the other side; supplied as bottles of 50, 100 and 500.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE TABLET
NIVAGEN PHARMACEUTICALS, INC
----------
METRONIDAZOLE TABLETS USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of metronidazole
tablets, USP and other antibacterial drugs, metronidazole tablets, USP
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 anhydrous silica, crospovidone, hydroxypropyl cellulose,
hypromellose, iron oxide yellow,
microcrystalline cellulose, polyethylene glycol, stearic acid and
titanium dioxide.
CLINICAL PHARMACOLOGY
ABS ORPTION
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.
DIS TRIBUTION
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 appears