METRONIDAZOLE- metronidazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Symptomatic Trichomoniasis 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). Asymptomatic Trichomoniasis 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. 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 wh

Product summary:

Metronidazole tablets, USP, 500 mg are available as white, oblong tablets, debossed with "3970 " on one side and "WPI " on the other side and are packaged in bottles of 14, 21, 28, 30 and 42. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). Bottles of 14 NDC 68788-6843-01 Bottles of 21 NDC 68788-6843-02 Bottles of 28 NDC 68788-6843-04 Bottles of 30 NDC 68788-6843-03 Bottles of 42 NDC 68788-6843-07 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
METRONIDAZOLE TABLETS, USP
250 MG AND 500 MG
REVISED: SEPTEMBER 2015
RX ONLY
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.
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 250 mg and 500 mg tablets, USP, for oral administration,
contain the inactive ingredients:
colloidal silicon dioxide, hydroxypropyl cellulose, lactose
(anhydrous), microcrystalline cellulose,
sodium starch glycolate, and stearic acid.
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.
Metronid