METRONIDAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metronidazole tablets 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 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

Product summary:

Metronidazole Tablets, USP are available as follows: 500 mg - White, oblong, convex tablets debossed “ PLIVA 334 ” on one side and unscored on the other side. Available in bottles of 4 ( NDC 43063-021-04) ). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE TABLET
PD-RX 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.
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, 1 _H_-Imidazole-1-ethanol,
2-methyl-5-nitro, which has the
following structural formula:
C
H
N
O
M.W. 171.15
Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole,
USP. Inactive
ingredients include silicified microcrystalline cellulose,
crospovidone, colloidal silicon
dioxide and hydrogenated vegetable oil.
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 appears in cerebrospinal fluid,
saliva, and breast milk
in concentrations simi