FLAGYL- metronidazole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FLAGYL 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). FLAGYL 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. 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 making this d

Product summary:

FLAGYL 250-mg tablets are round, blue, film coated, with SEARLE and 1831 debossed on one side and FLAGYL and 250 on the other side; supplied as bottles of 50 and 100. FLAGYL 500-mg tablets are oblong, blue, film coated, with FLAGYL debossed on one side and 500 on the other side; bottles of 50 and 100. Store below 25°C (77°F) and protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

FLAGYL- METRONIDAZOLE TABLET, FILM COATED
REDPHARM DRUG
----------
FLAGYL 500MG
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of FLAGYL
and
other antibacterial drugs, FLAGYL
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
FLAGYL (metronidazole) tablets, 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:
FLAGYL (metronidazole) tablets contain 250 mg or 500 mg of
metronidazole. Inactive ingredients
include cellulose, FD&C Blue No. 2 Lake, hydroxypropyl cellulose,
hypromellose, 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 in cerebrospinal fluid, saliva, and breast milk
in concentrations similar to those
®
®
found in plasma. Bacteric