FLAGYL- metronidazole capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Symptomatic Trichomoniasis . FLAGYL 375 capsules 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 . FLAGYL 375 capsules 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 who has

Product summary:

FLAGYL 375 capsules have an iron gray opaque body imprinted with 375 mg and a light green opaque cap imprinted with FLAGYL, supplied as: NDC Number Size 0025-1942-50     Bottle of 50 0025-1942-34     Carton of 100 unit dose Store at controlled room temperature 15–25°C (59–77°F). Dispense in a well-closed container with a child-resistant closure.

Authorization status:

New Drug Application

Summary of Product characteristics

FLAGYL- METRONIDAZOLE CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
----------
FLAGYL
(METRONIDAZOLE) CAPSULES
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) capsules, 375 mg is an oral formulation of the
synthetic
nitroimidazole antimicrobial agent,
2-methyl-5-nitro-1_H_-imidazole-1-ethanol, which has
the following structural formula:
FLAGYL (metronidazole) capsules, 375 mg, (indicated below as FLAGYL
375 capsules)
contain 375 mg of metronidazole USP. Inactive ingredients include corn
starch,
magnesium stearate, gelatin, black iron oxide, titanium dioxide, FD&C
Green No. 3, and
D&C Yellow No. 10.
CLINICAL PHARMACOLOGY
ABSORPTION
Disposition of metronidazole in the body is similar for both oral and
intravenous dosage
forms.
FLAGYL 375 capsules have been shown to have a rate and extent of
absorption similar
to metronidazole tablets (FLAGYL) and were bioequivalent at an equal
single dose of 750
mg. In a study conducted with 23 adult, healthy, female volunteers,
oral administration
of two 375 mg FLAGYL capsules under fasted conditions produced a mean
(±1 SD)
peak plasma concentration (C
) of 21.4 (±2.8) mcg/mL with a mean T
of 1.6 (±
®
®
®
max
max
0.7) hours and a mean area under the plasma concentration-time curve
(AUC) of 223
(±44) mcg∙hr/mL. In the same study, three 250 mg FLAGYL tablets
produced a mean
C
of 20.4 (± 3.8) mcg/mL with a mean T
of 1.4 (± 0.4) hours and a mean AUC of
218 (± 50) mcg∙hr/mL.
Administration of FLAGYL 375 capsules with food does not affect the
extent of
absorption of metronidazole; however, the presence of food r