METRONIDAZOLE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Rising Pharmaceuticals, Inc.

INN（国际名称）:

METRONIDAZOLE

组成:

METRONIDAZOLE 250 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Symptomatic Trichomoniasis. METRONIDAZOLE, 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, 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 who has a negat

產品總結:

METRONIDAZOLE Tablets, USP 250 mg are white to off-white, round shaped tablets debossed with “MCR 104” on one side and plain on other side and supplied as bottles of 100's, 250's, 500's counts. METRONIDAZOLE Tablets, USP 500 mg are white to off-white, oval shaped tablets debossed with “MCR 105” on one side and plain on other side and supplied as bottles of 50's, 100's, 500's counts. Storage and Stability: Store below 77°F (25°C) and protect from light.

授权状态:

Abbreviated New Drug Application

产品特点

METRONIDAZOLE- METRONIDAZOLE TABLET
RISING PHARMACEUTICALS, INC.
----------
METRONIDAZOLE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
METRONIDAZOLE, USP and other antibacterial drugs, METRONIDAZOLE, 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, USP 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,
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 similar to those
found in plasma. Bactericidal co