METRONIDAZOLE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

RedPharm Drug, Inc.

DCI (Denominação Comum Internacional):

METRONIDAZOLE

Composição:

METRONIDAZOLE 500 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 m

Resumo do produto:

Metronidazole Tablets USP, 250 mg are white to off-white, round shaped uncoated tablets, debossed with ‘K’ on one side and ‘10’ on other side. Bottles of 50 NDC 65862-694-50 Bottles of 100 NDC 65862-694-01 Bottles of 250 NDC 65862-694-25 Bottles of 500 NDC 65862-694-05 Bottles of 1,000 NDC 65862-694-99 Metronidazole Tablets USP, 500 mg are white to off-white, oblong shaped uncoated tablets, debossed with ‘K’ on one side and ‘11’ on other side. Bottles of 50 NDC 65862-695-50 Bottles of 100 NDC 65862-695-01 Bottles of 500 NDC 65862-695-05 Bottles of 1,000 NDC 65862-695-99 Storage and Stability Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Status de autorização:

Abbreviated New Drug Application

Características técnicas

METRONIDAZOLE- METRONIDAZOLE TABLET
REDPHARM DRUG, INC.
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BOXED WARNING
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.
SPL UNCLASSIFIED SECTION
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.
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:
[Chemical Structure]
Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole
USP. Inactive
ingredients include colloidal silicon dioxide, hydroxypropyl
cellulose, microcrystalline
cellulose, pregelatinized starch (maize), sodium starch glycolate, and
stearic acid.
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