METRONIDAZOLE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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). 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. 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 mak

Dettagli prodotto:

Metronidazole Tablets USP, 500 mg are white to off-white, modified oval shape tablets with “I” on one side and “125” on the other side. Bottles of 30 NDC 70934-801-30 Bottles of 21 NDC 70934-801-21 Bottles of 14 NDC 70934-801-14

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METRONIDAZOLE- METRONIDAZOLE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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METRONIDAZOLE TABLETS, USP RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of metronidazole
tablets, USP and other antibacterial drugs, metronidazole tablets, 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 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:
Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole.
Inactive ingredients include
colloidal silicon dioxide, crospovidone, magnesium stearate,
microcrystalline cellulose, and stearic
acid.
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 c