METRONIDAZOLE tablet film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

REMEDYREPACK INC.

INN (mednarodno ime):

METRONIDAZOLE

Sestava:

METRONIDAZOLE 250 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METRONIDAZOLE- METRONIDAZOLE TABLET, FILM COATED
REMEDYREPACK INC.
----------
METRONIDAZOLE TABLETS USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of metronidazole
tablets and other antibacterial drugs, metronidazole tablets 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, 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
powdered cellulose, hydroxypropyl cellulose, low substituted
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 mil