Metronidazole Tablets, USP Rx Only

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Heritage Pharmaceuticals Inc.

INN (Nome Internazionale):

METRONIDAZOLE

Composizione:

METRONIDAZOLE 250 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Symptomatic Trichomoniasis. Metronidazole tablets 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 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

Dettagli prodotto:

Metronidazole tablets USP, 250 mg are white, round shaped, biconvex, film coated tablets, debossed with “H568” on one side and plain on the other side. They are supplied as follows: NDC Number                Size NDC 23155-568-25       bottle of 50 tablets NDC 23155-568-01       bottle of 100 tablets NDC 23155-568-05       bottle of 500 tablets NDC 23155-568-10       bottle of 1000 tablets Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with “H569” on one side and plain on the other side. They are supplied as follows: NDC Number                Size NDC 23155-569-25       bottle of 50 tablets NDC 23155-569-01       bottle of 100 tablets NDC 23155-569-05       bottle of 500 tablets NDC 23155-569-10       bottle of 1000 tablets Storage and Stability: Store below 77°F (25°C) and protect from light.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METRONIDAZOLE 250 MG- METRONIDAZOLE TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC.
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METRONIDAZOLE TABLETS, USP
RX ONLY
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.
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,
USP. Inactive ingredients
include anhydrous lactose, microcrystalline cellulose, hydroxypropyl
cellulose, sodium starch
glycolate, colloidal silicon dioxide and stearic acid. The film
coating contains hypromelloses,
hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac,
diacetylated monoglycerides and
propylene glycol.
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 metabolite