METRONIDAZOLE - metronidazole tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

LUCID PHARMA LLC

INN (Nama Internasional):

METRONIDAZOLE

Komposisi:

METRONIDAZOLE 250 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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 100                                 NDC 52343-095-01             Bottles of 250                                 NDC 52343-095-25             Bottles of 500                                 NDC 52343-095-05              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 100                                 NDC 52343-096-01             Bottles of 500                                 NDC 52343-096-05              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 otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METRONIDAZOLE - METRONIDAZOLE TABLET
LUCID PHARMA LLC
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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 colloidal silicon dioxide, hydroxypropyl cellulose,
microcrystalline cellulose, pregelatinized
starch (maize), sodium starch glycolate, 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 concentrati