METRONIDAZOLE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Direct_Rx

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 a n

Ringkasan produk:

Metronidazole Tablets USP, 250 mg White colored, round shaped, film coated, biconvex tablets with 'U' debossed on one side and '226' debossed on other side. Bottles of 50: Bottles of 100: Bottles of 250: Bottles of 500: Bottles of 1,000: Metronidazole Tablets USP, 500 mg White colored, capsule shaped, film coated biconvex tablets with 'U' debossed on one side and '227' debossed on other side. Bottles of 50: Bottles of 100: Bottles of 500: Bottles of 1,000: Storage and Stability: Store at 200C to 250C (680 to 770 F) [see USP Controlled Room Temperature]. Protect from light. Please address medical inquiries to Unichem's toll free # 1-866-562-4616.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

METRONIDAZOLE- METRONIDAZOLE TABLET, FILM COATED
DIRECT_RX
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METRONIDAZOLE
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.
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.
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:
[Molecular Structure]
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.
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 breast milk
in concentrations similar to