METRONIDAZOLE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

RedPharm Drug, Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Symptomatic Trichomoniasis. Metronidazole tablets, USP are indicated for the treatment of T. vaginalisinfection 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 male partner who

Каталог на резюме:

Metronidazole Tablets USP, 250 mg are white to off-white, round, biconvex, film coated tablets debossed with '850' on one side and plain on other side and are supplied as follows: NDC 68382-850-01 in bottles of 100 tablets NDC 68382-850-21 in bottles of 250 tablets NDC 68382-850-05 in bottles of 500 tablets Metronidazole Tablets USP, 500 mg are white to off-white, oval shaped, biconvex, film coated tablets debossed with '851' on one side and plain on other side and are supplied as follows: NDC 68382-851-18 in bottles of 50 tablets NDC 68382-851-01 in bottles of 100 tablets NDC 68382-851-05 in bottles of 500 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (USP). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Cadila Healthcare Ltd. Baddi, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Rev.: 04/18

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METRONIDAZOLE- METRONIDAZOLE TABLET
REDPHARM DRUG, INC.
----------
METRO 500
BOXED WARNING
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.
SPL UNCLASSIFIED SECTION
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.
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:
[figure]
Metronidazole USP is a white to pale yellow, crystalline powder. It is
sparingly soluble in water and
alcohol; slightly soluble in ether and chloroform; soluble in dilute
hydrochloric acid.
Each metronidazole tablet, USP intended for oral administration
contains 250 mg or 500 mg of
metronidazole. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, hypromellose, low-substituted hydroxypropyl cellulose,
microcrystalline cellulose and stearic
acid. Additionally each tablet contains opadry II white 02F580003
which contains hypromellose,
polyethylene glycol, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
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 betwee