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.   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 simul

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 72578-007-01 in bottles of 100 tablets NDC 72578-007-21 in bottles of 250 tablets NDC 72578-007-05 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 72578-008-18 in bottles of 50 tablets NDC 72578-008-01 in bottles of 100 tablets NDC 72578-008-05 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). Manufactured   by: Cadila Healthcare Ltd. India Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 Rev.: 01/19

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METRONIDAZOLE- METRONIDAZOLE TABLET
REDPHARM DRUG, INC.
----------
METRONIDAZOLE 500MG TABLETS
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 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 between males and females; however,