METRONIDAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cadila Healthcare Limited

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 70771-1045-1 in bottles of 100 tablets NDC 70771-1045-8 in bottles of 250 tablets NDC 70771-1045-5 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 70771-1046-7 in bottles of 50 tablets NDC 70771-1046-1 in bottles of 100 tablets NDC 70771-1046-5 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 Rev.: 04/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE TABLET
CADILA HEALTHCARE LIMITED
----------
METRONIDAZOLE TABLETS USP
RX ONLY
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
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
femal