METRONIDAZOLE500 MG 500 MG- metronidazole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cambridge Therapeutics Technologies, LLC

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with “H569” on one side and plain on the other side. They are supplied as follows: NDC 70882-131-14, Unit of Use Bottles of 14 Tablets Storage and Stability: Store below 77°F (25°C) and protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE500 MG 500 MG- METRONIDAZOLE TABLET, FILM COATED
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, 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 anhydrous lactose, microcrystalline cellulose, hydroxypropyl
cellulose, sodium starch
glycolate, colloidal silicon dioxide and stearic acid. The film
coating contains hypromelloses,
hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac,
diacetylated monoglycerides and
propylene glycol.
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 quantit