METRONIDAZOLE- metronidazole tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (Διεθνής Όνομα):

METRONIDAZOLE

Σύνθεση:

METRONIDAZOLE 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Symptomatic Trichomoniasis: Metronidazole is indicated for the treatment of symptomatic trichomoniasis 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 is indicated in the treatment of asymptomatic 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 Consorts: 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 negative culture or one for whom no culture ha

Περίληψη προϊόντος:

Metronidazole Tablets, USP: 250 mg - White, round, convex, unscored tablets in bottles of 100, 250, 500 and 1000.                  Debossed: PLIVA 333 500 mg - White, oblong, convex, unscored tablets in bottles of 100, 500 and 1000.                 Debossed: PLIVA 334 Dispense in a well-closed, light-resistant container as defined in the USP. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from light.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

METRONIDAZOLE- METRONIDAZOLE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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METRONIDAZOLE TABLETS, USP
WARNING: Metronidazole has been shown to be carcinogenic in mice
and rats. (See PRECAUTIONS.) Unnecessary use of this drug should
be avoided. Its use should be reserved for the conditions described in
the INDICATIONS AND USAGE section below.
DESCRIPTION:
Metronidazole is an oral synthetic antiprotozoal and antibacterial
agent, 1 (β-hydroxyethyl)-2-methyl-5-
nitroimidazole, which has the following structural formula:
C H N O M.W. 171.16
Each tablet for oral administration contains 250 mg or 500 mg
metronidazole. Inactive ingredients
include microcrystalline cellulose, crospovidone, colloidal silicon
dioxide and hydrogenated
vegetable oil.
CLINICAL PHARMACOLOGY:
Disposition of metronidazole in the body is similar for both oral and
intravenous dosage forms, with an
average elimination half-life in healthy humans of eight hours.
The major route of elimination of metronidazole and its metabolites is
via the urine (60-80% of the
dose), with fecal excretion accounting for 6-15% of the dose. The
metabolites that appear in the urine
result primarily from side-chain oxidation
[1-(β-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and
2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide
conjugation, with unchanged metronidazole
accounting for approximately 20% of the total. Renal clearance of
metronidazole is approximately 10
mL/min/1.73m .
Metronidazole is the major component appearing in the plasma, with
lesser quantities of the 2-
hydroxymethyl metabolite also being present. Less than 20% of the
circulating metronidazole is bound
to plasma proteins. Both the parent compound and the metabolite
possess _in vitro_ bactericidal activity
against most strains of anaerobic bacteria and _in vitro
_trichomonacidal activity.
Metronidazole appears in cerebrospinal fluid, saliva, and human milk
in concentrations similar to those
found in plasma. Bactericidal concentrations of metronidazol