metronidazole- Metronidazole tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

Metronidazole (UNII: 140QMO216E) (metronidazole - UNII:140QMO216E)

Διαθέσιμο από:

Watson Labs

INN (Διεθνής Όνομα):

Metronidazole

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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). 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. 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 has been attempted is an individual one. In making this decision, it should be noted that there i

Περίληψη προϊόντος:

Metronidazole Tablets USP 250 mg are 11/32״ , unscored, round, white to off-white tablets imprinted DAN and 5540 supplied in bottles of 50, 100, 250, 500 and 1000. Metronidazole Tablets USP 500 mg are 17/32״ , scored, round, white to off-white tablets imprinted DAN and 5552 supplied in bottles of 50, 100, 250, 500 and 1000. Dispense in a well-closed, light-resistant container with child-resistant closure. Store below 86°F (30°C). Protect from light.

Αρχείο Π.Χ.Π.

METRONIDAZOLE- METRONIDAZOLE TABLET
WATSON LABS
----------
METRONIDAZOLE TABLETS USP
REVISED: JULY 2004
RX ONLY
WARNING
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.
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 is an oral synthetic antiprotozoal and antibacterial
agent, 1-(β-hydroxyethyl)-2-methyl-5-
nitroimidazole. The structural formula is represented below:
C H N O
M.W. 171.15
Each tablet, for oral administration, contains 250 mg or 500 mg of
metronidazole. In addition, each tablet
contains the following inactive ingredients: colloidal silicon
dioxide, crospovidone, hydrogenated
vegetable oil and microcrystalline cellulose.
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 to 80% of the
dose), with fecal excretion accounting for 6 to 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/1.73 m .
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