METRONIDAZOLE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

State of Florida DOH Central Pharmacy

DCI (Dénomination commune internationale):

METRONIDAZOLE

Composition:

METRONIDAZOLE 500 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Metronidazole tablets are 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 tablets are 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

Descriptif du produit:

Metronidazole tablets are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Protect from light.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

METRONIDAZOLE - METRONIDAZOLE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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METRONIDAZOLE TABLETS USP, 250 MG AND 500 MG
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 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
Metronidazole 250 mg and 500 mg tablets, for oral administration,
contain the inactive ingredients:
colloidal silicon dioxide, hydroxypropyl cellulose, lactose
(anhydrous), microcrystalline cellulose,
sodium starch glycolate, and stearic acid.
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
6
9
3
3
2
to plasma proteins. Both the pare