METRONIDAZOLE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aidarex Pharmaceuticals LLC

INN (Medzinárodný Name):

METRONIDAZOLE

Zloženie:

METRONIDAZOLE 500 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Symptomatic Trichomoniasis Metronidazole tablets USP 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). Asymptomatic Trichomoniasis Metronidazole tablets USP 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. 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

Prehľad produktov:

Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70”  on the other side and are packaged in bottles of 14, 20, 21 and 30. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Watson Pharma, Inc. Parsippany, NJ  07054 USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: April 2013

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

METRONIDAZOLE- METRONIDAZOLE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
METRONIDAZOLE TABLETS USP
250 MG AND 500 MG
REVISED: APRIL 2013
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of metronidazole
tablets USP and other antibacterial drugs, metronidazole tablets USP
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:
Metronidazole 250 mg and 500 mg tablets USP, 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-(ß-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-
2
hydroxymethyl metabolite also being present. Less than 20% of the
circulating metronidazole is bound
to plasma proteins. Both the par