METRONIDAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Symptomatic   Trichomoniasis. Metronidazole tablets, USP 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, USP 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 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 is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets, USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic   Bacterial   Infections. Metronidazole tablets, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B.   fragilis group ( B.   fragilis , B.   distasonis , B.   ovatus , B.   thetaiotaomicron , B.   vulgatus ), Clostridium species, Eubacterium species, Peptococcus   species , and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B.   fragilis group, Clostridium species, Peptococcus   species , Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B.   fragilis group, Clostridium species, Peptococcus   species , Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B.   fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B.   fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B.   fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B.   fragilis group. ENDOCARDITIS caused by Bacteroides species including the B.   fragilis group. 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Metronidazole Tablets is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis, Metronidazole Tablets is contraindicated during the first trimester of pregnancy (see PRECAUTIONS ). Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS, Drug Interactions ). Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS, Drug Interactions ). Metronidazole tablets are contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome (see ADVERSE REACTIONS) .

Product summary:

Metronidazole Tablets USP, 500 mg are white to off-white, oval shaped, biconvex, film coated tablets debossed with '851' on one side and plain on other side and are supplied as follows: NDC: 70518-2663-00 NDC: 70518-2663-01 NDC: 70518-2663-02 NDC: 70518-2663-03 NDC: 70518-2663-04 NDC: 70518-2663-05 NDC: 70518-2663-06 NDC: 70518-2663-07 NDC: 70518-2663-08 PACKAGING: 4 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 14 in 1 BOTTLE PLASTIC PACKAGING: 4 in 1 BOTTLE PLASTIC PACKAGING:28 in 1 BOTTLE PLASTIC PACKAGING: 4 in 1 BOTTLE PLASTIC PACKAGING: 100 in 1 BOTTLE PLASTIC Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (USP). Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE- METRONIDAZOLE TABLET
REMEDYREPACK INC.
----------
METRONIDAZOLE TABLETS, USP
RX ONLY
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
USAGEsection
below.
DESCRIPTION
Metronidazole tablets, 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 USP is a white to pale yellow, crystalline powder. It is
sparingly soluble in
water and alcohol; slightly soluble in ether and chloroform; soluble
in dilute hydrochloric
acid.
Each metronidazole tablet, USP intended for oral administration
contains 250 mg or 500
mg of metronidazole. In addition, each tablet contains the following
inactive ingredients:
colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl
cellulose,
microcrystalline cellulose and stearic acid. Additionally each tablet
contains opadry II
white 02F580003 which contains hypromellose, polyethylene glycol, talc
and titanium
dioxide.
CLINICAL PHARMACOLOGY
ABSORPTION
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; howev