Metronidazole tablet

Contraindications



Metronidazole is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.

In patients with trichomoniasis, Metronidazole is contraindicated during the first trimester of pregnancy. ( See Warnings.)


Information for patients



Alcoholic beverages should be avoided while taking metronidazole and for at least one day afterward. See Drug Interactions .

Patients should be counseled that antibacterial drugs including metronidazole should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When metronidazole is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by metronidazole or other antibacterial drugs in the future.


Geriatric use



No overall differences have been reported in safety and effectiveness between younger and older individuals, but greater sensitivity of some older individuals cannot be ruled out. Systemic exposure to the active metabolite, 2-hydroxymethyl metronidazole, is higher in the elderly.

Metronidazole is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Although decreased renal function does not alter the single dose pharmacokinetics of metronidazole, because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Plasma clearance of metronidazole is decreased in patients with decreased liver function. Therefore, in elderly patients, monitoring of serum levels may be necessary to adjust the metronidazole dose accordingly.


Adverse reactions



Two serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.

The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epigastric distress; and abdominal cramping. Constipation has also been reported.

The following reactions have also been reported during treatment with metronidazole:

Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candidawhich may occur during therapy.
Hematopoietic: Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia.
Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.
Central Nervous System: Convulsive seizures, peripheral neuropathy, dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness, and insomnia.
Hypersensitivity: Urticaria, erythematous rash, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever.
Renal: Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance.
Other: Proliferation of Candidain the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling "serum sickness". If patients receiving metronidazole drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing, or headache. A modification of the taste of alcoholic beverages has also been reported. Rare cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported.

Crohn's disease patients are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn's disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn's disease is not an approved indication for metronidazole.


How supplied



Metronidazole 250 mg tablets are unscored, round, white, debossed MP 45

Bottles of 20 unit of useNDC 53489-135-60
Bottles of 100NDC 53489-135-01
Bottles of 250NDC 53489-135-03

Metronidazole 500 mg tablets are unscored, capsule shaped, white, debossed MP 46

Bottles of 20 unit of useNDC 53489-136-60
Bottles of 100NDC 53489-136-01


Storage and handling



Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature]

Protect from light.

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.


References



1. Proposed standard: PSM-11 Proposed Reference Dilution Procedure for Antimicrobic Susceptibility Testing of Anaerobic Bacteria, National Committee for Clinical Laboratory Standards; and Sutter, et al.: Collaborative Evaluation of a Proposed Reference Dilution Method of Susceptibility Testing of Anaerobic Bacteria, Antimicrob. Agents Chemother. 16:495-502 (Oct.) 1979; and Tally, et al.: In VitroActivity of Thienamycin, Antimicrob. Agents Chemother. 14:436-438 (Sept.) 1978.

2. Ralph, E.D., and Kirby, W.M.M.:Bioassay of Metronidazole With Either Anaerobic or Aerobic Incubation, J.Infect. Dis. 132:587-591 (Nov.) 1975; or Gulaid, et al.: Determination of Metronidazole and Its Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography, Br. J. Clin. Pharmacol. 6:430-432, 1978.


Ingredients and appearance - Product information

Metronidazole tablet- Metronidazole

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-008
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Metronidazole ( UNII: 140QMO216E)( Metronidazole - UNII: 140QMO216E ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Crospovidone ( UNII: 68401960MK)
Hydrated silica ( UNII: Y6O7T4G8P9)
Magnesium stearate ( UNII: 70097M6I30)

Product Characteristics

Color white Score 1
Shape ROUND (TABLET) Imprint Code MP;45
Size 9 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-008-02 30 in 1 BLISTER PACK 2010/11/04
2 NDC: 49349-008-06 28 in 1 BLISTER PACK 2010/11/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA070772 USA 2010/11/04

Labeler - REMEDYREPACK INC.( 829572556)