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TEVA-NITROFURANTOIN is a brand name for Nitrofurantoin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE TEVA-NITROFURANTOIN is indicated for the treatment of urinary tract infections, e.g., cystitis, when due to susceptible strains of E. coli, enterococci, S. aureus and certain susceptible strains of Klebsiella species, Enterobacter species, and Proteus species. It is not indicated for treatment of…
Verbatim from this product's HC label. Tap a section to expand.
Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications to therapy with this drug. Treatment in these patient carries an increased risk of toxicity because of impaired excretion of the drug.
For the same reason, the drug is much less effective under these circumstances. The drug is contraindicated in pregnant patients during labour and delivery, or when the onset of labor is imminent, and in infants under one month of age because of the possibility of hemolytic anemia in the fetus or the newborn infant due to their immature erythrocyte enzyme systems (glutathione instability).
TEVA-NITROFURANTOIN is also contraindicated in those patients with known hypersensitivity to nitrofurantoin. WARNINGS Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin products.
(See ADVERSE REACTIONS): If these reactions occur, the drug should be withdrawn and appropriate measures taken. Reports have cited pulmonary reactions as a contributing cause of death. Chronic pulmonary reactions (diffuse interstitial pneumonitis or pulmonary fibrosis, or both) can develop insidiously.
These reactions occur rarely and generally in patients receiving therapy for six months or longer. Close monitoring of the pulmonary condition of patients receiving long- term therapy, is warranted and requires that the benefits of therapy be weighed against potential risks.
(See ADVERSE REACTIONS). 6 Hepatic reactions, including hepatitis, hepatic necrosis, cholestatic jaundice and chronic active hepatitis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in liver function.
If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures taken. Peripheral neuropathy (including optic neuritis), may occur with nitrofurantoin therapy; this may become severe or irreversible. Fatalities have been reported.
Predisposing conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating disease may enhance such occurrence.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients receiving long-term therapy should be monitored periodically for changes in renal function. If numbness or tingling occurs, discontinue use. Cases of hemolytic anemia of the primaquine sensitivity type have been induced by nitrofurantoin.
The hemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. This deficiency is found in 10% of blacks and a small percentage of ethnic groups of Mediterranean and Near-Eastern origin.
Any sign of hemolysis is an indication to discontinue the drug. Hemolysis ceases when the drug is withdrawn. Pseudomonas is the organism most commonly implicated in superinfections in patients with nitrofurantoin preparations.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Nitrofurantoin presented evidence of carcinogenic activity in female B6C3F1 mice as shown by increased incidences of tubular adenomas, benign mixed tumor and granulosa cell tumor of the ovary. In male F344/N rats, there were increased incidences of uncommon kidney tubular cell neoplasms, osteosarcomas of the bone and neoplasms of the subcutaneous tissue.
In one study involving three subcutaneous 7 injections of 75 mg/kg nitrofurantoin to pregnant female mice, lung papillary adenomas were observed in the F1 generation. 5 weeks or to female Sprague-Dawley rats for 75 weeks. Two chronic rodent bioassays utilizing male and female Sprague-Dawley rats and 2 chronic bioassays in Swiss mice and BDF1 mice revealed no evidence of carcinogenicity.
Nitrofurantoin has demonstrated mutagenic potential in a variety of laboratory assays conducted in vitro with mammalian and non-mammalian cells exposed to therapeutically attainable and higher concentrations. Point and possibly other types of mutations were observed in bacteria, yeast and fungi.
Damage to DNA or inhibition of DNA synthesis was produced in human fibroblasts and lymphocytes, and Chinese hamster ovaries and lung fibroblasts. In vivo tests on rodents utilizing a wide range of doses demonstrated similar potential.
DNA damage to liver, lung, spleen and kidney were observed in rat (alkaline elution test), immature red blood cells (rat micronucleus test) and sperm (H-test in mouse). Some test results were negative such as the sex-linked recessive lethal assay in Drosophilia where nitrofurantoin was administered by feeding or injection.
The significance of the carcinogenicity and mutagenicity findings relative to the therapeutic use of nitrofurantoin in humans is unknown. Because of the potential toxicity of nitrofurantoin when used for long-term therapy, the benefits of long-term therapy should be weighed against potential risks (see DOSAGE AND ADMINISTRATION section for prescribing information).
The administration of high doses of nitrofurantoin to rats causes temporary spermatogenic arrest, which is reversible on discontinuing the drug. Doses of 10 mg/kg/day or greater in healthy 8 human males may, in certain unpredictable instances produce slight to moderate spermatogenic arrest with a decrease in sperm count.
Susceptibility/Resistance:
Development of Drug Resistant Bacteria: Prescribing TEVA-NITROFURANTOIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug- resistant bacteria.
Clostridium difficile-associated diarrhea:
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, and may range in […]