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PRO-FUROSEMIDE is a brand name for Furosemide (also known as Frusemide), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE..................................................................................... 2 CONTRAINDICATIONS ....................................................................................................... 3 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
PRO-FUROSEMIDE (furosemide) is contraindicated in: Patients who are hypersensitive to furosemide, sulfonamide-derived drugs or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
g. sulfonamide antibiotics or sulfonylureas) may show cross- sensitivity to furosemide. Patients with complete renal shutdown. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, the drug should be discontinued.
Patients with hepatic coma and precoma or in states of electrolyte depletion until the basic condition is improved or corrected. Therapy with PRO-FUROSEMIDE should not be initiated in these patients (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic section).
Severe hyponatremia, hypokalemia, hypovolemia, dehydration or hypotension must be regarded as contraindications until serum electrolytes and fluid balance and blood pressure have been restored to normal levels (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections).
) with the potential of causing hyperbilirubinemia and possibly kernicterus. Women must not breast-feed if they are treated with furosemide (see WARNINGS AND PRECAUTIONS section). WARNINGS AND PRECAUTIONS General PRO-FUROSEMIDE IS A POTENT DIURETIC WHICH IF GIVEN IN EXCESSIVE AMOUNTS CAN LEAD TO A PROFOUND DIURESIS WITH WATER AND ELECTROLYTE DEPLETION.
THEREFORE, CAREFUL MEDICAL SUPERVISION IS REQUIRED, AND DOSE AND DOSE SCHEDULE HAVE TO BE ADJUSTED TO THE INDIVIDUAL PATIENT'S NEEDS (SEE DOSAGE AND ADMINISTRATION). All patients receiving PRO-FUROSEMIDE therapy should be observed for signs and symptoms of fluid or electrolyte imbalance, hyponatremia, hypochloremic alkalosis, hypovolemia, hypomagnesemia, or hypocalcemia: dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oligourea, tachycardia, arrhythmia, or gastro-intestinal disturbances such as nausea and vomiting, increases in blood glucose and alteration in glucose tolerance tests.
During long-term therapy a high-potassium diet is recommended. Potassium supplements may 4 be required especially when high doses are used for prolonged periods. g. g. digitalis preparations and drugs inducing QT interval prolongation syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Furosemide in Canada.
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Particular caution with potassium levels is necessary when the patient is on digitalis glycosides, potassium-depleting steroids, or in the case of infants and children. Potassium supplementation, diminution in dose, or discontinuation of furosemide therapy may be required.
Since rigid sodium restriction is conducive to both hyponatremia and hypokalemia, strict restriction in sodium intake is not advisable in patients receiving furosemide therapy. Urinary outflow must be secured. Patients with urinary outflow require careful monitoring- especially during the initial stages of treatment (see ADVERSE REACTIONS-Post-Market Adverse Drug Reactions-Renal and urinary disorders section).
1%; mean age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings. No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed.
Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone.
Irrespective of treatment, dehydration was an overall risk factor for mortality (see CONTRAINDICATIONS section) and should therefore be avoided in elderly patients with dementia.
Carcinogenesis and Mutagenesis Carcinogenicity:
Furosemide in the approximate amount of 200 mg/kg body weight daily was administered to female mice and rats over a 2-year period with their diet. An increased incidence of mammary adenocarcinoma was noted in the mice, but not in the rats.
These tumors occurred with a positive trend, and the incidence in the high dose group was increased compared to the control, in addition, the high-dose rate was about five-fold over the historical rate. These tumors are considered to be associated with furosemide administration.
This dose is considerably greater than the therapeutic dose administered in human patients. In a carcinogenicity study, rats were administered furosemide in daily doses of 15 and 30 mg/kg body weight. Male rats in the 15 mg/kg-dose category, but not in the 30 mg/kg-dose category, showed a marginal increase in uncommon tumours.
Mutagenicity:
In in-vitro tests on bacteria and mammalian cells, both positive and negative results have been obtained. Induction of gene and chromosome mutations, however, has been observed only where furosemide reached cytotoxic concentrations.
5 Ear/Nose/Throat Cases of tinnitus and reversible deafness have been reported. There have also been some reports of cases, the majority in children undergoing renal transplantation, in which permanent […]