FUROSEMIDE-BAXTER

What it is

Furosemide-Baxter is a solution for injection containing furosemide 20 mg/2 mL and 50 mg/5 mL. It is formulated for intramuscular or intravenous use. Furosemide is a potent diuretic with rapid action that inhibits sodium and chloride absorption in the ascending limb of Henle's loop and in both the proximal and distal tubules, with high efficacy due to this unique site of action.

Approved indications

— Oedema associated with congestive heart failure, cirrhosis of the liver and renal disease including the nephrotic syndrome in adults, infants and children. — Adjunctive therapy in acute pulmonary oedema where intense and rapid onset of diuresis is desired. — Adjunctive therapy in cerebral oedema where intense and rapid onset of diuresis is desired.

Dosing overview

Intravenous doses should be given slowly. Therapy should be individualised according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response, with close medical supervision necessary.

Key safety warnings

Excessive diuresis may result in dehydration and reduction in blood volume with circulatory collapse and with the possibility of vascular thrombosis and embolism, particularly in elderly patients. Cases of reversible or irreversible tinnitus or hearing impairment have been reported, with furosemide ototoxicity usually associated with rapid injection or infusion, severe renal impairment, hypoproteinaemia, doses exceeding several times the usual recommended dose, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. Caution should be exercised when combining risperidone with furosemide or other potent diuretics; in risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%) compared to risperidone alone (3.1%) or furosemide alone (4.1%). Dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia. Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity; during long-term therapy, a high potassium diet is recommended and potassium supplements may be required, especially when high doses are used for prolonged periods.

Contraindications

Known hypersensitivity to furosemide or sulfonamides or any of the inactive ingredients. Complete renal shutdown; impaired renal function or anuria. Severe hypokalaemia, hyponatraemia, hypovolaemia, dehydration or hypotension must be regarded as contraindications until serum electrolytes, fluid balance and blood pressure have been restored to normal levels. In hepatic coma or precoma and conditions producing electrolyte depletion, furosemide therapy should not be instituted until the underlying conditions have been corrected or ameliorated. Breast-feeding or pregnant women. Do not administer furosemide to newborns presenting jaundice or to infants with conditions which might induce hyperbilirubinaemia or kernicterus because of furosemide's potential to displace bilirubin from albumin.

Regulatory history

Furosemide-Baxter 20 mg/2 mL and 50 mg/5 mL solution for injection were first listed on the Australian Register of Therapeutic Goods on 3 April 2009. The date of first approval was 25 November 2009.