ARTG Entry
LASIX
ARTG entry for LASIX (furosemide), ARTG 232815 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Sanofi-Aventis
- Active ingredient: furosemide
- Therapeutic area: Cardiology
What it is
LASIX contains furosemide, a sulphonamide-type loop diuretic . Furosemide is a potent diuretic that inhibits sodium reabsorption in the ascending limb of Henle's loop and in both the proximal and distal tubules .
Approved indications
High doses of furosemide may be used as an adjuvant treatment of oliguria and in the promotion of diuresis in the treatment of oedema; in selected patients with acute renal failure, for example in the post-operative phase and in association with septic infections; in selected patients with chronic renal failure with fluid retention, both in the pre-dialysis phase and when dialysis has become unavoidable, especially in the presence of acute pulmonary oedema; in selected patients with the nephrotic syndrome with severe impairment of renal function for example in chronic glomerulonephritis, lupus erythematous and Kimmelstiel-Wilson syndrome .
Dosing overview
For oedema, therapy should be individualised according to the patient's response. The usual initial daily dose is 20 to 80 mg given as a single dose. A prompt diuresis ordinarily ensues and the starting dose can then be maintained or even reduced. If a satisfactory diuresis has not occurred within 6 hours, succeeding doses should be increased by increments of 20 to 40 mg after the previous dose until the desired diuretic effect is obtained . For hypertension, therapy should be individualised according to the patient's response, with a dose of 20 to 40 mg twice daily . If conventional doses fail to produce an adequate diuresis, an initial dose of 250 mg may be given, increased if necessary in steps of 250 mg every 4 to 6 hours until adequate diuresis of at least 2.5 L per day is achieved, with a maximum daily dose of 1000 mg .
Key safety warnings
Cases of reversible or irreversible tinnitus and deafness have been reported, usually associated with rapid injection, severe renal impairment, hypoproteinaemia, doses exceeding several times the usual recommended dose, or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs . Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity . Hypokalaemia may develop with furosemide especially with brisk diuresis, when cirrhosis is present, during long-term therapy or during concomitant use of corticosteroids or ACTH. Interference with adequate oral electrolyte intake will also contribute to hypokalaemia. Digitalis therapy may exaggerate metabolic effects of hypokalaemia, especially with reference to myocardial effects . Electrolyte depletion may occur during therapy, especially in patients receiving higher doses and a restricted salt intake. All patients receiving furosemide therapy should be observed for signs of fluid or electrolyte imbalance including hyponatraemia, hypochloraemic alkalosis, hypokalaemia, hypomagnesaemia or hypocalcaemia. Periodic determinations of serum electrolytes should be performed at appropriate intervals, as well as creatinine and blood urea and carbon dioxide content . Due to possible hypotension, the patient's ability to drive or operate machinery may be impaired, especially at the commencement of therapy .
Contraindications
LASIX is contraindicated in patients with known hypersensitivity to furosemide or sulfonamides or to any of the components of the medicine. Patients allergic to sulfonamides may show cross-sensitivity to furosemide . Complete renal shutdown, impaired renal function or anuria are contraindications. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued . In hepatic coma or precoma and conditions producing electrolyte depletion, furosemide therapy should not be instituted until the underlying condition has been corrected or ameliorated. Severe hypokalaemia, hyponatraemia, hypovolaemia, dehydration or hypotension must be regarded as contraindications until serum electrolytes and fluid balance and blood pressure have been restored to normal levels . LASIX should not be administered to breastfeeding or pregnant women . Furosemide should not be administered 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 .
PBS listing
The oral solution 10 mg per mL, 30 mL presentation has 2 PBS items with one unrestricted and one restricted listing, with an ex-manufacturer price of A$25.80 as of 2026-05-01. The injection 20 mg in 2 mL has 2 PBS items with unrestricted restriction, with an ex-manufacturer price of A$2.87 as of 2026-05-01 .
Regulatory history
LASIX furosemide 20 mg per 2 mL injection ampoule (ARTG 12404) was first listed on 1991-08-01, and LASIX HIGH DOSE furosemide 250 mg per 25 mL injection ampoule (ARTG 12408) was first listed on 1991-08-01 . LASIX furosemide 10 mg per mL oral liquid bottle (ARTG 232815) was first listed on 2015-05-18 .