APO-FRUSEMIDE

What it is

APO-FRUSEMIDE contains 40 mg of the active ingredient furosemide (frusemide). APO-FRUSEMIDE 40mg tablets are white, round tablets, slightly convex with a score notch on one side.

Approved indications

— Treatment of oedema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome in adults. — Treatment of hypertension in adults, alone or in combination with other antihypertensive agents.

Dosing overview

For oedema, therapy should be individualised according to patient's response and titrated to gain maximal therapeutic response with the minimum dose possible to maintain that diuretic response. The usual initial daily dose is 20 to 80 mg given as a single dose; if the diuretic response is not satisfactory, increase this dose by increments of 20 to 40 mg, not sooner than six to eight hours after the previous dose, until the desired diuretic effect is obtained. This individually determined dose should be given once or twice (e.g. at 8 am and 2 pm) daily. The dose of APO-FRUSEMIDE may be carefully titrated up to 400 mg/day (except in advanced renal failure) in those patients with severe clinical oedematous states. For hypertension, therapy should be individualised according to the patient's response and titrated to gain maximal therapeutic response with the minimum dose possible to maintain that therapeutic response. The usual initial daily dose of APO-FRUSEMIDE for hypertension is 80 mg, usually divided into 40 mg twice a day, then adjusted according to response.

Key safety warnings

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis, and 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; usually, reports indicate that furosemide ototoxicity is 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. 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, with particular caution necessary when the patient is on digitalis glycosides or on potassium depleting steroids. Symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension.

Contraindications

Known hypersensitivity to furosemide or sulfonamides or any of the inactive ingredients is a contraindication. Patients allergic to sulfonamides (e.g. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide. Complete renal shutdown, impaired renal function or anuria are contraindications; if increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide. 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. APO-FRUSEMIDE is contraindicated in breastfeeding or pregnant women.

PBS listing

APO-FRUSEMIDE 40 mg tablets are listed on the PBS with 2 items and restriction type of both restricted and unrestricted, at an ex-manufacturer price of A$2.50.

Regulatory history

APO-FRUSEMIDE furosemide 40 mg tablets were first listed on the ARTG on 28 June 2012.