FRUSEMIX-M

What it is

FRUSEMIX-M is a furosemide tablet containing 40 mg of the active ingredient furosemide. The tablets are white, round and slightly convex with a score notch on one side.

Approved indications —

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

Dosing overview

FRUSEMIX-M tablets should be taken orally on an empty stomach.

Key safety warnings

Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis. 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, 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. Hypokalaemia may develop with furosemide, especially with brisk diuresis, when cirrhosis is present, during long-term therapy or during concomitant use of corticosteroids or adrenocorticotropic hormone (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. 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. Patients allergic to sulfonamides 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. FRUSEMIX-M is contraindicated in breastfeeding or pregnant women.

PBS listing

The 20 mg tablet strength is listed on the PBS with unrestricted and restricted items, with an ex-manufacturer price of A$2.50.

Regulatory history

FRUSEMIX-M was first listed on the ARTG on 28 June 2012 as a 20 mg tablet formulation under licence category RE, sponsored by Arrotex Pharmaceuticals.