UREMIDE

What it is

UREMIDE contains furosemide 40 mg as the active ingredient. UREMIDE 40mg tablets are white, round tablets, slightly convex with a score notch on one side. The tablets contain lactose monohydrate as an excipient with known effect.

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, used alone or in combination with other antihypertensive agents.

Dosing overview

Therapy should be individualised according to patient response and titrated to gain maximal therapeutic response with the minimum dose possible to maintain that diuretic response. For oedema, the usual initial daily dose is 20 to 80 mg given as a single dose. If the diuretic response is not satisfactory, the dose should be increased 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. The dose may be carefully titrated up to 400 mg/day (except in advanced renal failure) in patients with severe clinical oedematous states. For hypertension, the usual initial daily dose is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response, and if response is not satisfactory, other antihypertensive agents should be added. UREMIDE 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, 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, and furosemide ototoxicity is 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. Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity, and during long-term therapy a high potassium diet is recommended, with potassium supplements required especially when high doses are used for prolonged periods. 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. In elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone compared to treatment with risperidone alone or furosemide alone.

Contraindications

Known hypersensitivity to furosemide or sulfonamides or any of the inactive ingredients is a contraindication. Patients allergic to sulfonamides (such as sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide. Complete renal shutdown, impaired renal function or anuria are contraindications. 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. Furosemide is contraindicated in breastfeeding or pregnant women.

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

UREMIDE 40 furosemide 40 mg tablets were first listed on the ARTG on 20 September 1991. A 20 mg tablet formulation was subsequently listed on 5 February 2024.