UREX

What it is

UREX contains furosemide (frusemide) 40 mg as the active ingredient. UREX 40 mg 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

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. It is recommended that UREX tablets 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 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 as with any other potent diuretic, especially with brisk diuresis, when cirrhosis is present, during long-term therapy or during concomitant use of corticosteroids or adrenocorticotropic hormone (ACTH). Excessive loss of potassium in patients receiving cardiac glycosides may precipitate digitalis toxicity; potassium supplements may be required especially when high doses are used for prolonged periods, and particular caution with potassium is 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 (frusemide) 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; 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. Breastfeeding or pregnancy.

Regulatory history

UREX furosemide 40 mg tablet was first listed on the ARTG on 17 January 1992.