Furosemide-WGR

What it is

Furosemide-WGR contains 40 mg of the active ingredient furosemide (frusemide). Furosemide-WGR 40 mg 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 alone or in combination with other antihypertensive agents in adults.

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. **Oedema:** 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 daily. The dose may be carefully titrated up to 400 mg per day (except in advanced renal failure) in patients with severe clinical oedematous states. Furosemide-WGR tablets should be taken orally on an empty stomach. **Hypertension:** The usual initial daily dose for hypertension is 80 mg, usually divided into 40 mg twice a day, and dosage should then be adjusted according to response.

Key safety warnings

Furosemide-WGR is a potent diuretic which, if given in excessive amounts, can lead to 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, 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. Potassium supplements may be required especially when high doses are used for prolonged periods. 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-WGR, 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 is contraindicated. Patients allergic to sulfonamides (for example, sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide (frusemide). 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 (frusemide) therapy should not be instituted until the underlying conditions have been corrected or ameliorated. Furosemide-WGR is contraindicated in breastfeeding or pregnant women.

Regulatory history

Furosemide-WGR 40 mg tablets were first listed on the ARTG on 28 June 2012.