BUMETANIDE

For oral administration. Adults Normally a single dose of 1 mg given in the morning or early evening. A second dose can be given 6 to 8 hours later depending on patient response. In refractory oedema higher doses may be necessary, until a satisfactory diuretic response is obtained.

Paediatric population The medicinal product is not recommended for children as there is limited information on safety, efficacy and dosage in children. Elderly Dosage should be adjusted according to response. 5 mg per day may be sufficient in some elderly patients.

Reported reactions include abdominal pain, vomiting, dyspepsia, diarrhoea, stomach and muscle cramps, arthralgia, fatigue, hypotension, headache, dizziness, nausea, encephalopathy in patients with pre-existing hepatic disease, fluid and electrolyte depletion, dehydration, hyperuricaemia, raised blood urea and serum creatinine, hyperglycaemia, abnormalities of serum levels of hepatic enzymes, skin rashes, pruritus, urticaria, thrombocytopenia, gynaecomastia and painful breasts.

Bone marrow depression associated with the use of bumetanide has been reported rarely but it has not been definitely proven to be attributed to the drug. Hearing disturbance after administration of bumetanide is rare and reversible.

High dose therapy - In patients with severe chronic renal failure given high doses of bumetanide, there have been reports of severe generalised, muscoskeletal pain sometimes associated with muscle spasm, occurring 1 to 2 hours after administration and lasting up to 12 hours.

The lowest reported dose causing this type of adverse reaction was 5 mg by intravenous injection and the highest dose was 75 mg orally in a single dose. All patients recovered fully and there was no deterioration in their renal function.

The cause of this pain is uncertain but it may be as a result of varying electrolyte gradients at the cell membrane level. Experience suggests that the incidence of such reactions is decreased by initiating treatment at 5 - 10 mg daily and titrating upwards using a twice daily dosage regimen at doses of 20 mg per day or more.

4), the frequency of this is not known.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Very rapid mobilisation of oedema, particularly in the elderly, may cause sudden changes in cardiovascular pressure-flow relationships with circulatory collapse and should be borne in mind when bumetanide is given in high doses intravenously or orally.

Electrolyte disturbances may occur particularly in those patients taking a low-salt diet. Periodic checks of serum electrolyte levels, in particular sodium, potassium, chlorides and bicarbonates should be undertaken and where necessary replacement therapy instituted.

As with other diuretics, bumetanide may cause an increase in blood uric acid. Regular checks on urine and blood glucose should be made in diabetics and patients suspected of latent diabetes. Patients with chronic renal failure on high doses of bumetanide should remain under constant hospital supervision.

Encephalopathy may be precipitated in patients with pre-existing hepatic impairment. Toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS), which can be life-threatening or fatal, have been reported in relation to non-antibiotic sulphonamide containing products, including bumetanide.

Patients should be advised of the signs and symptoms of SJS and TEN and closely monitored for those. If signs and symptoms suggestive of these reactions appear, bumetanide should be withdrawn, and an alternative therapy should be considered.

If the patient has developed a serious reaction such as SJS or TEN, with the use of bumetanide, treatment with bumetanide must not be restarted in this patient at any time. Excipient(s) Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. Bumetanide can be used to induce diuresis in renal insufficiency. Therapy should be stopped if there is significant increase in blood urea levels or the onset of oliguria or anuria is observed during the treatment of severe renal disease.

Bumetanide is contra-indicated in hepatic coma, care should be taken in cases of severe electrolyte imbalance.