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BUMETANIDE is a brand name for Bumetanide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bumetanide is indicated for the treatment of oedema associated with e.g. congestive heart failure, renal dysfunction including nephrotic syndrome and cirrhosis of the liver in adults. In oedema of renal or cardiac origin where high doses of a potent short - acting diuretic are required, Bumetanide 5 mg may be used in…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
The dose should be carefully titrated in each patient according to the patient’s response and the required therapeutic activity. As a general rule, in patients not controlled on lower doses, dosage should be started at 5mg daily and then increased by 5mg increments every 12-24h until the required response is obtained or until side effects appear.
Consideration should be given to a twice daily rather than a once daily dosage. Direct substitution of bumetanide for furosemide in a 1:40 ratio at high doses should be avoided. Treatment should be initiated at a lower equivalent dose and gradually increased at 5 mg increments.
Dosage in the elderly Adjust the dosage according to the response. 5 mg bumetanide per day may be sufficient in some elderly patients. Paediatric population Not recommended for children under 12 years of age as there is limited information on safety, efficacy and dosage in children.
Method of administration For oral use.
4). Adverse effects are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data): Blood and lymphatic system disorders Rare: Bone marrow depression associated with the use of bumetanide, but it has not been proven definitely to be attributed to the drug.
Not known: thrombocytopenia. Metabolism and nutrition disorders Common: dehydration. Uncommon: fluid and electrolyte depletion. Not known: hyperuricaemia, hyperglycaemia. Nervous system disorders Common: dizziness, headache. Not known: encephalopathy (in patients with pre-existing hepatic disease).
Ear and labyrinth disorders Uncommon: ear pain, vertigo.
Rare:
Hearing disturbance after administration of bumetanide, which is reversible. Vascular disorders Common: hypotension. Gastrointestinal disorders Common: nausea. Uncommon: diarrhoea. Not known: stomach cramps, abdominal pain, vomiting, dyspepsia.
Skin and subcutaneous tissue disorders Common: pruritis (in patients with liver disease).
Not Known:
Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN). Uncommon: urticaria. Not known: rash. Musculoskeletal and connective tissue disorders Not known: muscle cramps, arthralgia. Reproductive system and breast disorders Uncommon: painful breasts.
Not known: gynaecomastia. General disorders and administration site conditions Common: fatigue. Uncommon: chest discomfort. Investigations Not known: raised blood urea and serum creatinine, abnormalities of serum levels of hepatic enzymes Higher dose therapy: In patients with severe chronic renal failure given high doses of bumetanide, there have been reports of severe, generalised musculoskeletal pain sometimes associated with muscle spasm, occurring one or two hours after administration and lasting up to 12 hours.
Sudden changes in cardiovascular pressure-flow relationships, leading to circulatory collapse, can occur particularly in the elderly if the oedema is eliminated too rapidly. It is important to remember this when bumetanide is given in high doses, either orally or intravenously.
Patients with chronic renal failure on high doses of bumetanide should remain under constant hospital supervision. Patients on a low salt diet may suffer electrolyte imbalance. Serum electrolyte checks, in particular for sodium, potassium, chloride and bicarbonate, should be carried out on a regular basis and, where necessary, replacement therapy carried out.
Bumetanide may enhance the nephrotoxicity or ototoxicity of other drugs, particularly in patients with renal impairment. Bumetanide may precipitate encephalopathy in patients with hepatic impairment. Bumetanide may increase uric acid.
Blood glucose and blood uric acid should be measured periodically, especially in diabetics and those suspected of latent diabetes and in patients with gout. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
1. Oliguria. Anuria. Increase in blood urea. • Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase of blood urea or the development of oliguria or anuria during treatment of severe progressive renal disease are indications for stopping treatment with bumetanide.
Hepatic coma. Severe electrolyte imbalance. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The lowest reported dose causing this type of adverse reaction was 5 mg by intravenous injection and the highest 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 a result of varying electrolyte gradients at the cell membrane level. Experience suggests that the incidence of such reactions is reduced by initiating treatment at 5-10 mg daily and titrating upwards using a twice daily dosage regimen at doses of 20 mg or more.
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.