SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Bumetanide 1mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of bumetanide
For excipients, see 6.1.
White, circular, flat uncoated tablet. Engraving: 7B1: plain with breakline.
Bumetanide is indicated when diuretic therapy is required in the treatment of oedema,
such as that associated with congestive heart failure, cirrhosis of the liver and renal
disease including nephrotic syndrome. Bumetanide 1 mg tablets are indicated in the
treatment of oedema, and treatment of arterial hypertension in adults. Bumetanide 5
mg tablets are indicated in the treatment of acute and chronic renal failure in adults
and may be used in oedema of cardiac or renal origin where high doses of a potent
short acting diuretic are required.
Posology and method of administration
For oral administration.
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.
information on safety, efficacy and dosage in children.
Dosage should be adjusted according to response. A dose of 0.5 mg per day may be
sufficient in some elderly patients.
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 and in patients hypersensitive to the drug.
Special warnings and precautions for use
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
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
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.
Lactose warning: Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should not take this
Interaction with other medicinal products and other forms of interaction
Like other diuretics, bumetanide shows a tendency to increase potassium excretion
which can lead to an increase in the sensitivity of the myocardium to the toxic effects
of digitalis. Therefore, the dose of bumetanide may need adjustment when given in
conjunction with cardiac glycosides.
Bumetanide may potentiate the effects of antihypertensive drugs. Therefore, patients
taking these drugs should be monitored and dosage adjustment should occur where
Certain non-steroidal anti-inflammatory drugs have been shown to antagonise the
action of diuretics.
Bumetanide should be used with caution in patients already receiving nephrotoxic or
In common with other diuretics, serum lithium levels may be increased when lithium
is given concomitantly with bumetanide. This may result in increased lithium
toxicity, including increased risk of cardiotoxic and neurotoxic effects of lithium.
Therefore, it is recommended that lithium levels are carefully monitored and where
necessary the lithium dosage is adjusted in patients receiving this combination.
Fertility, pregnancy and lactation
Avoid the use of bumetanide in the first trimester of pregnancy.
It is unknown whether bumetanide can be excreted into breast milk, therefore, its use
during lactation is not recommended. If the drug is absolutely necessary for the
mother, nursing mothers should either stop breast feeding or observe the infant for
any adverse effects.
Effects on ability to drive and use machines
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
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
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
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
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. Healthcare professional are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
Symptoms are those caused by excessive diuresis. The stomach should be
emptied by gastric lavage or emesis. General measures should be taken to
ATC Code: C03C A02 (sulfonamides, plain)
Bumetanide is a potent high ceiling loop diuretic with a rapid onset and short duration
of action. The primary site of action is the ascending limb of the loop of Henlé. It
natriuretic action observed.
After oral administration of 1mg of bumetanide, diuresis begins within 30 minutes with a
peak effect between one and two hours. The diuretic effect is virtually complete in three
hours after a 1mg dose.
Bumetanide is well absorbed after oral administration with bioavailability reaching
between 80 and 95%. The elimination half-life ranges from between 0.75 to 2.6
hours. No active metabolites are known. Renal excretion accounts for approximately
half the clearance with hepatic excretion responsible for the other half. There is an
increase in half-life and a reduced plasma clearance in the presence of renal or hepatic
disease. In patients with chronic renal failure, the liver takes more importance as an
excretory pathway although the duration of action is not markedly prolonged.
In neonates and infants, elimination appears slower than in older paediatric patients
and adults, possibly because of immature renal and hepatobiliary functions. Mean
serum elimination half-life decreases during the first month of life from 6 hours in
neonates to 2.4 hours in infants 1 month of age.
Mean serum elimination half-life is 2.5 and 1.5 hours in infants younger than 2
months of age and in those 2–6 months of age, respectively. The apparent elimination
half-life may be prolonged to approximately 6 hours (with a range up to 15 hours)
after IV administration in premature or full-term neonates with respiratory disorders.
Data for younger children, including neonates and infants, is not sufficient to allow
for dosing recommendations, see 4.2.
Preclinical safety data
bumetanide has been established after many years of clinical use. Please refer to
List of excipients
Microcrystalline cellulose (E460)
Sodium starch glycollate (Type A) (E576)
Magnesium stearate (E572)
Special precautions for storage
Do not store above 25°C. Store in the original container.
Nature and contents of container
HDPE containers with LDPE lids in packs of 14, 20, 21, 28, 30, 50, 56, 60, 84, 100,
112, 120, 168, 250, 500, 1000 & 5000.
PVdC coated PVC film with hard temper aluminium foil blister strips in packs of 7,
10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 & 168
Not all pack sizes may be marketed.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
TEVA UK Limited,
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT