Bumetanide 1mg tablets

Main information

  • Trade name:
  • Bumetanide 1mg tablets
  • Dosage:
  • 1mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Bumetanide 1mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02020200

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00289/0322
  • Last update:
  • 29-01-2019

Summary of Product characteristics: dosage, interactions, side effects

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Bumetanide 1mg Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 1 mg of bumetanide

For excipients, see 6.1.

3.

PHARMACEUTICAL FORM

Tablet

White, circular, flat uncoated tablet. Engraving: 7B1: plain with breakline.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

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.

4.2

Posology and method of administration

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

medicinal

product

recommended

children

there

limited

information on safety, efficacy and dosage in children.

Elderly

Dosage should be adjusted according to response. A dose of 0.5 mg per day may be

sufficient in some elderly patients.

4.3

Contraindications

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.

4.4

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

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.

Lactose warning: Patients with rare hereditary problems of galactose intolerance, the

Lapp lactase deficiency or glucose-galactose malabsorption should not take this

medicine.

4.5

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

necessary.

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

ototoxic drugs.

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.

4.6

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.

4.7

Effects on ability to drive and use machines

None known.

4.8

Undesirable effects

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

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

cell

membrane

level.

Experience

suggests

that

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.

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.

4.9.

Overdose

Symptoms are those caused by excessive diuresis. The stomach should be

emptied by gastric lavage or emesis. General measures should be taken to

restore

blood

volume,

maintain

blood

pressure

correct

electrolyte

disturbance.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

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

exerts

inhibitory

effects

electrolyte

reabsorption

causing

diuretic

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.

5.2

Pharmacokinetic properties

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.

5.3

Preclinical safety data

Preclinical

information

been

included

because

safety

profile

bumetanide has been established after many years of clinical use. Please refer to

Section 4.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose monohydrate

Microcrystalline cellulose (E460)

Maize starch

Povidone (E1201)

Sodium starch glycollate (Type A) (E576)

Magnesium stearate (E572)

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf life

18 months.

6.4

Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5

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.

6.6

Special precautions for disposal

Not applicable.

7

MARKETING AUTHORISATION HOLDER

TEVA UK Limited,

Brampton Road

Hampden Park

Eastbourne

East Sussex

8.

MARKETING AUTHORISATION NUMBER

PL 00289/0322

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

12/08/2003

10

DATE OF REVISION OF THE TEXT

10/01/2019