Bumetanide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing 1mg bumetanide
Tablets containing 5mg bumetanide
Oral solution containing 200 micrograms / ml bumetanide
Drugs List
Therapeutic Indications
Uses
Treatment of oedema, such as that associated with:
Cardiac failure
Hepatic cirrhosis
Renal disease (including nephrotic syndrome)
Dosage
A twice daily dose regime should be considered especially where high doses are given.
Adults
1mg to be taken in the morning (or early evening). A second dose can be given 6 to 8 hours later if necessary. Increase dose until adequate diuresis is obtained.
In severe cases, (e.g. oedema of cardiac or renal origin), higher doses may be necessary, and 5mg daily may be given. This can be increased, if necessary, by 5mg every 12 to 24 hours until an adequate response is obtained or side effects appear.
Elderly
Adjust dosage according to response. A daily dose of 500 micrograms may be sufficient in some elderly patients.
Children
Children aged 12 to 18 years
(See Dosage; Adult)
Children aged 1 month to 12 years (unlicensed)
15 to 50 micrograms/kg given one to four times daily. Maximum dose is 2mg per dose or 5mg per day.
Patients with Renal Impairment
Use with caution.
Higher doses may be needed to induce diuresis in renal insufficiency.
Treatment should be stopped if increased blood urea, oliguria or anuria develop.
Patients with Hepatic Impairment
Use with caution. No additional dosage information available. Hepatic impairment may increase risk of encephalopathy, hypokalaemia and hypomagnesaemia.
Additional Dosage Information
In most patients, a 1mg dose of bumetanide exerts a similar effect to 40mg furosemide.
This 1:40 relationship is not valid for higher doses of bumetanide.
After oral administration, diuresis begins within about 30 minutes to an hour, with a peak effect between 1 and 2 hours. The diuretic effect lasts about 4 hours but may be prolonged to 6 hours after high doses.
Administration
For oral administration.
Contraindications
Raised blood urea
Oliguria or anuria
Hepatic coma
Breast feeding ( See Lactation section )
Neonates
Hypovolaemia
Hypotension
Severe hypokalaemia
Severe hyponatraemia
Precomatose states associated with liver cirrhosis
Renal impairment due to hepatotoxic drugs
Renal impairment due to nephrotoxic drugs
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Correct hypovolaemia and hypotension before initiation of treatment.
NSAIDs may antagonise the action of diuretics. Patients should be advised not to take NSAIDs unless advised by a clinician.
Rapid mobilisation of oedema may cause circulatory collapse, particularly in elderly patients. This should be born in mind when bumetanide is given in high doses.
Electrolyte disturbances may occur, particularly in patients with a low salt diet.
Use with caution in patients suspected of electrolyte imbalances
Regularly monitor serum electrolytes, particularly sodium, potassium, chloride and bicarbonate.
Supplemental electrolytes may be required.
Diabetes mellitus - monitor blood and urinary glucose in patients with diabetes mellitus and those suspected of latent diabetes.
Chronic renal failure patients should remain under constant hospital supervision.
Discontinue if blood urea increases or oliguria/anuria occur during treatment for oedema due to renal insufficiency.
Use in caution in patients taking nephrotoxic or ototoxic drugs.
In prostatic hypertrophy urinary retention may occur. This can be avoided by the use of low doses and less potent diuretics initially. An adequate urinary output should be established before initiating treatment.
May exacerbate gout.
May cause dizziness or fatigue, patients should not drive or operate machinery if they experience these effects.
Hepatic impairment - ( see Dosage - hepatic impairment).
Renal impairment - ( see Dosage - renal impairment).
Pregnancy - (see Pregnancy section).
Elderly (see Dosage Elderly ).
Children 1 month - 12 years (see Dosage Children ).
Can cause a positive anti doping test in athletes.
Some formulations contain lactose and should be avoided in patients with galactosaemia, glucose-galactose malabsorption syndrome and lactose intolerance.
Some formulations contain sorbitol and should be avoided in patients with hereditary fructose intolerance.
Use with caution in patients with a family history of long QT syndrome and patients with a history of torsade de pointes.
Consider monitoring ECG in patients at risk of QT prolongation.
Correct electrolyte disorders before treatment.
Pregnancy and Lactation
Pregnancy
Diuretics are no longer part of the standard therapy for hypertension and oedema during pregnancy. They should only be used for particular indications. Bumetanide has been recommended for the treatment of nephrotic syndrome in pregnancy.
Diuretics can reduce the plasma volume and lead to a reduced perfusion of the placenta.
There is inadequate data on the use of this drug in pregnancy so it is not generally recommended.
A study on 44 newborns exposed to bumetanide during the first trimester showed 2 major cardiovascular defects when 0.4 were expected. Caution should therefore especially be applied in this trimester.
Tests with bumetanide on rats, rabbits, mice and hamsters have shown a low teratogenic risk. Rabbits given doses of 3.4 times the maximum human therapeutic dose (MTHD) showed slightly embryocidal effects (Briggs, 2008).
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Contraindicated during breastfeeding. Safety has not been established.
Bumetanide and other diuretics are thought to suppress lactation and it is not known whether the drug is excreted in breast milk, so the manufacturer advises avoidance if possible. Low doses in mothers whose lactation is well established are unlikely to suppress lactation.
Schaefer (2007) concludes that single doses of bumetanide do not require limitation of breastfeeding, but therapy should be changed.
If use considered essential, then discontinue breastfeeding while on therapy or observe infant for adverse effects.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Licensed in neonates - No.
Effects on Ability to Drive and Operate Machinery
Patients who experience dizziness or fatigue should not drive or operate machinery.
Counselling
Advise patient that the diuretic effect of 1mg dose is complete within about 3 hours so that doses should not be taken less than 3 to 4 hours before retiring for the night.
Advise patients not to drive or operate machinery if they experience dizziness or fatigue.
Advise patients not to take NSAIDs unless advised by a clinician.
Side Effects
Abdominal pain
Vomiting
Dyspepsia
Diarrhoea
Abdominal cramps
Muscle cramps
Arthralgia
Dizziness
Fatigue
Hypotension
Headache
Nausea
Encephalopathy
Fluid and electrolyte disturbances
Dehydration
Hyperuricaemia
Blood urea increased
Serum creatinine increased
Hyperglycaemia
Alterations in hepatic enzymes
Rash
Pruritus
Urticaria
Thrombocytopenia
Gynaecomastia
Breast pain
Bone marrow depression
Hearing disturbances
Tinnitus
Deafness
Musculoskeletal pain
Muscle spasm
Hyponatraemia
Hypokalaemia
Hypomagnesaemia
Hypochloraemic alkalosis
Gout
Photosensitivity
Pancreatitis
Myalgia
Circulatory collapse
Leukopenia
Agranulocytosis
Hypocalcaemia
Hyperlipidaemia
Cholestasis
Jaundice
Dermatitis
Acute renal failure
Hypersensitivity reactions
Orthostatic hypotension
Urinary retention
Visual disturbances
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Shelf Life and Storage
Store below 25 degrees C
Store in the original packaging and protect from light
Further Information
Last Full Review Date: April 2011
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia
Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Bumetanide liquid 0.2 mg / ml oral solution. Chemidex Pharma Ltd. Revised February 2010.
Summary of Product Characteristics: Betinex tablets 1mg, Bumetanide 1mg tablets. TEVA UK Ltd. Revised March 2011.
Summary of Product Characteristics: Burinex tablets 1mg. Leo Laboratories Limited. Revised April 2010.
Summary of Product Characteristics: Burinex tablets 5mg. Leo Laboratories Limited. Revised April 2010.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 August 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Bumetanide. Last revised: January 4, 2011.
Last accessed: April 13, 2011.
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