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BUMETANIDE 0.2 MG/ML ORAL SOLUTION

Active substance(s): BUMETANIDE / BUMETANIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Bumetanide 0.2 mg/ml Oral Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.2 mg bumetanide.

3

PHARMACEUTICAL FORM
Oral solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Bumetanide is indicated whenever diuretic therapy is required in the treatment
of oedema, e.g. that associated with congestive heart failure, cirrhosis of the
liver and renal disease including the nephrotic syndrome.

4.2

Posology and method of administration
For oral administration.
Adults:

Usually 1 mg (5 ml) as a single oral dose given morning or
early evening.The dosage should be adjusted according to the
patient's response.

4.3

Children:

Not recommended for children under 12 years of age.

Elderly:

Adjust dosage according to response: a dose of 0.5 mg
bumetanide per day may be sufficient in some elderly
patients.

Contraindications
Although bumetanide can be used to induce diuresis in renal insufficiency, any
marked increase in blood urea or the development of oliguria or anuria during
treatment of severe progressing renal disease are indications for stopping
treatment with bumetanide.
Hypersensitivity to any of the ingredients. Bumetanide is contra-indicated in
hepatic coma and care should be taken in states of severe electrolyte depletion.
As with other diuretics, bumetanide should not be administered concurrently
with lithium salts. Diuretics can reduce lithium clearance resulting in high
serum levels of lithium.

4.4

Special warnings and precautions for use
Excessively rapid mobilisation of oedema particularly in elderly patients may
give rise to sudden changes in cardiovascular pressure flow relationships with
circulatory collapse. This should be borne in mind when bumetanide is given
in high doses. Electrolyte disturbances may occur, particularly in those
patients taking a low salt diet. Regular checks of serum electrolytes, in
particular sodium, potassium, chloride and bicarbonate should be performed
and replacement therapy instituted where indicated.
As with other diuretics, bumetanide may cause an increase in blood uric acid.
Periodic checks on urine and blood glucose should be made in diabetics and
patients suspected of latent diabetes (see section 4.5).
Patients with chronic renal failure on high doses of bumetanide should remain
under constant hospital supervision.
Caution is advised when used in patients with hypotension and in patients with
porphyria.

Caution should be exercised when used in patients with hepatic impairment as
there may be increased risk of encephalopathy.
Bumetanide should be used with caution in patients already receiving
nephrotoxic or ototoxic drugs.
In patients with known hypersensitivity to sulfonamides or thiazides there may
be a potential risk of hypersensitivity to bumetanide.
Bumetanide found in urine by doping test is cause for disqualification of
athletes.

4.5

Interaction with other medicinal products and other forms of interaction
Like other diuretics, bumetanide shows a tendency to increase the excretion of
potassium which can lead to an increase in the sensitivity of the myocardium
to the toxic effects of digitalis. Thus the dose may need adjustment when
given in conjunction with cardiac glycosides.
Bumetanide may potentiate the effects of antihypertensive drugs. Therefore,
the dose of the latter may need adjustment when bumetanide is used to treat
oedema in hypertensive patients.
Certain non-steroidal anti-inflammatory drugs have been shown to antagonise the
action of diuretics.

4.6

Pregnancy and lactation
Pregnancy: There are no adequate data from the use of Bumetanide in
pregnant women. Bumetanide should not be used during pregnancy unless
clearly necessary. It may be used only when the potential benefit justifies the
potential risk to the foetus.
Lactation: There is insufficient information on the excretion of Bumetanide in
human or animal breast milk. Therefore Bumetanide should not be taken by
nursing mothers.

4.7

Effects on ability to drive and use machines

Patients who experience dizziness or fatigue should not drive or operate
machinery.

4.8

Undesirable effects
The following side effects, listed below by system organ class, have been reported
to be associated with bumetanide use. Since only post marketing data are
available, the frequency for these side effects is unknown.
Blood and lymphatic system disorders
Thrombocytopenia, leukopenia, bone marrow failure, agranulocytosis
Immune system disorders
Hypersensitivity
Metabolism and nutrition disorders
Electrolyte imbalance, for example:
Hypokalaemia, hyponatraemia, dehydration, hypomagnesaemia, gout,
hyperuricaemia, alkalosis hypochloraemic, hyperglycaemia, hypocalcaemia,
hyperlipidaemia
Nervous system disorders
Headache, dizziness
Ear and labyrinth disorders
Tinnitus, deafness
Vascular disorders
Orthostatic hypotension, hypotension
Gastrointestinal disorders
Gastrointestinal disorder, for example:
Nausea, vomiting, diarrhoea, abdominal pain
Hepatobiliary system disorders
Cholestasis, jaundice
Skin and subcutaneous tissue disorders
Rash*, urticaria, dermatitis, photosensitivity reaction, pruritus
*Various types of rash reactions such as erythematous, maculo-papular and
pustular have been reported.
Musculoskeletal, connective tissue and bone disorders
Myalgia, muscle spasm, arthralgia

Renal and urinary disorders
Renal failure acute
Reproductive system and breast disorders
Gynaecomastia, breast pain
General disorders and administrative site conditions
Fatigue
Investigations
Blood creatinine increased
High 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. 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 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 professionals are asked to report any suspected
adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms would be those caused by excessive diuresis. Empty stomach by
gastric lavage or emesis. General measures should be taken to restore blood
volume, maintain blood pressure and correct electrolyte disturbance.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Bumetanide is a potent, high ceiling diuretic with a rapid onset and a short duration of
action.

5.2

Pharmacokinetic properties
After oral administration of 1 mg 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 1 mg dose.
In most patients 1 mg of bumetanide produces a similar diuretic effect to 40
mg of furosemide.
Bumetanide is well absorbed after oral administration. Bumetanide excretion
in the urine shows a good correlation with the diuretic response. In patients
with chronic renal failure, the liver takes more importance as an excretory
pathway, although the duration of action in such patients is not markedly
prolonged.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that already included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, xanthan
gum, sodium citrate, patent blue V, quinoline yellow, peppermint flavour,
purified water.

6.2

Incompatibilities
None known.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Amber glass bottles, with plastic screw caps, of 5, 10, 25 and 150 ml.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
CHEMIDEX PHARMA LTD
T/A ESSENTIAL GENERICS
7 EGHAM BUSINESS VILLAGE
CRABTREE ROAD
EGHAM

SURREY, TW20 8RB
UNITED KINGDOM

8

MARKETING AUTHORISATION NUMBER(S)
PL 17736/0132

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/05/2012

10

DATE OF REVISION OF THE TEXT
20/04/2016

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Source: Medicines and Healthcare Products Regulatory Agency

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