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Logo BURINEX® K

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form)

BURINEX® K
Tablets

COMPOSITION:
Each tablet contains:

Bumetanide 0,5 mg and Potassium Chloride 573 mg (in a slow release wax core).

PHARMACOLOGICAL CLASSIFICATION:
A 18.1 Diuretics

PHARMACOLOGICAL ACTION:
BURINEX®K
combines the very high potent high-ceiling diuretic bumetanide, with a slow release potassium chloride supplement. Bumetanide has a rapid onset and a short duration of action. As with most diuretics, long-term therapy may be associated with potassium depletion.
In-vitro studies suggest that the potassium supplement in BURINEX®K may help to maintain normal levels of potassium, especially in those patients whose dietary intake of potassium is inadequate.
The formulation of BURINEX®K presents the following advantages. The diuretic is coated round the tablet, from which it is rapidly released. The diuretic and saliuretic effect begins within 30 minutes after oral administration, peaks at 1-2 hours and is largely complete within 3 hours.
In-vitro studies suggest that, in contrast, the potassium chloride which is included in an inert wax core, is released only slowly over a period of 6 hours after oral ingestion. This slow release minimises the risk of gastro-intestinal intolerance as well as that of ulceration and stenosis resulting from localised high concentrations of potassium salts in the small bowel. (For further pharmacological and clinical data on BURINEX®itself, see BURINEX®Data Sheet).
This medicine contains potassium chloride. It has not been proven that this dosage will necessarily prevent a significant potassium loss or correct an existing deficiency of potassium.

INDICATIONS:
BURINEX®K
is indicated for the treatment of all forms of oedema, particularly where supplementary potassium chloride is desirable. Low serum potassium levels are, for example, known to increase the toxic effects of the cardiac glycosides; BURINEX®K may therefore be of particular value in those patients being treated with digitalis.

CONTRA-INDICATIONS:
Anuria. Although plain BURINEX®may, with appropriate precautions, be used to induce diuresis in renal insufficiency, BURINEX® K is not recommended for this indication. BURINEX®K is contra-indicated in hepatic coma and in acute cases of moderately severe or severe liver failure. This does not preclude its use in the treatment of ascites due to hepatic cirrhosis but such therapy is best initiated in hospital.
Hyperkalaemia with BURINEX® K is only likely to occur in those patients with renal insufficiency or if potassium-sparing diuretics are also used (eg. spironolactone, triamterene or amiloride). The use of potassium-sparing diuretics with BURINEX® K is contra-indicated.

WARNINGS:
BURINEX® K Tablets must be swallowed whole and never chewed.

DOSAGE AND DIRECTIONS FOR USE:
For initial therapy, most patients will be treated with the diuretic alone. The dose required will be adjusted according to the patient's response but is likely to vary between 0,5 and 2,0 mg. For maintenance therapy BURINEX® Kis more convenient than diuretic alone. In many patients, 2 tablets as a single dose (1,0 mg BURINEX®and 15,4 mEq potassium) should prove adequate.
For some patients, however, this maintenance dose may be inadequate. Larger doses should preferably be given in divided doses. If a daily dosage of more than four tablets of BURINEX®K is required, then the diuretic itself should be substituted and potassium chloride given separately as a slow-release preparation.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The potassium chloride included in the usual dose may be sufficient to prevent hypokalaemia in some patients; this amount may be inadequate in others, especially in patients with ascites.
Periodic checks should therefore be made on the serum potassium level in patients on long-term therapy.
The diuretic in BURINEX® Kmay potentiate the effect of anti-hypertensive drugs, increase blood uric acid and (though rarely) affect carbohydrate metabolism (see BURINEX®Data Sheet).
Non-specific small bowel lesions characterised by stenosis and possibly accompanied by ulceration have been associated with the oral administration of tablets and capsules containing potassium salts. Symptoms and signs which indicate ulceration or obstruction of the small bowel in patients taking tablets or capsules containing potassium salts are indications for stopping treatment with such preparations immediately.
Pregnancy:
Although tests in four animal species have shown no teratogenic effects, the ordinary precaution of avoiding the use of BURINEX® K in the first trimester of pregnancy should at present be observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Generally, measures should be taken to restore blood volume, maintain blood pressure and correct electrolyte disturbance. No other specific treatment appears to be necessary.

IDENTIFICATION:
A white, ovoid, unmarked, sugar-coated tablet.

PRESENTATION:
Packs of 100, 250 and 500 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER:
J/18.1/36

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
Bryanston 2021

Under licence from:
Leo Pharmaceutical Products, Denmark

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1978

® - Registered Trademark

020971-01
New addition to this site: April 2004
Current March 2006
Source: Community Pharmacy

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