Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Urinary output must be secured. Patients with partial obstruction of urinary outflow, for example patients with prostatic hypertrophy or impairment of micturition have an increased risk of developing acute retention and require careful monitoring.

Steps should be taken to correct hypovolaemia before commencing therapy in oliguria.
Caution is required in patients with liver failure, porphyria, pancreatitis or a history of pancreatitis, systemic lupus erythematosus or a history of systemic lupus erythematosus or severe asthma (hypokalaemia associated with beta2-agonist therapy can be potentiated by the concurrent use of diuretics). The insulin requirements of diabetic patients may increase on treatment with furosemide and latent diabetes may become manifest.

Particularly careful monitoring is necessary in:
• patients with hypotension – correct before use
• patients who are at risk from a pronounced fall in blood pressure
• patients with gout
• patients with hepatorenal syndrome
• patients with hypoproteinaemia, e.g. associated with nephrotic syndrome (the effect of furosemide may be weakened and its ototoxicity potentiated).
Cautious dose titration is required.
• premature infants and neonates (possible development of nephrocalcinosis /nephrolithiasis in association with increased calcium excretion during long-term furosemide treatment; renal function must be monitored and renal ultrasonography performed)

Caution should be observed in patients liable to electrolyte deficiency such as the elderly. The risk of hypokalaemia is increased in patients with severe or congestive heart failure, hepatic cirrhosis or hyperaldosteronism. Regular monitoring of serum sodium, potassium and creatinine is generally recommended during furosemide therapy; particularly close monitoring is required in patients at 
high risk of developing electrolyte imbalances or in case of significant additional fluid loss.
Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of furosemide. Possibility of hypocalcaemic tetany in hypoparathyroid patients.

Prolonged treatment with furosemide can lead to thiamine deficiency, particularly in congestive heart failure or the elderly.

This medicinal product contains 7.7 mg of sodium in a 2ml ampoule. To be taken into consideration by patients on a controlled sodium diet.

In patients who are at high risk for radiocontrast nephropathy, furosemide is not recommended to be used for dieresis as part of the preventative measures against radiocontrast-induced nephropathy.

Concomitant use with risperidone:
In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97 years) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96 years) or furosemide alone (4.1%; mean age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.

No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be avoided in elderly patients with dementia.

Effects on Driving

4.7 Effects on ability to drive and use machines

Reduced mental alertness may impair ability to drive or operate dangerous machinery.