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FRUMIL (AMILORIDE, FUROSEMIDE): PRECAUTIONS

Urinary outflow must be secured. In patients with a partial obstruction of urinary outflow (eg. patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra), increased production of urine may provoke or aggravate complaints. Thus, these patients require careful monitoring especially during the initial stages of treatment.

Treatment with Amiloride HCl amd Furosemide (Frumil) necessitates regular medical supervision. Particularly careful monitoring is required in patients with: hypotension, in patients who would be at particular risk from a pronounced fall in blood pressure (eg. significant stenoses of the coronary arteries or of the blood vessels supplying the brain), latent or manifest diabetes mellitus, gout, hepatorenal syndrome (i.e. functional renal failure associated with severe liver disease), hypoproteinaemia (eg. associated with nephrotic syndrome).

All potassium conserving diuretic combinations can cause an abnormal elevation of serum potassium. It is recommended that measurements of potassium are made at appropriate intervals and at time of dosage adjustment, particularly in elderly or diabetic patients and also in patients with confirmed or suspected renal impairment and a creatinine clearance below 60 mL/min per 1.73 m2 body surface area as well as in cases where Amiloride Hydrochloride, Furosemide (Frumil) is taken in combination with certain other drugs which may lead to an increase in potassium concentration. Warning signs of hyperkalemia include parasthesia, muscular weakness, fatigue, flaccid paralysis extremities, bradycardia, shock, serum potassium and ECG abnormalities. Should hyperkalemia occur, Frumil should be discontinued and measures to reduce plasma potassium may be necessary.

Regular monitoring of serum sodium, potassium and creatinine and blood glucose is generally recommended during Frumil therapy; particularly close monitoring is required in patients at high risk of developing electrolyte imbalances or in case of significant additional fluid loss (e.g. due to vomiting, diarrhoea or intense sweating).

Hyponatraemia, hypochloraemia and raised blood urea nitrogen may occur during vigorous diuresis, especially in seriously ill patients. Careful monitoring of serum electrolytes and urea should, therefore, be undertaken in these patients.

Hypovolaemia or dehydration as well as any significant electrolyte and acid-base disturbances must be corrected. This may require temporary discontinuation of Frumil.

The dosage of concurrently administered cardiac glycosides or antihypertensive agents may require adjustment.

Frumil (Amiloride, Furosemide) should be discontinued before a glucose tolerance test.

Caution should be exercised and the risks and benefits of combining risperidone with furosemide (frusemide) or other potent diuretics should be considered prior to the decision to treat. In the risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide (frusemide) plus risperidone (7.3%; mean age 89 years, range 75 to 97) compared to treatment with risperidone alone (3.1%; mean age 84 years, range 70 to 96) or furosemide alone (4.1%; mean age 80 years, range 67 to 90). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low doses) was not associated with similar mortality findings. No pathophysiological mechanism has been identified to explain this finding and no consistent pattern for cause of death was observed.

Nevertheless, caution is advised. Irrespective of treatment, dehydration was an overall risk factor for mortality and should, therefore, be carefully avoided in elderly patients with dementia.

Use in Pregnancy

Frumil (Amiloride HCl, Furosemide) must not be taken during pregnancy.

Use in Lactation

The safety of Frumil (Amiloride Hydrochloride, Furosemide) in lactation has not been established; however, furosemide passes into breast milk and may partially inhibit lactation. The use of this medication in lactating mothers should be avoided.

Use in Children

No experience is available regarding the use of Amiloride with Furosemide (Frumil) in children.

Effects on Ability to Drive and Use Machines

Some adverse effects (eg. a pronounced fall in blood pressure) may impair the patient's ability to concentrate and react, and therefore, constitute a risk in situations where these abilities are of special importance eg. operating a vehicle or machinery.



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