AMILORIDE

Adults:

Initially 10mg daily or 5mg twice daily, adjusted according to response. The dosage may be increased up to a maximum of 20mg daily. Used as an adjunct to other diuretics for hypertension and congestive heart failure: Initially 5mg or 10mg daily.

Cirrhosis with ascites:

Initially 5mg daily.

Elderly:

The dosage should be adjusted according to renal function, blood electrolytes and diuretic response.

Children under 18 years:

Not indicated.

Amiloride is usually well tolerated. Except for hyperkalaemia significant side effects are infrequent.

Reported side-effects include the following:

Blood and lymphatic system disorders: Aplastic anaemia and neutropenia have been reported rarely.

Psychiatric disorders:

Decreased libido, somnolence, mental confusion, or minor psychiatric changes may occur.

Nervous system disorders:

Encephalopathy, paraesthesia.

Eye disorders:

Visual changes.

Cardiac disorders:

Angina pectoris, arrhythmias, palpitations, postural hypotension, dizziness.

Respiratory, thoracic and mediastinal disorders:

Dyspnoea, cough.

Gastrointestinal disorders:

Nausea, vomiting, constipation or diarrhoea, abdominal pain.

Hepatobiliary disorders:

Abnormal liver function. A deepening of jaundice has occurred in cirrhotic patients receiving amiloride hydrochloride alone, but the relationship to amiloride is uncertain.

Skin and subcutaneous tissue disorders:

Alopecia, rash, pruritus. g. hyperkalaemia (particularly in elderly patients, diabetics and patients with renal impairment) and hyponatraemia occasionally occur. Signs include dry mouth, thirst, headache, muscle cramps and weakness. Rises in blood-urea-nitrogen concentrations may occur with amiloride.

Amiloride should be given with caution to elderly patients, patients likely to develop acidosis, patients with diabetes mellitus and those with impaired hepatic or renal function. Patients with impaired renal function should be monitored carefully for serum electrolytes and blood urea levels, as should seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis or those with resistant oedema who are also taking diuretics.

Patients taking amiloride either alone or with other diuretics or angiotensin-converting enzyme inhibitors may develop hyperkalaemia. Serum electrolytes and blood urea should be monitored periodically. If hyperkalaemia occurs, amiloride hydrochloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.

Amiloride should be discontinued at least three days before a glucose tolerance test because of the risk of provoking severe hyperkalaemia. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

Hyperkalaemia, severe renal impairment, prior sensitivity to amiloride. Other potassium-sparing drugs and potassium supplements are contraindicated during amiloride therapy. The safety of amiloride hydrochloride for use in children under 18 years of age has not been established.