AMILORIDE

Adults:

Amiloride Hydrochloride alone. The usual initial dosage is 10mg (as a single dose or 5mg twice a day). The total daily dose should not exceed 20mg (20ml) a day. After diuresis has been achieved, the dosage may be reduced by 5mg (5ml) increments to the least amount required.

Amiloride Hydrochloride with other diuretic therapy When Amiloride is used with a diuretic which is given on an intermittent basis, it should be given at the same time as the diuretic. 5ml) given once a day together with the usual antihypertensive dosage of the thiazide concurrently employed.

If necessary, increase to 5mg (5ml) given once a day or in divided doses. 5ml) a day together with the usual dose of the diuretic concurrently employed, subsequently adjusted if required, but not exceeding 10mg (10ml) a day. Optimal dosage is determined by the diuretic response and the plasma potassium level.

Once an initial diuresis has been achieved, reduction in dosage may be attempted for maintenance therapy. Maintenance therapy may be on an intermittent basis. Hepatic Cirrhosis with ascites Initiate therapy with a low dose. A single daily dose of 5mg (5ml) plus a low dosage of the other diuretic agent may be increased gradually until there is an effective diuresis.

The dosage of Amiloride Hydrochloride should not exceed 10mg (10ml) a day. Maintenance dosages may be lower than those required to initiate diuresis; dosage reduction should therefore be attempted when the patient’s weight is stabilised.

A gradual weight reduction is especially desirable in cirrhotic patients to reduce the likelihood of untoward reactions associated with diuretic therapy. Children The use of Amiloride Hydrochloride in children under 18 years of age is not recommended as safety and efficacy have not been established.

Elderly The elderly are more susceptible to electrolyte imbalance, and are more likely to experience hyperkalaemia since renal reserve may be reduced. The dosage should be carefully adjusted according to renal function, blood electrolytes and diuretic response.

Amiloride Hydrochloride is normally well tolerated, although minor side effects are reported relatively frequently. Except for hyperkalaemia, significant side effects are infrequent. Nausea, anorexia, abdominal pain, flatulence and mild skin rash are probably due to Amiloride; but other side effects are generally associated with diuresis or with the underlying condition being treated.

Body as a whole Headache, weakness, fatigue, back pain, chest pain, neck/shoulder ache, pain in the extremities. Cardiovascular Angina pectoris, orthostatic hypotension, arrhythmias, palpitation, one patient with partial heart block developed complete heartblock.

Digestive Anorexia, nausea, vomiting, diarrhoea, constipation, abdominal pain, GI bleeding, jaundice, thirst, dyspepsia, flatulence. 5mmol/l, hyponatraemia. Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.

Integumentary Pruritus, rash, dryness of mouth, alopecia. Musculoskeletal Muscle cramps, joint pain. Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated. Nervous Dizziness, vertigo, paraesthesiae, tremors, encephalopathy.

Psychiatric Nervousness, mental confusion, insomnia, decreased libido, depression, somnolence. Respiratory Cough, dyspnoea. Special Senses Nasal congestion, visual disturbances, increased intra-ocular pressure, tinnitus. Urogenital Impotence, polyuria, dysuria, bladder spasm, frequency of micturition.

Reactions in which no causal relationship could be established were activation of probable pre-existing peptic ulcer, aplastic anaemia, neutropenia and abnormal liver function tests. In a few cirrhotic patients, jaundice associated with the underlying disease had deepened but the drug relationship is uncertain.

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 Yellow Card Scheme.

Diabetes Mellitus To minimise the risk of hyperkalaemia in known or suspected diabetic patients, the status of renal function should be determined before initiating therapy. Amiloride Hydrochloride should be discontinued for at least three days before a glucose-tolerance test.

g. patients with cardiopulmonary disease or decompensated diabetes. Shifts in acid-base balance alter the balance of extracellular-intracellular potassium, and the development of acidosis may be associated with rapid increases in plasma potassium.

Hyperkalaemia This has been observed in patients receiving Amiloride Hydrochloride, alone or with other diuretics. These patients should be observed carefully for clinical, laboratory or ECG evidence of hyperkalaemia. Some deaths have been reported in this group of patients.

Hyperkalaemia has been noted particularly in the elderly and in hospital patients with hepatic cirrhosis or cardiac oedema who have known renal involvement, who were seriously ill, or were undergoing vigorous diuretic therapy. Neither potassium-conserving agents nor a diet rich in potassium should be used with Amiloride Hydrochloride except in severe and/or refractory cases of hypokalaemia.

If the combination is used, plasma potassium levels must be continuously monitored. Impaired Renal Function Patients with increases in blood urea over 10mmol/l, serum creatinine over 130μmol/l, or with diabetes mellitus, should not receive Amiloride Hydrochloride without careful, frequent monitoring of serum electrolytes and blood urea levels.

In renal impairment, use of a potassium conserving agent may result in rapid development of hyperkalaemia. Treatment of Hyperkalemia If hyperkalaemia occurs, Amiloride Hydrochloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.

Electrolyte Imbalance and Reversible Blood Urea Increases. Hyponatraemia and hypochloraemia may occur when Amiloride Hydrochloride is used with other diuretics. Reversible increases in blood urea levels have been reported accompanying vigorous diuresis, especially when diuretics were used in seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant oedema.

5mmol/l) other potassium- conserving agents or potassium supplements (see Precautions); Addison’s disease; anuria; acute renal failure, severe progressive renal disease, diabetic nephropathy (see Precautions); prior sensitivity to this product.

Safety for use in children is not established. See also ‘Use in Pregnancy’ and ‘Use in the Breast Feeding mother’.