AMORIDE

Posology:

Adults: The initial dosage should be 10 mg either as a single dose or 5 mg twice a day. This may be increased if necessary, but must not exceed 20 mg (4 tablets) per day. After diuresis has been achieved, the dosage may be reduced to the least amount required (by 5 mg increments).

5 mg (½ tablet) a day, together with the usual dosage of other diuretic agents. If diuresis is not achieved with minimal dosage of both agents, the dosage of both may be gradually increased, but that of Amiloride should not exceed 10 mg (2 tablets) a day.

Once diuresis has been achieved, reduction in dosage of both agents may be attempted for maintenance therapy. The dosage of both agents should be determined by the diuretic response and the plasma potassium level. 5 mg to 10 mg (½ to 2 tablets) a day, together with the usual antihypertensive dosage of thiazides.

e. 5 mg (1 tablet), plus a low dosage of the other diuretic agent. If necessary, dosage of both agents may be increased gradually until there is effective diuresis. The dosage of Amiloride should not exceed 10 mg (2 tablets) a day. Maintenance doses may be lower than those required to initiate diuresis; reduction in the daily dosage should therefore be attempted when the patient's weight is stabilised.

Gradual weight reduction in cirrhotic patients is especially desirable to reduce the likelihood of untoward reactions.

Older People:

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

Paediatric Population:

The use of Amiloride is not recommended in children.

Method of Administration:

Oral

5 mmo1/l), hyponatraemia (when used with other diuretics), metabolic acidosis Psychiatric disorders: Nervousness, agitation, mental confusion, insomnia, somnolence, decreased libido, depression, minor psychiatric changes Nervous system disorders: Headache, dizziness, paraesthesia, tremor, encephalopathy Eye disorders: Minor visual disturbances, increased intra-ocular pressure Ear and labyrinth disorders: Tinnitus, vertigo Cardiac disorders: Angina pectoris, arrhythmias, palpitation One patient with a partial heart block developed complete heart block.

Vascular disorders:

Orthostatic hypotension Respiratory, thoracic and mediastinal disorders: Cough, nasal congestion, dyspnoea Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, abdominal pain, thirst, dyspepsia, heartburn, flatulence, dry mouth, GI bleeding, (*activation of likely pre-existing peptic ulcer) Hepatobiliary disorders: Jaundice (*abnormal liver function tests) Skin and sub-cutaneous disorders: Mild Skin rashes, pruritus, alopecia Musculoskeletal and connective tissue disorders: Muscle cramps, joint pain, back pain, chest pain, neck/shoulder ache, pain in extremities Renal and urinary disorders: Urinary disturbances: polyuria, dysuria, bladder spasms, urinary frequency Reproductive system and breast disorders: Sexual dysfunction, impotence General disorders and administration site conditions: Weakness, fatigue, malaise *Unknown causal relationship 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. uk/yellowcard].

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 should be discontinued at least three days before a glucose tolerance test because of the risks of provoking severe hyperkalaemia.

g. patients with cardiopulmonary disease of 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, alone or with other diuretics. These patients should be observed carefully for clinical, laboratory and 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 except in severe and/or refractory cases of hypokalaemia.

3). 5).

Impaired renal function:

Patients with increases in blood urea over 10 mmol/l, serum creatinine over 130 umol/l, or with diabetes mellitus, should not receive Amiloride without careful frequent monitoring of serum electrolytes and blood urea levels. 3).

Electrolyte imbalance and blood urea increases:

Hyponatraemia and hypochloraemia may occur when Amiloride 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.

Careful monitoring of serum electrolytes and blood urea levels should therefore be carried out when Amiloride is given with oral diuretics to such patients. 2). Hepatic encephalopathy has been reported in patients with pre-existing severe liver disease.

Excipient warnings:

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorbtion should not take this medicine.

3. 4) Addison’s disease