CO-AMILOZIDE

Posology The rate of loss of weight and the serum electrolyte levels should determine the dosage. 0 kg/day. Adults Hypertension Initially one tablet given once a day. The dosage may be increased if necessary to two tablets given once a day or in divided dose.

Co-amilozide may be used alone or as an adjunct to other antihypertensive drugs, but since the antihypertensive effect of these agents may be enhanced, their dosage may need to be reduced in order to reduce the risk of an excessive drop in pressure.

Congestive heart failure Initially one tablet a day, subsequently adjusted if required, but not exceeding four tablets a day. Optimal dosage is determined by the diuretic response and the plasma potassium level. Once 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 dose of two tablets may be increased gradually until there is an effective diuresis. Dosage should not exceed four tablets a day.

A gradual weight reduction is especially desirable in cirrhotic patients to reduce the likelihood of untoward reactions associated with diuretic therapy. Maintenance dosages may be lower than those required to initiate diuresis; dosage reduction should therefore be attempted when the patient’s weight is stabilised.

Paediatric population Co-amilozide is not recommended for children under 18 years of age as safety and efficacy has not been established. Elderly Particular caution is needed in the elderly because of their susceptibility to electrolyte imbalance.

4). Method of administration For oral use.

Although minor side effects are relatively common, serious side effects are infrequent. Reported side effects are generally associated with diuresis, thiazide therapy, or with the underlying disease. No increase in the risk of adverse reactions has been seen over those of the individual components.

4) and symptomatic hyponatraemia. Hyponatraemia as a complication is rare but constitutes a medical emergency as onset may be rapid. The symptoms of hyponatraemia may be non-specific and include nausea, lethargy, weakness, irritability, mental confusion, muscle cramps and anorexia, but it may be an important cause of morbidity.

Severe sequelae of hyponatraemia include tonic- clonic seizures and clinical features resembling subarachnoid haemorrhage.

Psychiatric disorders:

Insomnia, nervousness, mental confusion, depression Nervous system disorders: Headache, dizziness, sleepiness, syncope, paraesthesia, stupor, bad taste Eye disorders: Visual disturbances Ear disorders: Vertigo Cardiac disorders: Arrhythmias, tachycardia, angina pectoris Vascular disorders: Orthostatic hypotension, flushing Respiratory, thoracic and mediastinal disorders: Dyspnoea, hiccups, nasal congestion.

Gastrointestinal disorders:

Nausea, vomiting, diarrhoea, constipation, abdominal pain, gastrointestinal bleeding, abdominal fullness, flatulence Skin and subcutaneous tissue disorders: Rash, pruritus, diaphoresis Musculoskeletal and connective tissue disorders: Leg ache, muscle cramps, joint pain, back pain Renal and urinary disorders: Nocturia, renal dysfunction including renal failure, dysuria, incontinence Reproductive system and breast disorders: Impotence occurring early in the course of treatment (onset after 2 years unlikely) and reversible on withdrawal of treatment.

Hyperkalaemia:

Hyperkalaemia has been observed in patients receiving amiloride hydrochloride, either alone or with other diuretics, particularly in the elderly and in diabetics. Hyperkalaemia has been reported in seriously ill hospital patients with congestive heart failure or hepatic cirrhosis who had renal impairment, or were undergoing vigorous diuretic therapy.

Such patients should be carefully observed for laboratory, clinical and ECG evidence of hyperkalaemia (which may not always be associated with an abnormal ECG). Some deaths have been reported in this group of patients.

Treatment of hyperkalaemia:

Should hyperkalaemia develop, co-amilozide should be discontinued immediately. If necessary, active measures should be taken to reduce the serum potassium to normal.

Impaired renal function:

Due to the risk of developing hyperkalaemia, 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.

Thiazide diuretics become ineffective when creatinine clearance falls below 30 ml/min.

Electrolyte imbalance and blood urea increases:

Although the likelihood of electrolyte imbalance is reduced by co-amilozide, careful check should be kept for such signs of fluid and electrolyte imbalance, hyponatraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaemia, particularly in the elderly and in patients receiving long-term therapy and in the presence of excessive vomiting or during parenteral fluid therapy.

5mmol/l); other potassium-conserving diuretics. Potassium supplements or potassium-rich foods (except in severe and/or refractory cases of hypokalaemia under careful monitoring) • Hypercalcaemia • Severe renal impairment; severe progressive renal disease; acute renal failure; anuria; use of potassium conserving agents may result in rapid development of hyperkalaemia in patients with renal impairment; patients with blood urea over 10 mmol/l or those with serum creatinine over 130 μmol/l in whom serum electrolyte and blood urea levels cannot be monitored carefully and frequently • Severe hepatic failure; precoma associated with hepatic cirrhosis • Diabetic nephropathy; patients with diabetes mellitus • Addison’s disease • Concomitant treatment with spironolactone or triamterene • Concurrent lithium therapy Co-amilozide is not recommended for use in children under 18 years old.