Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial park, Braithwaite Street, Leeds, LS11 9XE
Potassium – conserving agent; diuretic.
Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics to conserve potassium during periods of vigorous diuresis and during long term maintenance therapy.
In hypertension, it is used as an adjunct to prolonged therapy with thiazides and similar agents to prevent potassium depletion.
In congestive heart failure, Amiloride Hydrochloride may be effective alone, but its principal indication is for concomitant use in patients receiving thiazides or more potent diuretic agents.
In hepatic cirrhosis with ascites, Amiloride Hydrochloride usually provides adequate diuresis, with diminished potassium loss and less risk of metabolic alkalosis, when used alone. It may be used with more potent diuretics when a greater diuresis is required while maintaining a more balanced serum electrolyte pattern.
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.
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.
Usually 2.5mg (2.5ml) 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.
Initially 2.5mg (2.5ml) a day together with the usual dosage of the diuretic concurrently employed, subsequently adjusted if required, but not exceeding 10mg (10ml) a day. Optimal dosage is determined by 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.
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.
The use of Amiloride Hydrochloride in children under 18 years of age is not recommended as safety and efficacy have not been established.
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.
No data are available; and it is not known whether the drug is dialysable.
The most likely signs and symptoms are dehydration and electrolyte imbalance which should be treated by established methods. Therapy should be discontinued and the patient observed closely. No specific antidote is available. If ingestion is recent, emesis should be induced or gastric lavage performed. Treatment is symptomatic and supportive. If hyperkalaemia occurs, active measures should be taken to reduce plasma potassium levels.
The plasma half life of amiloride is about six hours.
Shelf life in marketed pack 12 months.
Store at or below 25 °C, out of reach of children.
Glass (Type III) amber bottle, with capacity of 150ml.
Closures: HDPE EPE wadded, tamper evident, child resistant.
None stated.
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