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AMILORIDE is a brand name for Amiloride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Potassium- conserving agent;diuretic. Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics in order to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy. In congestive heart failure,…
Verbatim from this product's MHRA label. Tap a section to expand.
The initial dosage is 10 mg (as a single dose or 5mg twice a day). The total daily dose should not exceed 20mg (4 tablets) per day. After diuresis has been achieved, the dosage may be reduced by 5mg 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. 5mg) given once a day together with the usual antihypertensive dosage of the thiazide concurrently employed.
If necessary, increase to 5mg (one ‘Amiloride’ tablet) given once a day or in divided doses. 5mg) a day together with the usual dosage of the diuretic concurrently employed, subsequently adjusted if required, but not exceeding two ‘Amiloride’ tablets (10mg) 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.
e. 5mg (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 two ‘Amiloride’ tablets (10 mg) a day.
Maintenance dosages 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 associated with diuretic therapy.
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.
Children:
The use of Amiloride in children under 18 years of age is not recommended as safety and efficacy have not been established.
The following adverse reactions may occur during the use of Amiloride. The side effects are listed below by system/organ class and frequency.
Frequencies are defined as follows:
Very common (≥1/10 patients) Common (≥1/100, <1/10 patients) Uncommon (≥1/1,000, <1/100 patients) Rare (≥1/10,000, <1/1,000 patients) Very rarely (<1/10,000 patients) Not known (cannot be determined with available data). 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 rashes have been reported and are probably related to Amiloride: but other side effects are generally associated with diuresis, or with the underlying disease being treated.
Blood and lymphatic system disorders Not known:
Aplastic anaemia, neutropenia.
Nervous system disorders Not known:
Tremors, encephalopathy.
Eye disorders Not known:
Increased eye pressure.
Balance organ and ear disorders Not known:
Tinnitus.
Cardiac disorders1 Not known:
Palpitations.
Respiratory, thoracic and mediastinal disorders Not known:
Coughing.
Gastrointestinal disorders Not known:
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.
In diabetic patients, insulin requirements may change; latent diabetes may become manifest during treatment. 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 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, If the combination is used, plasma potassium levels must be continuously monitored.
Impaired renal function:
Patients with increases in blood urea over 10 mmol/l, serum creatinine over 150 μmol/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 Hyperkalaemia If hyperkalaemia occurs, Amiloride hydrochloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.
1. 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’.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Activation of probably pre-existing peptic ulcer, dyspepsia, dry mouth.
Liver and bile disorders Not known:
Hepatic function abnormalities, jaundice.
Skin and subcutaneous tissue disorders Not known:
Hair loss Kidney and urinary tract disorders Not known: Polyuria, pollakiuria, bladder spasms.
Reproductive system and breast disorders Not known:
Decreased libido.
General disorders and administration site disorders Not known:
Pain in neck and shoulder, pain in extremities.
Description of selected side effects 1 Cardiac disorders:
One patient with partial heart block suffered total heart block. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Careful monitoring of serum electrolytes and blood urea levels should therefore be carried out when Amiloride is given with other diuretics to such patients.
Cirrhotic patients:
Oral diuretic therapy is more frequently accompanied by side effects in patients with hepatic cirrhosis with or without ascites, because these patients are intolerant of acute shifts in electrolyte balance, and because they often already have hypokalaemia as a result of associated aldosteronism.
In patients with pre-existing severe liver disease, hepatic encephalopathy manifested by tremors, confusion, coma and increased jaundice, has been reported in association with diuretics, including Amiloride hydrochloride.
Paediatric patients:
It has not been established that amiloride can be safely used in children. Its use in children should therefore be discouraged.
Excipients Lactose:
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium:
This medicine contains less than 1 mmol (23mg) sodium per tablet, that is to say essentially ‘sodium-free’.