AMILORIDE HYDROCHLORIDE is a brand name for Amiloride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: While Amiloride may be used independently, its main indication is for concurrent therapy with either thiazide diuretics such as hydrochlorothiazide or loop diuretics such as furosemide in order to conserve potassium in those at risk from hypokalaemia during episodes of vigorous diuresis and during long-term…
Verbatim from this product's MHRA label. Tap a section to expand.
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 in children under 18 years of age is not recommended as safety and efficacy have not been established.
Method of Administration:
Oral
Amiloride is usually well tolerated, although minor side-effects are reported relatively frequently. Apart from hyperkalaemia, significant adverse reactions have been infrequently reported. 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 disease being treated.
Blood and lymphatic system disorders:
Rise in blood urea-nitrogen concentrations, (*aplastic anaemia, *neutropenia). 5 mmo1/l), hyponatraemia (when used with other diuretics), metabolic acidosis, Serum uric acid levels may rise during treatment with amiloride and acute attacks of gout may be precipitated Psychiatric disorders: Nervousness, agitation, mental confusion, insomnia, decreased libido, somnolence, depression, minor psychiatric changes Nervous system disorders: Headache, dizziness, paraesthesia, tremor, encephalopathy, somnolence 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).
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 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, 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). If hyperkalaemia occurs, Amiloride hydrochloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.
Impaired renal function:
Patients with increases in blood urea over 10 mmol/l, serum creatinine over 130 μmol/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:
1. 4). Anuria. 4). Addison’s disease. Safety for use in children is not established
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Amiloride in United Kingdom.
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Skin and subcutaneous tissue 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.
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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, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.