- amiloride hydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
Excipient(s) with known effect:
Liquid maltitol (E965) 3415mg/5ml
Methyl hydroxybenzoate (E218) 6mg/5ml
Propyl hydroxybenzoate (E216) 1.5mg/5ml
Propylene glycol (E1520) 103.5mg/5ml
For excipients see section 6.1
Amiloride Hydrochloride with other diuretic therapyWhen Amiloride is used with a diuretic which is given on an intermittent basis, it should be given at the same time as the diuretic.
HypertensionUsually 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.
Congestive heart failureInitially 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.
Hepatic Cirrhosis with ascitesInitiate 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.
ChildrenThe use of Amiloride Hydrochloride in children under 18 years of age is not recommended as safety and efficacy have not been established.
ElderlyThe 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.
Diabetes MellitusTo 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.
Metabolic or Respiratory AcidosisPotassium-conserving therapy should be initiated only with caution in severely ill patients in whom metabolic or respiratory acidosis may occur e.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.
HyperkalaemiaThis has been observed in patients receiving Amiloride Hydrochloride, alone or with other diuretics. These patients should be observed carefully for clinical, laboratory or 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 Hydrochloride except in severe and/or refractory cases of hypokalaemia. If the combination is used, plasma potassium levels must be continuously monitored.
Impaired Renal FunctionPatients with increases in blood urea over 10mmol/l, serum creatinine over 130µmol/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 HyperkalemiaIf hyperkalaemia occurs, Amiloride Hydrochloride should be discontinued immediately and, if necessary, active measures taken to reduce the plasma potassium level.
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 Hydrochloride is given with other diuretics to such patients.
Cirrhotic patientsOral 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 and coma, and increased jaundice has been reported in association with diuretics, including Amiloride Hydrochloride.
This product contains:
- Liquid maltitol (E965). Patients with rare hereditary problems of fructose should not take this medicine.
- Methyl and propyl hydroxybenzoates are contained in this product which may cause allergic reactions (possibly delayed).
- Propylene glycol (E1520) 103.5mg in each 5ml. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
- Ethanol. This medicine contains 3.7 mg of alcohol (ethanol) in each 5 ml. The amount in 5 ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Body as a wholeHeadache, weakness, fatigue, back pain, chest pain, neck/shoulder ache, pain in the extremities.
CardiovascularAngina pectoris, orthostatic hypotension, arrhythmias, palpitation, one patient with partial heart block developed complete heartblock.
DigestiveAnorexia, nausea, vomiting, diarrhoea, constipation, abdominal pain, GI bleeding, jaundice, thirst, dyspepsia, flatulence.
Metabolism and nutrition disordersElevated plasma potassium levels above 5.5mmol/l, hyponatraemia. Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.
IntegumentaryPruritus, rash, dryness of mouth, alopecia.
MusculoskeletalMuscle cramps, joint pain. Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.
NervousDizziness, vertigo, paraesthesiae, tremors, encephalopathy.
PsychiatricNervousness, mental confusion, insomnia, decreased libido, depression, somnolence.
Special SensesNasal congestion, visual disturbances, increased intra-ocular pressure, tinnitus.
UrogenitalImpotence, polyuria, dysuria, bladder spasm, frequency of micturition.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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. www.mhra.gov.uk/yellowcard
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879