This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Amiloride hydrochloride oral


Oral formulations containing amiloride hydrochloride

Drugs List

  • amiloride 5mg tablets
  • amiloride 5mg/5ml solution sugar-free
  • Therapeutic Indications


    Ascites and oedema associated with hepatic cirrhosis
    Congestive heart failure
    Potassium conservation when given with thiazide or loop diuretic



    Initial dose: 10mg a day (as a single or divided dose).
    Dose may be increased to a maximum of 20mg daily.
    Once diuresis is achieved, reduce dose in increments of 5mg to the least amount required.

    Combined therapy
    When amiloride is administered with a diuretic which is given intermittently, the amiloride dose should be given at the same time. Low doses are usually initiated and increased accordingly to achieve the desired result. Once result has been achieved and patient is stabilised, doses may be reduced.

    Congestive heart failure
    Initial dose: 2.5mg to 10mg once daily.
    Where this is not adequate, the dose of both amiloride and the concurrent agent may be increased, up to a maximum of 20mg amiloride daily.

    Initial dose: 2.5mg to 10mg once daily.
    It is not usually necessary to exceed 10mg of amiloride, but the maximum should not exceed 20mg daily.

    Hepatic cirrhosis with ascites
    Initiate with a low dose of 5mg once daily.


    Oedema in heart failure or hepatic disease where potassium conservation required (unlicensed)

    Children aged 12 to 18 years
    5mg to 10mg twice daily.
    Children aged 1 month to 12 years
    100 to 200micrograms/kg twice daily (up to a maximum daily dose of 20mg).


    Oedema in heart failure or hepatic disease where potassium conservation required (unlicensed)
    100 to 200micrograms/kg twice daily.

    Patients with Renal Impairment

    The Renal Drug Handbook suggests the following dose adjustments in renal impairment according to glomerular filtrate rate (GFR).

    GFR of 10 to 50ml/minute
    50% of the normal dose

    GFR of less than 10ml/minute
    Avoid use of amiloride


    Hyperkalaemia where serum potassium over 5.5mmol / l
    Acute renal failure
    Addison's disease
    Diabetic nephropathy
    Renal impairment - glomerular filtration rate below 10ml/minute
    Severe progressive renal disorder

    Precautions and Warnings

    Cardiopulmonary disorder
    Children under 18 years
    Diabetes mellitus
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    Hereditary fructose intolerance
    Lactose intolerance
    Metabolic acidosis
    Metabolic alkalosis
    Raised blood urea
    Renal impairment - glomerular filtration rate 10 - 50ml/minute
    Respiratory acidosis
    Severe hepatic disorder

    Reduce dose in patients with glomerular filtration rate 10-50ml/min
    Advise ability to drive/operate machinery may be affected by side effects
    Not all available products are licensed for all age groups
    Oral solution with maltitol unsuitable in hereditary fructose intolerance
    Some formulations contain hydroxybenzoate
    Some formulations contain lactose
    Monitor blood urea
    Monitor serum electrolytes
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    Discontinue treatment before glucose tolerance test
    May affect results of some laboratory tests
    Discontinue if hyperkalaemia occurs
    Advise patient not to take NSAIDs unless advised by clinician
    Hypotensive effect enhanced by alcohol
    Advise on problems of salt substitutes/high intake of potassium-rich food

    Determine renal function prior to therapy in patients with or suspected of having diabetes mellitus. Discontinue amiloride at least 3 days before a glucose-tolerance test.

    Particular caution should be used in severely ill patients who may develop respiratory or metabolic acidosis (e.g. cardiopulmonary disease or decompensated diabetes). Acidosis may be associated with rapid increases in plasma potassium and therefore these patients may experience an altered balance of intracellular-extracellular potassium.

    Monitor patients for signs of hyperkalaemia. Clinical, laboratory and ECG observations should be performed.
    Particular care should be taken with the elderly and patients with hepatic cirrhosis or cardiac oedema with known renal involvement, or those undergoing vigorous diuretic therapy.

    Patients with hepatic cirrhosis are more likely to experience side effects as they are less tolerant of shifts in electrolyte balance. Higher rates of encephalopathy, manifested by tremors, confusion, coma and increased jaundice may be seen in these patients.

    Pregnancy and Lactation


    Amiloride hydrochloride is contraindicated during pregnancy.

    The routine use of diuretics in the treatment of gestational hypertension is not indicated due to risk of hypovolaemia. Amiloride does not appear to show evidence of risk when used for indications other than preeclampsia and gestational hypertension (Briggs, 2015)

    Animal studies using amiloride in mice and rabbits at respectively 25 and 20 times the maximum recommended human dose found no evidence of foetal harm. The combination of amiloride and acetazolamide, however, resulted in abnormal development of the ureter and kidney in mice (Briggs, 2015).

    Amiloride is known to cross the placenta in mice and rabbits. There are limited reports describing the passage of amiloride across the human placenta. The molecular weight (about 230 for the free base) is low enough that transfer to the human foetus should be expected (Briggs, 2015).

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Amiloride hydrochloride is contraindicated in breastfeeding.

    It is unknown whether amiloride is excreted in human breast milk. The molecular weight (about 230 for the free base) is low enough, that passage into the milk should be expected (Briggs, 2015). Milk production can decrease with the use of diuretics, especially if there is an existing lactation deficiency.

    Amiloride is excreted in the milk of lactating rats at concentrations higher than that measured in blood (Hale, 2011).

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Abnormal liver function
    Abnormal liver function tests
    Aggravation of peptic ulcer
    Angina pectoris
    Aplastic anaemia
    Back pain
    Bladder spasm
    Chest pain
    Dry mouth
    Gastro-intestinal haemorrhage
    Heart block
    Increased frequency of micturition
    Increased intra-ocular pressure
    Increased thirst
    Increased uric acid level
    Joint pain
    Minor psychiatric disturbances
    Muscular cramps
    Nasal congestion
    Neck pain
    Orthostatic hypotension
    Painful extremities
    Reduced libido
    Shoulder pain
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: December 2016

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

    Summary of product characteristics: Amilamont 5mg/5ml Oral Solution. Rosemont Pharmaceuticals Limited. Revised March 2016.

    Summary of product characteristics: Amiloride Tablets BP 5mg. Actavis UK Ltd. Revised September 2016.

    Summary of product characteristics: Amiloride Tablets 5mg. Wockhardt UK Ltd. Revised August 2015.

    NICE Evidence Services Available at: Last accessed: 20 June 2017

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.