amiloride hydrochloride * 5 mg ; oral use ; tablet

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2013

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Marketed drugs :
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ATC Reproductive health Sport Vigilance
C CARDIOVASCULAR SYSTEM
C03 DIURETICS
C03D POTASSIUM-SPARING AGENTS
C03DB OTHER POTASSIUM-SPARING AGENTS
C03DB01 AMILORIDE
Pregnancy (months) Lactation
1 2 3 4 5 6 7 8 9
Risk III III

IIIRelative contraindication

Use and administration

amiloride hydrochloride * 5 mg ; oral use ; tablet

Indications

This generic drug is indicated in the following cases:

  • Cirrhotic ascites
  • Cirrhotic edema
  • Edema in heart failure
  • Preventive treatment for iatrogenic hypokalemia in hypertensive patients on diuretics

Dosage

Oral use.
Once diuresis has started, the dose may be reduced to the lowest effective dose.
Maximum dose: 20 mg daily.
-- Adults:
- In monotherapy:
10 mg daily as a single or in 2 divided doses, increased if necessary.
- Used in combination with another diuretic treatment:
. Cardiac edemas: 5-10 mg daily; gradually increased if necessary.
. Hypertension: 5-10 mg daily, increased if necessary.
. Cirrhotic ascites: 5 mg daily, increased if necessary.

Treatment monitoring

  • Monitor renal function before and during treatment
  • Monitor serum electrolytes before and during treatment
  • Perform clinical monitoring during treatment

Patient safety

amiloride hydrochloride * 5 mg ; oral use ; tablet
Risk scale: XCritical IIIHigh IIModerate ILow

Drug interactions

XCritical

Severity: Contraindication

Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Eplerenone
Risks and Mechanisms Potentially lethal hyperkalemia, particularly in patients with renal failure (addition of hyperkaliemic effects).
Course of Action Contraindication except if there is hypokalemia.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Potassium
Risks and Mechanisms Potentially lethal hyperkalemia particularly in renal failure (addition of hyperkalemic effects).
Course of Action Contraindication: except in case of hypokalemia or when using parenteral potassium salts. Combination not recommended: in case of hypokalemia or when using parenteral potassium salts.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone
Risks and Mechanisms Potentially lethal hyperkalemia, particularly in patients with renal failure (addition of hyperkaliemic effects).
Course of Action Contraindication except if there is hypokalemia.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Spironolactone
Risks and Mechanisms Potentially lethal hyperkalemia, particularly in patients with renal failure (addition of hyperkaliemic effects).
Course of Action Contraindication except if there is hypokalemia.
IIIHigh

Severity: Combination not recommended

Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Angiotensin II receptor antagonists
Risks and Mechanisms Except for eplerenone and for spironolactone at doses between 12.5 mg and 50 mg/day in the treatment of heart failure and also in the event of hypokaliemia: risk of hyperkalemia (potentially lethal) particularly during renal failure (addition of hyperkalemic effects).
Course of Action If the association is justified, strict monitoring of kaliemia and of renal function.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Angiotensin-converting enzyme inhibitors
Risks and Mechanisms Except for eplerenone and for spironolactone at doses between 12.5 mg and 50 mg/day in the treatment of heart failure and also in the event of hypokaliemia: risk of hyperkalemia (potentially lethal) particularly during renal failure (addition of hyperkalemic effects).
Course of Action If the association is justified, strict monitoring of kaliemia and of renal function.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Ciclosporin (systemic route)
Risks and Mechanisms Potentially lethal hyperkalemia particularly in renal failure (addition of hyperkalemic effects).
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Delapril
Risks and Mechanisms Except for eplerenone and spironolactone administered at doses between 12.5 and 50 mg per day in the treatment of cardiac failure, as well as in case of hypokalemia: risk of hyperkalemia (potentially lethal) especially in renal failure (addition of hyperkalemic effects).
Course of Action If the combination is justified, strict control of kalemia and renal function.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Enalaprilate
Risks and Mechanisms Except for eplerenone and for spironolactone at doses between 12.5 mg and 50 mg/day in the treatment of heart failure and also in the event of hypokaliemia: risk of hyperkalemia (potentially lethal) particularly during renal failure (addition of hyperkalemic effects).
Course of Action If the association is justified, strict monitoring of kaliemia and of renal function.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Tacrolimus (systemic route)
Risks and Mechanisms Potentially lethal hyperkalemia particularly in renal failure (addition of hyperkalemic effects).
IIModerate

Severity: Precaution

Antihypertensive agents + Baclofen
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Course of Action Monitor blood pressure and dose adjustment of the antihypertensive agent if necessary.
Diuretics + Acetylsalicylic acid (systemic route)
Risks and Mechanisms For anti-inflammatory doses of acetylsalicylic acid (>= 1 g per dose and/or >= 3 g per day) or for doses of analgesics and antipyretics (>= 500 mg per dose and/or < 3 g per day): acute renal failure in a dehydrated patient, due to reduced glomerular filtration secondary to the reduction of renal prostaglandin synthesis. Moreover, reduced antihypertensive effect.
Course of Action Hydrate the patient, monitor renal function at the start of the treatment.
Diuretics + Iodinated contrast media
Risks and Mechanisms In the event of diuretic-induced dehydration, increased risk of acute functional renal failure, particularly during the use of significant doses of iodine contrast products.
Course of Action Rehydration before administration of the iodine product.
Diuretics + Lornoxicam
Risks and Mechanisms Acute renal failure in patients at risk (elderly and/or dehydrated patients) due to reduced glomerular filtration (inhibition of vasodilator prostoglandins due to non-steroidal anti-inflammatory drugs). Moreover, reduced antihypertensive effect.
Course of Action Hydrate the patient, monitor renal function at the start of the treatment.
Diuretics + Non-steroidal anti-inflammatory drugs
Risks and Mechanisms Acute renal failure in patients at risk (elderly and/or dehydrated patients) due to reduced glomerular filtration (inhibition of vasodilator prostaglandins due to non-steroidal anti-inflammatory drugs). Moreover, reduced antihypertensive effect.
Course of Action Hydrate the patient, monitor renal function at the start of the treatment.
Diuretics + Tolfenamic acid
Risks and Mechanisms Acute renal failure in patients at risk (elderly and/or dehydrated patients) due to reduced glomerular filtration (inhibition of vasodilator prostoglandins due to non-steroidal anti-inflammatory drugs). Moreover, reduced antihypertensive effect.
Course of Action Hydrate the patient, monitor renal function at the start of the treatment.
Diuretics + Tolmetin
Risks and Mechanisms Acute renal failure in patients at risk (elderly and/or dehydrated patients) due to reduced glomerular filtration (inhibition of vasodilator prostoglandins due to non-steroidal anti-inflammatory drugs). Moreover, reduced antihypertensive effect.
Course of Action Hydrate the patient, monitor renal function at the start of the treatment.
Hyperkalemic agents + Enalaprilate
Risks and Mechanisms Risk of increased, potentially fatal, hyperkalemia.
Orally administered drugs + Cholestyramine
Risks and Mechanisms Cholestyramine can reduced intestinal absorption, and potentially, the effectiveness of other drugs taken at the same time. This interaction was proved for some substances or therapeutic classes (thyroid hormones, statins, digoxin, oral anticoagulants, hydrochlorothiazide, paracetamol, bile acids) but probably concerns also many other drugs.
Course of Action In general, cholestyramine should be taken sometime after the other drugs (more than two hours, if possible).
Orally administered drugs + Topical gastrointestinal agents, antacids and adsorbents
Risks and Mechanisms Reduced absorption of certain other drugs ingested simultaneously.
Course of Action As a precaution, these topical agents or antacids should be taken some time after any other drug (more than 2 hours, if possible).
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Epitizide
Risks and Mechanisms Rational combination, useful for some patients, which doesn't exclude hypokalemia or, particularly in renally impaired and diabetic patients, hyperkalemia.
Course of Action Monitor kalemia, possibly ECG and, if needed, reassess the treatment.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Hydroflumethiazide
Risks and Mechanisms Rational combination, useful for certain patients, does not exclude the onset of hypokalemia or hyperkalemia, particularly in patients with renal failure or diabetes.
Course of Action Monitor kalemia, possible ECG monitoring if necessary and reconsider the treatment.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Hypokalemic diuretics
Risks and Mechanisms Rational combination, useful for certain patients, does not exclude the onset of hypokalemia or hyperkalemia, particularly in patients with renal failure or diabetes.
Course of Action Monitor kalemia, possible ECG monitoring if necessary and reconsider the treatment.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Lithium
Risks and Mechanisms Increased lithemia with signs of lithium overdose, such as during a salt-free diet (reduced urinary excretion of lithium).
Course of Action Strict monitoring of lithemia and possible lithium dose adjustment.
Potassium-sparing diuretics (alone or in association) except spironolactone and eplerenone + Metolazone
Risks and Mechanisms Rational combination, useful for certain patients, does not exclude the onset of hypokalemia or hyperkalemia, particularly in patients with renal failure or diabetes.
Course of Action Monitor kalemia, possible ECG monitoring if necessary and reconsider the treatment.
ILow

Severity: Take into account

Antihypertensive agents + Amifostine
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents + Imipraminic antidepressants
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents + Melitracen
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents + Nesiritide
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents + Neuroleptics
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents + Nitrate and related derivatives
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents + Veralipride
Risks and Mechanisms Increased risk of hypotension, particularly orthostatic hypotension.
Antihypertensive agents except alpha-blockers + Alpha-blocker antihypertensive agents
Risks and Mechanisms Increased hypotensive effect. Increased risk of orthostatic hypotension.
Antihypertensive agents except alpha-blockers + Alpha-blockers for urological disorders
Risks and Mechanisms Increased hypotensive effect. Increased risk of orthostatic hypotension.
Antihypertensive agents except alpha-blockers + Doxazosin
Risks and Mechanisms Increased hypotensive effect. Risk of increased orthostatic hypotension.
Antihypertensive agents except alpha-blockers + Phenoxybenzamine
Risks and Mechanisms Increased hypotensive effect. Increased risk of orthostatic hypotension.
Antihypertensive agents except alpha-blockers + Phentolamine
Risks and Mechanisms Increased hypotensive effect. Increased risk of orthostatic hypotension.
Hyperkalemic agents + Bivalirudin
Risks and Mechanisms Risk of increased, potentially fatal, hyperkalemia.
Hyperkalemic agents + Delapril
Risks and Mechanisms Risk of increased hyperkalemia, potentially lethal.
Hyperkalemic agents + Hyperkalemic agents
Risks and Mechanisms Risk of increased, potentially fatal, hyperkalemia.
Course of Action To find out the risk and specific levels of constraint of hyperkalemic drugs, please refer to the interactions specific to each substance.
Hyperkalemic agents + Lornoxicam
Risks and Mechanisms Risk of increased, potentially fatal, hyperkalemia.
Hyperkalemic agents + Tolfenamic acid
Risks and Mechanisms Risk of increased, potentially fatal, hyperkalemia.
Hyperkalemic agents + Tolmetin
Risks and Mechanisms Risk of increased, potentially fatal, hyperkalemia.
Hyponatremic agents + Epitizide
Risks and Mechanisms Increased risk of hyponatremia.
Hyponatremic agents + Hydroflumethiazide
Risks and Mechanisms Increased risk of hyponatremia.
Hyponatremic agents + Hyponatremic agents
Risks and Mechanisms Increased risk of hyponatremia.

Contraindications

XCritical

Severity: Absolute contraindication

  • Hyperkalemia
  • Hypersensitivity to one of the components
  • Severe renal failure: creatinine clearance < 30 ml/min
IIIHigh

Severity: Relative contraindication

Precautions

IIModerate

Severity: Precaution

  • Acute limb ischemia
  • Alteration of general condition
  • Athlete
  • Children under 15 years old
  • Cirrhosis
  • Decompensated liver cirrhosis
  • Dehydration
  • Diabetes
  • Edema
  • Elderly patients
  • Heart failure
  • Intercurrent pathology
  • Metabolic acidosis
  • Pathology leading to cellular lysis
  • Patients at risk of hyperkalemia
  • Renal failure
  • Rhabdomyolysis
  • Severe trauma
  • Treatment with hyperkalemic drug

Pregnancy and lactation

Contraindications & Cautions
Pregnancy (months) Lactation
1 2 3 4 5 6 7 8 9
Risk III III

IIIRelative contraindication

Specific risks

  • Risk of encephalopathy
  • Risk of hyperkalemia
  • Risk of hypochloremic alkalosis
  • Risk of hyponatremia
  • Risk of increased serum urea levels

Adverse effects

System Medium to high frequency (≥1/1 000) Low frequency (<1/1 000) Unknown frequency
Cardiovascular system Orthostatic hypotension
Dermatology Pruritus
Skin rash
Digestive system Abdominal pain
Anorexia
Constipation
Diarrhea
Meteorism
Nausea
Vomiting
ENT, Stomatology Oligoptyalism
Laboratory tests abnormality Hyperkalemia
Hyponatremia
Musculo-skeletal system Cramp
Muscular fatigability
Muscular weakness
Nervous system Headache
Hepatic encephalopathy
Paresthesia
Sleepiness
Vertigo
Nutrition, Metabolism Polydipsia
Ophthalmology Visual changes
Other Chest pain
Psychiatry Mental confusion
Respiratory system Cough
Dyspnea

Marketed drugs

amiloride hydrochloride * 5 mg ; oral use ; tablet

List of branded products (UAE)

amiloride hydrochloride

Substance details

Chemistry

IUPAC chlorhydrate de 1-(3,5-diamino-6-chloropyrazinecarboxyl)guanidine
Synonyms amiloride hydrochloride

Dosage

Defined Daily Dose (WHO)
Oral : 10 mg