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Amiloride Hydrochloride
Overview
What is Amiloride Hydrochloride?
Amiloride HCl, an antikaliuretic-diuretic agent, is a
pyrazine-carbonyl-guanidine that is unrelated chemically to other known
antikaliuretic or diuretic agents. It is the salt of a moderately strong base
(pKa 8.7). It is designated chemically as
3,5-diamino-6-chloro-N-(diaminomethylene) pyrazinecarboxamide monohydrochloride,
dihydrate and has a molecular weight of 302.12. Its empirical formula is C
H
CIN
O•HCl•2H
O and its structural formula
is:
Each tablet for oral administration contains 5 mg of Amiloride HCI, calculated
on the anhydrous basis. Each tablet contains the following inactive ingredients:
corn starch, crospovidone, lactose, magnesium stearate, microcrystalline
cellulose and povidone.
What does Amiloride Hydrochloride look like?
What are the available doses of Amiloride Hydrochloride?
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What should I talk to my health care provider before I take Amiloride Hydrochloride?
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How should I use Amiloride Hydrochloride?
Amiloride HCl tablets are indicated as adjunctive treatment with
thiazide diuretics or other kaliureticdiuretic agents in congestive heart
failure or hypertension to:
a. help restore normal serum potassium levels in patients who develop
hypokalemia on the kaliuretic diuretic
b. prevent development of hypokalemia in patients who would be exposed to
particular risk if hypokalemia were to develop, e.g., digitalized patients or
patients with significant cardiac arrhythmias.
The use of potassium-conserving agents is often unnecessary in patients
receiving diuretics for uncomplicated essential hypertension when such patients
have a normal diet. Amiloride HCl tablets have little additive diuretic or
antihypertensive effect when added to a thiazide diuretic.
Amiloride HCl tablets should rarely be used alone. It has weak (compared with
thiazides) diuretic and antihypertensive effects. Used as single agents,
potassium sparing diuretics, including amiloride HCl tablets, result in an
increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl tablets should be used alone only when persistent hypokalemia has been
documented and only with careful titration of the dose and close monitoring of
serum electrolytes.
Amiloride HCl tablets should be administered with food.
Amiloride HCl tablets, one 5 mg tablet daily, should be added to the usual
antihypertensive or diuretic dosage of a kaliuretic diuretic. The dosage may be
increased to 10 mg per day, if necessary. More than two 5 mg tablets of
amiloride HCl daily usually are not needed, and there is little controlled
experience with such doses. If persistent hypokalemia is documented with 10 mg,
the dose can be increased to 15 mg, then 20 mg, with careful monitoring of
electrolytes.
In treating patients with congestive heart failure after an initial diuresis
has been achieved, potassium loss may also decrease and the need for amiloride
HCl tablets should be re-evaluated. Dosage adjustment may be necessary.
Maintenance therapy may be on an intermittent basis.
If it is necessary to use amiloride HCl tablets alone (see
), the starting dosage should be one 5 mg
tablet daily. This dosage may be increased to 10 mg per day, if necessary. More
than two 5 mg tablets usually are not needed, and there is little controlled
experience with such doses. If persistent hypokalemia is documented with 10 mg,
the dose can be increased to 15 mg, then 20 mg, with careful monitoring of
electrolytes.
What interacts with Amiloride Hydrochloride?
Hyperkalemia
Amiloride HCl tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).
Antikaliuretic Therapy or Potassium Supplementation
Amiloride HCl tablets should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet should not be used with amiloride HCl tablets except in severe and/or refractory cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary.
Impaired Renal Function
Anuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of amiloride HCl tablets. Patients with evidence of renal functional impairment (blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or diabetes mellitus should not receive the drug without careful, frequent and continuing monitoring of serum electrolytes, creatinine, and BUN levels. Potassium retention associated with the use of an antikaliuretic agent is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia.
Hypersensitivity
Amiloride HCl tablets are contraindicated in patients who are hypersensitive to this product.
Array
WARNINGS
What are the warnings of Amiloride Hydrochloride?
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What are the precautions of Amiloride Hydrochloride?
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What are the side effects of Amiloride Hydrochloride?
Amiloride HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq liter - see WARNINGS), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride are generally those known to be associated with diuresis, or with the underlying disease being treated.
The adverse reactions for amiloride HCl listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with amiloride HCl). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride HCl and these adverse reactions, some of which have been reported only rarely.
Causal Relationship Unknown
Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.
Activation of probable pre-existing peptic ulcer
Aplastic anemia
Neutropenia
Abnormal liver function
| *Reactions occurring in 3% to 8% of patients treated with amiloride HCl. | |
| (Those reactions occurring in less than 3% of the patients are unmarked.) | |
| **See WARNINGS. | |
What should I look out for while using Amiloride Hydrochloride?
Hyperkalemia
Amiloride HCl tablets should not be used in the presence of elevated serum
potassium levels (greater than 5.5 mEq per liter).
Antikaliuretic Therapy or Potassium
Supplementation
Amiloride HCl tablets should not be given to patients receiving other
potassium-conserving agents, such as spironolactone or triamterene. Potassium
supplementation in the form of medication, potassium-containing salt substitutes
or a potassium-rich diet should not be used with amiloride HCl tablets except in
severe and/or refractory cases of hypokalemia. Such concomitant therapy can be
associated with rapid increases in serum potassium levels. If potassium
supplementation is used, careful monitoring of the serum potassium level is
necessary.
Impaired Renal Function
Anuria, acute or chronic renal insufficiency, and evidence of diabetic
nephropathy are contraindications to the use of amiloride HCl tablets. Patients
with evidence of renal functional impairment (blood urea nitrogen [BUN] levels
over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or
diabetes mellitus should not receive the drug without careful, frequent and
continuing monitoring of serum electrolytes, creatinine, and BUN levels.
Potassium retention associated with the use of an antikaliuretic agent is
accentuated in the presence of renal impairment and may result in the rapid
development of hyperkalemia.
Hypersensitivity
Amiloride HCl tablets are contraindicated in patients who are hypersensitive
to this product.
WARNINGS
The risk of hyperkalemia may be increased when
potassium-conserving agents, including amiloride HCl, are administered
concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II
receptor antagonist, cyclosporine or tacrolimus. (See
,
) Warning signs or symptoms of
hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis
of the extremities, bradycardia, shock, and ECG abnormalities. Monitoring of the
serum potassium level is essential because mild hyperkalemia is not usually
associated with an abnormal ECG.
When abnormal, the ECG in hyperkalemia is characterized primarily by tall,
peaked T waves or elevations from previous tracings. There may also be lowering
of the R wave and increased depth of the S wave, widening and even disappearance
of the P wave, progressive widening of the QRS complex, prolongation of the PR
interval, and ST depression.
Treatment of hyperkalemia:
Diabetes Mellitus
In diabetic patients, hyperkalemia has been reported with the use of all
potassium-conserving diuretics, including amiloride HCl, even in patients
without evidence of diabetic nephropathy. Therefore, amiloride HCl should be
avoided, if possible, in diabetic patients and, if it is used, serum
electrolytes and renal function must be monitored frequently.
Amiloride HCl should be discontinued at least 3 days before glucose tolerance
testing.
Metabolic or Respiratory Acidosis
Antikaliuretic therapy should be instituted only with caution in severely ill
patients in whom respiratory or metabolic acidosis may occur, such as patients
with cardiopulmonary disease or poorly controlled diabetes. If amiloride HCl is
given to these patients, frequent monitoring of acid-base balance is necessary.
Shifts in acid-base balance alter the ratio of extracellular/intracellular
potassium, and the development of acidosis may be associated with rapid
increases in serum potassium levels.
What might happen if I take too much Amiloride Hydrochloride?
No data are available in regard to overdosage in humans.
The oral LD
of amiloride HCl (calculated as the
base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the
strain.
It is not known whether the drug is dialyzable.
The most likely signs and symptoms to be expected with overdosage are
dehydration and electrolyte imbalance. These can be treated by established
procedures. Therapy with amiloride HCl should be discontinued and the patient
observed closely. There is no specific antidote.Emesis should be induced or
gastric lavage performed.Treatment is symptomatic and supportive. If
hyperkalemia occurs, active measures should be taken to reduce the serum
potassium levels.
How should I store and handle Amiloride Hydrochloride?
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.Each yellow round compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “ Σ ” on one side and “5” on the other. They are available as follows: NDC 50268-071-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Pulaski, TN 38478 Mfg. Rev. 02/09 AV Rev. 09/16 (P) AvPAK Each yellow round compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “ Σ ” on one side and “5” on the other. They are available as follows: NDC 50268-071-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Pulaski, TN 38478 Mfg. Rev. 02/09 AV Rev. 09/16 (P) AvPAK Each yellow round compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “ Σ ” on one side and “5” on the other. They are available as follows: NDC 50268-071-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Pulaski, TN 38478 Mfg. Rev. 02/09 AV Rev. 09/16 (P) AvPAK Each yellow round compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “ Σ ” on one side and “5” on the other. They are available as follows: NDC 50268-071-15 (10 tablets per card, 5 cards per carton). Dispensed in Unit Dose Package. For Institutional Use Only. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured for: Pulaski, TN 38478 Mfg. Rev. 02/09 AV Rev. 09/16 (P) AvPAK
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Amiloride HCl is a potassium-conserving (antikaliuretic) drug
that possesses weak (compared with thiazide diuretics) natriuretic, diuretic,
and antihypertensive activity. These effects have been partially additive to the
effects of thiazide diuretics in some clinical studies. When administered with a
thiazide or loop diuretic, amiloride has been shown to decrease the enhanced
urinary excretion of magnesium which occurs when a thiazide or loop diuretic is
used alone. Amiloride has potassium-conserving activity in patients receiving
kaliureticdiuretic agents.
Amiloride HCl is not an aldosterone antagonist and its effects are seen even
in the absence of aldosterone.
Amiloride exerts its potassium sparing effect through the inhibition of
sodium reabsorption at the distal convoluted tubule, cortical collecting tubule
and collecting duct; this decreases the net negative potential of the tubular
lumen and reduces both potassium and hydrogen secretion and their subsequent
excretion. This mechanism accounts in large part for the potassium sparing
action of amiloride.
Amiloride usually begins to act within 2 hours after an oral dose. Its effect
on electrolyte excretion reaches a peak between 6 and 10 hours and lasts about
24 hours. Peak plasma levels are obtained in 3 to 4 hours and the plasma
half-life varies from 6 to 9 hours. Effects on electrolytes increase with single
doses of amiloride HCl up to approximately 15 mg.
Amiloride HCl is not metabolized by the liver but is excreted unchanged by
the kidneys. About 50 percent of a 20 mg dose of amiloride HCl is excreted in
the urine and 40 percent in the stool within 72 hours. Amiloride has little
effect on glomerular filtration rate or renal blood flow. Because amiloride HCl
is not metabolized by the liver, drug accumulation is not anticipated in
patients with hepatic dysfunction, but accumulation can occur if the hepatorenal
syndrome develops.
Non-Clinical Toxicology
HyperkalemiaAmiloride HCl tablets should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).
Antikaliuretic Therapy or Potassium Supplementation
Amiloride HCl tablets should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet should not be used with amiloride HCl tablets except in severe and/or refractory cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary.
Impaired Renal Function
Anuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of amiloride HCl tablets. Patients with evidence of renal functional impairment (blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or diabetes mellitus should not receive the drug without careful, frequent and continuing monitoring of serum electrolytes, creatinine, and BUN levels. Potassium retention associated with the use of an antikaliuretic agent is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia.
Hypersensitivity
Amiloride HCl tablets are contraindicated in patients who are hypersensitive to this product.
WARNINGS
The risk of hyperkalemia may be increased when potassium-conserving agents, including amiloride HCl, are administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus. (See , ) Warning signs or symptoms of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, shock, and ECG abnormalities. Monitoring of the serum potassium level is essential because mild hyperkalemia is not usually associated with an abnormal ECG.
When abnormal, the ECG in hyperkalemia is characterized primarily by tall, peaked T waves or elevations from previous tracings. There may also be lowering of the R wave and increased depth of the S wave, widening and even disappearance of the P wave, progressive widening of the QRS complex, prolongation of the PR interval, and ST depression.
Treatment of hyperkalemia:
Diabetes Mellitus
In diabetic patients, hyperkalemia has been reported with the use of all potassium-conserving diuretics, including amiloride HCl, even in patients without evidence of diabetic nephropathy. Therefore, amiloride HCl should be avoided, if possible, in diabetic patients and, if it is used, serum electrolytes and renal function must be monitored frequently.
Amiloride HCl should be discontinued at least 3 days before glucose tolerance testing.
Metabolic or Respiratory Acidosis
Antikaliuretic therapy should be instituted only with caution in severely ill patients in whom respiratory or metabolic acidosis may occur, such as patients with cardiopulmonary disease or poorly controlled diabetes. If amiloride HCl is given to these patients, frequent monitoring of acid-base balance is necessary. Shifts in acid-base balance alter the ratio of extracellular/intracellular potassium, and the development of acidosis may be associated with rapid increases in serum potassium levels.
Electrolyte Imbalance and BUN Increases
Hyponatremia and hypochloremia may occur when amiloride HCl is used with other diuretics and increases in BUN levels have been reported. These increases usually have accompanied vigorous fluid elimination, especially when diuretic therapy was used in seriously ill patients, such as those who had hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant edema. Therefore, when amiloride HCl is given with other diuretics to such patients, careful monitoring of serum electrolytes and BUN levels is important. In patients with pre-existing severe liver disease, hepatic encephalopathy, manifested by tremors, confusion, and coma, and increased jaundice, have been reported in association with diuretics, including amiloride HCl.
Amiloride HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq liter - see ), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride are generally those known to be associated with diuresis, or with the underlying disease being treated.
The adverse reactions for amiloride HCl listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with amiloride HCl). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride HCl and these adverse reactions, some of which have been reported only rarely.
*Reactions occurring in 3% to 8% of patients treated with amiloride HCl.
(Those reactions occurring in less than 3% of the patients are unmarked.)
**See
Causal Relationship Unknown
Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.
Activation of probable pre-existing peptic ulcer
Aplastic anemia
Neutropenia
Abnormal liver function
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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