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Basic Drug Info
Drug Name:Amiloride Hydrochloride
Manufacturer:Par Pharmaceutical Co
Other Info:



Clinical Trials:


Indications and Usage

Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to:help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic.

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 has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.Amiloride HCl 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, result in an increased risk of hyperkalemia (approximately 10% with amiloride).

Amiloride HCl 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.
Congestive heart failure -- complication of heart diseases; defective cardiac filling and/or impaired contraction and emptying, resulting in the heart's inability to pump a sufficient amount of blood to meet the needs of the body tissues or to be able to do so only with an elevated filling pressure.

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

cardiac arrhythmia -- any variation from the normal rhythm or rate of the heart beat.

Uncomplicated Hypertension --

Essential Hypertension -- hypertension occurring without preexisting renal disease or known organic cause.

Contraindications

Hyperkalemia Amiloride HCl should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter).Antikaliuretic Therapy or Potassium SupplementationAmiloride HCl 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 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 FunctionAnuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of amiloride HCl.

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.HypersensitivityAmiloride HCl is contraindicated in patients who are hypersensitive to this product.
Chronic Kidney Insufficiency -- Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

Diabetic Nephropathy -- KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE.

Diabetes Mellitus -- A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal.

Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic.

This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly.

When amiloride is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2%.

It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function.
Branded Drugs
The following US Branded drugs contain Amiloride Hydrochloride


MIDAMOR -- PADDOCK LABORATORIES INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- BARR LABORATORIES INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- MYLAN PHARMACEUTICALS INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- SANDOZ INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- TEVA PHARMACEUTICALS USA INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE -- WATSON LABORATORIES INC

HYDRO-RIDE -- PAR PHARMACEUTICAL INC

MODURETIC 5-50 -- MERCK RESEARCH LABORATORIES DIV MERCK CO INC


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