Amiloride

Indications

INDICATIONS AND USAGE 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).

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 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.

Contraindications

CONTRAINDICATIONS 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.

Warnings and precautions

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 PRECAUTIONS , Drug Interactions. ) 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.

Pregnancy

Pregnancy Pregnancy Category B . Teratogenicity studies with amiloride HCl in rabbits and mice given 20 and 25 times the maximum human dose, respectively, revealed no evidence of harm to the fetus, although studies showed that the drug crossed the placenta in modest amounts.

Storage and supply

HOW SUPPLIED 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 in bottles of 100’s (NDC #42794-005-02). Store at 20°-25°C (68°-77°F) . Dispense in a tight, light-resistant container as defined in the USP.

Source: Amiloride Hydrochloride (Amiloride Hydrochloride) — US FDA prescribing information, 2023-01-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.