ect of the diuretic is obtained. since indomethacin and potassium-sparing diuretics, including amiloride hcl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

lt 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, the drug should be discontinued immediately. if the serum potassium level exceeds 6.5 meq per liter, active measures should be taken to reduce it. such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. if needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. patients with persistent hyperkalemia may require dialysis. 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.

er 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.

ited 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. incidence > 1% incidence ≤ 1% body as a whole headache* back pain weakness chest pain fatigability neck/shoulder ache pain, extremities cardiovascular none angina pectoris orthostatic hypotension arrhythmia palpitation digestive nausea/anorexia* jaundice diarrhea* gi bleeding vomiting* abdominal fullness abdominal pain gi disturbance gas pain thirst appetite changes heartburn constipation flatulence dyspepsia metabolic elevated serum potassium levels (>5.5 meq per liter)** none skin none skin rash itching dryness of mouth pruritus alopecia musculoskeletal muscle cramps joint pain leg ache nervous dizziness paresthesia encephalopathy tremors vertigo psychiatric none nervousness mental confusion insomnia decreased libido depression somnolence respiratory cough shortness of breath dyspnea special senses none visual disturbances nasal congestion tinnitus increased intraocular pressure urogenital impotence polyuria dysuria urinary frequency bladder spasms gynecomastia *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 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 to report suspected adverse reactions, contact sigmapharm laboratories, llc, pharmacovigilance at 1-855-332-0731 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

ect of the diuretic is obtained. since indomethacin and potassium-sparing diuretics, including amiloride hcl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

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.