MIDAMOR 5.0 MG — DIN 02249510

What is MIDAMOR?

MIDAMOR 5.0 MG contains AMILORIDE HYDROCHLORIDE : 5.0 MG. It is listed in the Health Canada Drug Product Database under DIN 02249510, held by AA PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 04-Apr-2011. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MIDAMOR used for?

MIDAMOR (amiloride hydrochloride tablets) is indicated: • For use alone or concomitantly with thiazide diuretics or other kaliuretic-diuretic agents in the treatment of patients with cirrhosis of the liver with ascites and edema. • As an adjunct to thiazide diuretics or other kaliuretic-diuretic agents for the treatment of edema of cardiac origin or of hypertension in patients who have hypokalemia, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, patients in whom adequate dietary intake of potassium is not feasible, or patients with cardiac arrhythmias. Use in Hepatic Cirrhosis with Ascites and Edema MIDAMOR used alone may provide satisfactory diuresis with diminished potassium loss and with a reduced risk of metabolic alkalosis. In resistant cases MIDAMOR may be used with kaliuretic-diuretic agents to help produce satisfactory diuresis, while maintaining a more balanced serum electrolyte pattern. As with all therapy for the ascites of hepatic cirrhosis, gradual weight loss and avoidance of electrolyte imbalance are the chief objectives.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Hepatic Cirrhosis with Ascites and Edema Treatment should be started with a small dose of MIDAMOR, i.e., one 5 mg tablet daily, plus a small dose of a diuretic agent (other than antikaliuretics). If necessary, dosages of both drugs may be increased gradually until effective diuresis is obtained. The dosage of MIDAMOR should not exceed four tablets (20 mg) a day. Maintenance doses may be lower than those required to initiate diuresis; therefore, reduction in the daily dosage should be attempted when the patient's weight is stabilized. In cirrhotic patients, gradual weight reduction is especially desirable to reduce the likelihood of untoward reactions associated with diuretic therapy. In those instances where MIDAMOR is used alone, the initial daily dosage should be two 5 mg tablets (as a single dose or one tablet twice a day). Dosage may be increased depending on the need. The total daily dosage should not exceed four tablets (20 mg). After diuresis has been achieved the dosage may be reduced by decrements of one tablet to the least amount required. Edema of Cardiac Origin MIDAMOR, one or two 5 mg tablets daily, may be given with the usual doses of a diuretic agent (other than antikaliuretics). This dose is sufficient in most cases. If potassium levels remain low, the dosage of MIDAMOR can be increased gradually. The dosage of MIDAMOR should not exceed four tablets (20 mg) a day. The optimal dosage is determined by the serum potassium level. Reduction in dosage should be attempted for maintenance therapy. Maintenance therapy may be on an intermittent basis. Hypertension MIDAMOR, one or two 5 mg tablets daily, is given with the usual antihypertensive dosage of a diuretic agent (other than antikaliuretics). The dosage may be adjusted if necessary. More than two 5 mg tablets of MIDAMOR daily usually is not needed; in any event, the maximum dosage is four tablets (20 mg) a day. Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

MIDAMOR is contraindicated in the following conditions: • Hypersensitivity: Patients with known hypersensitivity to amiloride or other derivatives, or to any ingredient in the formulation, including any non-medical ingredient, or component of the container. • Hyperkalemia: MIDAMOR should not be used in the presence of elevated serum potassium levels. • Antikaliuretic Therapy or Potassium Salts: Other antikaliuretic agents and potassium supplements are contraindicated in patients receiving amiloride hydrochloride (such combination therapy is commonly associated with rapid increases in plasma potassium levels). • Impaired Renal Function: Anuria, acute renal failure, severe or progressive renal disease, and diabetic nephropathy are contraindications to the use of MIDAMOR.

Warnings and precautions

Serious Warnings and Precautions Box Hyperkalemia • Hyperkalemia (i.e., serum potassium levels over 5.5 mEq/L), has been observed in patients who received amiloride hydrochloride tablets either alone or with diuretics. This has been noted particularly in elderly patients, in diabetic patients, and in hospitalized patients with hepatic cirrhosis or cardiac edema who had known renal impairment, were seriously ill, or were receiving vigorous diuretic therapy. Since fatalities have occurred, patients should be monitored carefully for clinical, laboratory, and electrocardiographic (ECG) evidence of hyperkalemia and for acidosis. Monitoring of the serum potassium level is important because hyperkalemia is not always associated with an abnormal ECG. Warning signs or symptoms of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, shock, and ECG abnormalities. Driving and Operating Machinery The effect of MIDAMOR on ability to drive and operate machinery has not been studied. However, since its use has been associated with dizziness, weakness, visual disturbances, vertigo, orthostatic hypotension and somnolence, patients should be cautioned not to drive, operate dangerous machinery or engage in activities that require alertness or physical coordination if they are experiencing any of these effects. Endocrine and Metabolism Hyperkalemia: The risk of hyperkalemia may be increased when potassium-conserving agents, including amiloride hydrochloride, are administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus. 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. If hyperkalemia occurs in patients taking MIDAMOR, 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 commonly reported with the use of amiloride hydrochloride, particularly if they have chronic renal disease or prerenal azotemia. Some deaths occurred in this last group of patients. Therefore, if therapy with MIDAMOR is considered essential, the drug should be used with caution in diabetic or suspected diabetic patients and only after first determining the status of renal function. Careful monitoring of serum potassium levels is required throughout the therapy. One patient with poorly controlled diabetes mellitus who became severely hyperkalemic while on amiloride hydrochloride died following two repeated intravenous glucose tolerance tests. Therefore, MIDAMOR should be discontinued at least 3 days before glucose tolerance testing. Metabolic or Respiratory Acidosis: Antikaliuretic therapy should be instituted only with caution in patients in whom respiratory or metabolic acidosis may occur, such as patients with cardiopulmonary disease or diabetes. If MIDAMOR 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.