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Midamor (Amiloride Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

MIDAMOR is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension to:

  1. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic
  2. 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. MIDAMOR has little additive diuretic or antihypertensive effect when added to a thiazide diuretic.

MIDAMOR should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects. Used as single agents, potassium sparing diuretics, including MIDAMOR, result in an increased risk of hyperkalemia (approximately 10% with amiloride). MIDAMOR 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.

DOSAGE AND ADMINISTRATION

MIDAMOR should be administered with food.

MIDAMOR, 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 MIDAMOR 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 MIDAMOR should be re-evaluated. Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

If it is necessary to use MIDAMOR alone (see INDICATIONS), 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.

HOW SUPPLIED

Tablets MIDAMOR, 5 mg, are yellow, diamond-shaped, compressed tablets, coded MSD 92 on one side and MIDAMOR on the other. They are supplied as follows:

NDC 0574-0291-01 bottles of 100.

Storage

Protect from moisture, freezing and excessive heat.

Paddock Laboratories, Inc.
Minneapolis, MN 55427

(10-08)

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