Moduretic (Amiloride Hydrochloride / Hydrochlorothiazide) - Indications and Dosage

INDICATIONS AND USAGE

MODURETIC is indicated in those patients with hypertension or with congestive heart failure who develop hypokalemia when thiazides or other kaliuretic diuretics are used alone, or in whom maintenance of normal serum potassium levels is considered to be clinically important, 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.

MODURETIC may be used alone or as an adjunct to other antihypertensive drugs, such as methyldopa or beta blockers. Since MODURETIC enhances the action of these agents, dosage adjustments may be necessary to avoid an excessive fall in blood pressure and other unwanted side effects.

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked.

DOSAGE AND ADMINISTRATION

MODURETIC should be administered with food.

The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of MODURETIC daily usually are not needed and there is no controlled experience with such doses. Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents.

The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

HOW SUPPLIED

No. 3385--Tablets MODURETIC are peach-colored, diamond-shaped, scored, compressed tablets, coded MSD 917 on one side and M on the other. Each tablet contains 5 mg of anhydrous amiloride HCl and 50 mg of hydrochlorothiazide. They are supplied as follows:

NDC 0006-0917-68 in bottles of 100.

STORAGE

Keep container tightly closed. Protect from light, moisture, freezing, -20°C (-4°F) and store at room temperature, 15-30°C (59-86°F).

7887329 Issued November 2002

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