Slow-K (Potassium Chloride) - Indications and Dosage

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For therapeutic use in patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
   
2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

      The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

DOSAGE AND ADMINISTRATION

The usual dietary intake of potassium by the average adult is 50-100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

      Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-l00 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given, such that no more than 20 mEq is given in a single dose.

      One Slow-K tablet provides 8 mEq of potassium chloride.

      Slow-K should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).

Note: Slow-K extended-release tablets must be swallowed whole and never crushed, chewed, or sucked.

HOW SUPPLIED

Tablets – 600 mg of potassium chloride (equivalent to 8 mEq) round, buff-colored, sugar-coated (imprinted Slow-K)

      Bottles of 100……………………………………………………………….      NDC 0078-0320-05

      Bottles of 1000……………………………………………………………...      NDC 0078-0320-09

Do not store above 86 °F (30 °C). Protect from moisture.

Protect from light.

Dispense in tight, light-resistant container (USP).

                T2004-43

REV: APRIL 2004     

Distributed by

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936