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Potassium Chloride Extended Release Tablets

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Potassium Chloride Extended Release Tablets

INDICATIONS

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-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 the treatment of 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, eg, 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 to 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 40-100 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.

Each Potassium Chloride Extended Release Tablet, USP 20 mEq provides 20 mEq of potassium chloride.

Each Potassium Chloride Extended Release Tablet, USP 10 mEq 10 tablet provides 10 mEq of potassium chloride.

Potassium Chloride Tablets 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).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

  1. Break the tablet in half, and take each half separately with a glass of water.
  2. Prepare an aqueous (water) suspension as follows:
    1. Place the whole tablet(s) in approximately 1 /2 glass of water (4 fluid ounces).
    2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
    3. Stir for about half a minute after the tablet(s) has disintegrated.
    4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
    5. Add another 1 fluid ounce of water, swirl, and consume immediately.
    6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of Potassium Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Potassium Chloride Tablets is not recommended.

HOW SUPPLIED

Potassium Chloride Extended Release Tablets, USP 20mEq are available in bottles of 100 (NDC 0085-0787-01); bottles of 500 (NDC 0085-0787-06); bottles of 1000 (NDC 0085-0787-10); and boxes of 100 for unit dose dispensing (NDC 0085- 0787-81).

Potassium Chloride Extended Release Tablets, USP 20 mEq are white to off-white capsule-shaped tablets imprinted W-1714 and scored on the other side.

Potassium Chloride Extended Release Tablets, USP 10mEq are available in bottles of 100 (NDC 0085-0263-01) and boxes of 100 for unit dose dispensing (NDC 0085-0263-81). Potassium Chloride Extended Release Tablets, USP 10mEq are white to off-white capsule-shaped tablets imprinted W-1715 on one side and plain on the other side.

Storage Conditions: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Schering Corporation, Kenilworth, NJ 07033 USA. Rev. 8/06. FDA rev date: 6/13/2008

Last reviewed on RxList: 9/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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