"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
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.
- For the therapeutic use 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.
- 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 potassium intake by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more 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- 10 0 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 Klor-Con® (potassium chloride) Extended-release Tablet provides 8 mEq or 10 mEq of potassium chloride.
Klor-Con® (Potassium Chloride Extended-release Tablets, USP) 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: Klor-Con® (potassium chloride) Extended-release Tablets must be swallowed whole and never crushed, chewed or sucked.
Film-coated Klor-Con® (potassium chloride) 8 (blue), Klor-Con® (potassium chloride) 10 (yellow), imprinted round tablets containing:
600 mg potassium chloride (equivalent to 8 mEq) in bottles of 100 (NDC 0245- 0040-11), bottles of 500 (NDC 0245-0040-15), unit dose packages of 100 (NDC 0245-0040-01) and bulk packs of 5,000 for repack only (NDC 0245-0040-55); 750 mg potassium chloride (equivalent to 10 mEq) in bottles of 100 (NDC 0245- 0041-11), bottles of 500 (NDC 0245-0041-15), unit dose packages of 100 (NDC 0245-0041-01) and bulk packs of 5,000 for repack only (NDC 0245-0041-55).
Store at controlled room temperature, 15-30°C (59-86°F). Protect from light and moisture. Dispense in a tight container with child-resistant closure.
Manufactured by UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447. Revised 0105. FDA Rev date: 4/13/2006This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/19/2010
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