KLOR-CON/EF

Orange-flavored KLOR-CON ® /EF (potassium bicarbonate effervescent tablets for oral solution, USP) are an oral potassium supplement offered as effervescent tablets in individual packets for dissolution in water. Each tablet contains potassium bicarbonate 2.5 g and citric acid 2.1 g which in solution provides 25 mEq (978 mg) potassium as bicarbonate and citrate. Also contains: FD&C Yellow No. 6, FD&C Yellow No. 6 Lake, microcrystalline cellulose, mineral oil, orange flavor, saccharin and talc. KLOR-CON ® /EF tablets are sugar-free.

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. 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.

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 25 mEq per day. Doses of 50 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 25 mEq per day is given such that no more than 25 mEq is given in a single dose. The usual adult dose is 25 to 100 mEq of potassium per day (one KLOR-CON ® /EF tablet 1 to 4 times daily after meals). Each KLOR-CON ® /EF tablet should be dissolved in at least 4 ounces of cold or ice water. These preparations, like other potassium supplements, must be properly diluted to avoid the possibility of gastrointestinal irritation.

Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride) [see OVERDOSAGE ] .

One of the most severe adverse effects is hyperkalemia [see CONTRAINDICATIONS , WARNINGS and OVERDOSAGE ] . The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the dose.

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors [see WARNINGS ] .

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].