KLOR-CON M

INDICATIONS AND USAGE 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, 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 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 to 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 Klor-Con ® M10 tablet provides 750 mg of potassium chloride equivalent to 10 mEq of potassium. Each Klor-Con ® M15 tablet provides 1125 mg of potassium chloride equivalent to 15 mEq of potassium. Each Klor-Con ® M20 tablet provides 1500 mg of potassium chloride equivalent to 20 mEq of potassium. Klor-Con M 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 is not recommended.

CONTRAINDICATIONS 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 ]. Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of potassium chloride [see PRECAUTIONS: Information for Patients and DOSAGE AND ADMINISTRATION ]. All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

ADVERSE REACTIONS One of the most severe adverse effects is hyperkalemia [see CONTRAINDICATIONS , WARNINGS and OVERDOSAGE ]. There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation [see CONTRAINDICATIONS and WARNINGS ]. 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 amount taken at one time.

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

DESCRIPTION Klor-Con ® M10 (potassium chloride extended-release tablets, USP) is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Klor-Con ® M15 (potassium chloride extended-release tablets, USP) is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,125 mg of microencapsulated potassium chloride, USP equivalent to 15 mEq of potassium in a tablet. Klor-Con ® M20 (potassium chloride extended-release tablets, USP) is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1,500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Klor-Con ® M is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Klor-Con ® M is a tablet formulation (not enteric-coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Klor-Con ® M begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride, USP. Inactive Ingredients : croscarmellose sodium, ethylcellulose and microcrystalline cellulose.

OVERDOSAGE The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result [see CONTRAINDICATIONS and WARNINGS ]. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 to 12 mEq/L). Treatment measures for hyperkalemia include the following: Patients should be closely monitored for arrhythmias and electrolyte changes. 1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others. 2. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. 3. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. 4. Correction of acidosis, if present, with intravenous sodium bicarbonate. 5. Use of exchange resins, hemodialysis, or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended-release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

HOW SUPPLIED Klor-Con ® M10 Extended-release Tablets, contains 750 mg of potassium chloride (equivalent to 10 mEq of potassium) are white, oblong tablets and imprinted "KC M10". They are supplied as follows: Bottles of 90 tablets NDC 0245-5317-90 Bottles of 100 tablets NDC 0245-5317-11 Bottles of 1,000 tablets NDC 0245-5317-10 Unit-dose cartons of 100 tablets NDC 0245-5317-01 Klor-Con ® M15 Extended-release Tablets, contains 1,125 mg of potassium chloride (equivalent to 15 mEq of potassium) are white, oblong tablets and imprinted "M 15" and scored for flexibility of dosing. They are supplied as follows: Bottles of 100 tablets NDC 0245-5318-11 Unit-dose cartons of 100 tablets NDC 0245-5318-01 Klor-Con ® M20 Extended-release Tablets, contains 1,500 mg of potassium chloride (equivalent to 20 mEq of potassium) are white, oblong tablets and imprinted "KC M20" and scored for flexibility of dosing. They are supplied as follows: Bottles of 90 tablets NDC 0245-5319-90 Bottles of 100 tablets NDC 0245-5319-11 Bottles of 500 tablets NDC 0245-5319-15 Bottles of 1,000 tablets NDC 0245-5319-10 Unit-dose cartons of 100 tablets NDC 0245-5319-01 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]. Keep tightly closed.