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Klor-Con ER

[potassium chloride]


Warnings & Precautions
WARNINGS

Hyperkalemia (see OVERDOSAGE): In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asympto-matic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

Interaction with Potassium-sparing Diuretics

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Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e. g., spironolactone, triamterene or amiloride), since the simultaneous administra-tion of these agents can produce severe hyperkalemia.

Interaction with Angiotensin Converting Enzyme Inhibitors

Angiotensin converting enzyme (ACE) inhibitors (e. g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of potassium chloride can produce ulcerative and/ or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are asso-ciated with an increased frequency of small bowel lesions (40 -50 per 100,000 patient years) compared to extended-release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Klor-Con ® (Potassium Chloride Extended-release Tablets, USP) are wax matrix tablets formulated to provide an extended rate of release of potassium chloride and thus to minimize the possibility of high local con-centration of potassium near the gastrointestinal wall.

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