Klor-Con ER

[potassium chloride]

Side Effects

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One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS and OVERDOSAGE). There also have 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 diuretic, angiotensin converting enzyme inhibitors (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy

Pregnancy Category C.

Animal reproduction studies have not been con-ducted with Klor-Con ® Extended-release Tablets. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplemen-tation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Geriatric Use:

Clinical studies of Klor-Con ® Extended-release Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identi-fied differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.