General
The diagnosis of potassium depletion is ordinarily made by
demonstrating hypokalemia in a patient with a clinical history suggesting some
cause for potassium depletion. In interpreting the serum potassium level, the
physician should bear in mind that acute alkalosis per
se can produce hypokalemia in the absence of a deficit in total body
potassium, while acute acidosis per se can increase
the serum potassium concentration into the normal range even in the presence of
a reduced total body potassium. The treatment of potassium depletion,
particularly in the presence of cardiac disease, renal disease, or acidosis,
requires careful attention to acid-base balance and appropriate monitoring of
serum electrolytes, the electrocardiogram, and the clinical status of the
patient.
Information for Patients
Physicians should consider reminding the patient of the
following:
To take each dose with meals and with a full glass of water or other
suitable liquid. To take each dose without crushing, chewing, or sucking the capsules. To take this medicine following the frequency and amount prescribed by the
physician. This is especially important if the patient is also taking diuretics
and/or digitalis preparations. To check with the physician if there is trouble swallowing capsules or if
the capsules seem to stick in the throat. To check with the physician at once if tarry stools or other evidence of
gastrointestinal bleeding is noticed.Laboratory Tests
Regular serum potassium determinations are recommended,
especially in patients with renal insufficiency or diabetic nephropathy.
When blood is drawn for analysis of plasma potassium it is important to
recognize that artifactual elevations can occur after improper venipuncture
technique or as a result of in vitro hemolysis of the
sample.
Drug Interactions
Potassium-sparing diuretics, 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.
PregnancyTeratogenic Effects: Category C
Animal reproduction studies have not been conducted with
Potassium chloride extended-release capsules. 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
supplementation should have little or no effect on the level in human
milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use
Clinical studies of Potassium chloride extended-release capsules
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 identified 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.
