Label: POTASSIUM CHLORIDE tablet, extended release

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:

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To take each dose with meals and with a full glass of water or other liquid.

To take each dose without crushing, chewing or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they 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 one-half glass of water (4 fluid ounces).

2. Allow approximately 2 minutes for the tablet(s) to disintegrate.

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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 one fluid ounce of water, swirl, and consume immediately.

6. Then, add an additional one fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of potassium chloride extended-release tablets that is not taken immediately should be discarded. The use of other liquids for suspending potassium chloride extended-release tablets is not recommended.

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 at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

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Laboratory Tests: 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.

Pregnancy Category C: Animal reproduction studies have not been conducted with Potassium Chloride 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 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 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.

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