2.1 Administration and Monitoring

2.2 Adult Dosing

2.3 Pediatric Dosing

5.1 Gastrointestinal Irritation

May cause gastrointestinal irritation if administered undiluted. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1)].

7.1 Potassium-Sparing Diuretics

Use with potassium-sparing diuretic can produce severe hyperkalemia. Avoid concomitant use.

7.2 Angiotensin-Converting Enzyme Inhibitors

Use with angiotensin converting enzyme (ACE) inhibitors produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

7.3 Angiotensin Receptor Blockers

Use with angiotensin receptor blockers (ARBs) produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ARBs only with close monitoring.

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with potassium chloride. 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.

8.2 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.

8.3 Pediatric Use

The safety and effectiveness of potassium chloride have been demonstrated in children with diarrhea and malnutrition from birth to18 years.

8.4 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.

10.1 Symptoms

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 potentially fatal hyperkalemia can result.

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 to12 mEq/L).

10.2 Treatment

Treatment measures for hyperkalemia include the following:

1. Monitor closely for arrhythmias and electrolyte changes.
2. Eliminate 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.
3. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
4. Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1000 mL.
5. Correct acidosis, if present, with intravenous sodium bicarbonate.
6. Use exchange resins, hemodialysis, or peritoneal dialysis.

In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

12.1 Mechanism of Action

The potassium ion (K+) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

12.3 Pharmacokinetics

Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral solution were higher during the first few hours after dosing relative to modified release KCl products. The bioavailability of potassium, as measured by the cumulative urinary excretion of K+ over a 24 hour post dose period, is similar for KCl solution and modified release products.

Storage

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

PROTECT from LIGHT.

POTASSIUM CHLORIDE ORAL SOLUTION, USP, 10% and 20%

Packaged by:

Safecor Health, LLC

4060 Business Park Drive

Columbus, OH 43204

Manufactured by:

Apotex Inc.

Toronto, Ontario

Canada M9L 1T9

Manufactured for:

Apotex Corp.

Weston, Florida

USA 33326

Rev: 03/2019 PN5644