The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Potassium Chloride (NDC 0121-4948). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 1 indications and usage, 3 dosage forms and strengths, 4 contraindications, 5.1 gastrointestinal irritation, 6 adverse reactions, 7.1 potassium-sparing diuretics, 7.2 renin-angiotensin-aldosterone system inhibitors, 7.3 nonsteroidal anti-inflammatory drugs (nsaids), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Oral Solution 10%: 1.3 mEq potassium per mL.
Oral Solution 20%: 2.6 mEq potassium per mL.
Potassium chloride is contraindicated in patients on potassium sparing diuretics.
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)] .
The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.
Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use.
Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy.
NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.
Risk Summary
The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as Potassium Chloride becomes part of the body potassium pool, as 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.
The safety and effectiveness of Potassium Chloride have been demonstrated in children with diarrhea and malnutrition from birth to 16 years.
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.
Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. [see Clinical Pharmacology (12.3)].
Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on ACE inhibitors, ARBs, or nonsteroidal anti-inflammatory drugs should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia. The serum potassium level should be monitored frequently. Renal function should be assessed periodically.
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 (6.5-8.0 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 (9-12 mEq/L).
Treatment measures for hyperkalemia include the following:
In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.
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.
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.
Potassium Chloride Oral Solution, USP 10% (20 mEq/15 mL) is an orange flavored, clear orange-colored solution available as follows:
NDC 0121-0948-16: 16 fl oz (473 mL) Bottle.
NDC 0121-4948-15: 15 mL unit dose cup. Case contains 30 unit-dose cups of 15 mL (NDC 0121-4948-94), packaged in 3 trays of 10 unit-dose cups each, 40 unit-dose cups of 15 mL (NDC 0121-4948-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 15 mL (NDC 0121-4948-50), packaged in 5 trays of 10 unit-dose cups each, 80 unit-dose cups of 15 mL (NDC 0121-4948-80), packaged in 8 trays of 10 unit-dose cups each and 100 unit-dose cups of 15 mL (NDC 0121-4948-00), packaged in 10 trays of 10 unit-dose cups each.
NDC 0121-1896-30: 30 mL unit dose cup. Case contains 40 unit-dose cups of 30 mL (NDC 0121-1896-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 30 mL (NDC 0121-1896-50), packaged in 5 trays of 10 unit-dose cups each and 100 unit-dose cups of 30 mL (NDC 0121-1896-00), packaged in 10 trays of 10 unit-dose cups each.
Potassium Chloride Oral Solution, USP 20% (40 mEq/15 mL) is an orange flavored, clear orange-colored, solution available as follows:
NDC 0121-2847-16: 16 fl oz (473 mL) Bottle.
NDC 0121-2847-15: 15 mL unit dose cup. Case contains 30 unit-dose cups of 15 mL (NDC 0121-2847-94), packaged in 3 trays of 10 unit-dose cups each, 40 unit-dose cups of 15 mL (NDC 0121-2847-40), packaged in 4 trays of 10 unit-dose cups each, 50 unit-dose cups of 15 mL (NDC 0121-2847-50), packaged in 5 trays of 10 unit-dose cups each, 80 unit-dose cups of 15 mL (NDC 0121-2847-80), packaged in 8 trays of 10 unit-dose cups each and 100 unit-dose cups of 15 mL (NDC 0121-2847-00), packaged in 10 trays of 10 unit-dose cups each.
NDC 0121-0948-16
Potassium Chloride Oral Solution, USP 10%
20 mEq / 15 mL
DILUTE PRIOR TO ADMINISTRATION
Rx ONLY
16 fl oz (473 mL)
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
X0948160422 R04/22
Principal Display Panel (16 fl oz (473 mL))
NDC 0121-2847-16
Potassium Chloride Oral Solution, USP 20%
40 mEq / 15 mL
DILUTE PRIOR TO ADMINISTRATION
Rx ONLY
16 fl oz (473 mL)
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
X0948160422 R04/22
Principal Display Panel (16 fl oz (473 mL))
Delivers 15 mL
NDC 0121-4948-15
Potassium Chloride Oral Solution, USP 10%
20 mEq per 15 mL
DILUTE PRIOR TO ADMINISTRATION
Package Not Child-Resistant
Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
Principal Display Panel (15 mL Cup Label)
Delivers 15 mL
NDC 0121-2847-15
Potassium Chloride Oral Solution, USP 20%
40 mEq per 15 mL
DILUTE PRIOR TO ADMINISTRATION
Package Not Child-Resistant
Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
Principal Display Panel (15 mL Cup Label)
Delivers 30 mL
NDC 0121-1896-30
Potassium Chloride Oral Solution, USP 10%
40 mEq per 30 mL
DILUTE PRIOR TO ADMINISTRATION
Package Not Child-Resistant
Rx ONLY
PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
Principal Display Panel (30 mL Cup Label)
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