The following Structured Product Label (SPL) was submitted to the FDA by Saptalis Pharmaceuticals, Llc for the product Potassium Chloride (NDC 71656-021). 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, 2.1 administration and monitoring, 2.2 adult dosing, 2.3 pediatric dosing, 3 dosage forms and strengths, 4 contraindications, 5.1 gastrointestinal irritation, 6 adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Potassium chloride oral solution 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.
Monitoring
Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis.
The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate.
Administration
Dilute the potassium chloride oral solution with at least 4 ounces of cold water [see Warnings and Precautions (5.1)].
Take with meals or immediately after eating.
If serum potassium concentration is < 2.5 mEq/L, use intravenous potassium instead of oral supplementation.
Treatment of hypokalemia
Daily dose ranges from 40 to 100 mEq. Give in 2 to 5 divided doses; limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24-hour period.
Maintenance or Prophylaxis
Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels.
Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain.
Treatment of hypokalemia
Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy.
Maintenance or Prophylaxis
Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.
Oral Solution 10%: 1.3 mEq potassium per mL.
Oral Solution 20%: 2.6 mEq potassium per mL.
Potassium chloride oral solution 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.
There are no human data related to use of potassium chloride during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.
The background risk for major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
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 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 to 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, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55.
Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.
Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.
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 is a clear orange liquid with citrus aroma, available in two strengths and supplied as Unit Dose Cups for institutional use only, as follows:
10%: 20 mEq/15 mL oral solution
NDC# 71656-021-16 Bottle with child-resistant cap of 473 mL
NDC# 71656-021-50 15 mL (20 mEq) fill, case of 5 trays x 10s
NDC# 71656-021-01 15 mL (20 mEq) fill, case of 10 trays x 10s
NDC# 71656-021-51 30 mL (40 mEq) fill, case of 5 trays x 10s
NDC# 71656-021-02 30 mL (40 mEq) fill, case of 10 trays x 10s
20%: 40 mEq/15 mL oral solution
NDC# 71656-022-16 Bottle with child-resistant cap of 473 mL
NDC# 71656-022-50 15 mL (40 mEq) fill, case of 5 trays x 10s
NDC# 71656-022-01 15 mL (40 mEq) fill, case of 10 trays x 10s
Storage
Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP. Keep tightly closed.
PROTECT from LIGHT and FREEZING.
Rx only
Distributed by:
Saptalis Pharmaceuticals, LLC
Hauppauge, NY 11788
PPM-0053
02/23-R1
NDC 71656-021-16
Potassium Chloride Oral Solution USP, 10%
20 mEq per 15 mL
DILUTE PRIOR TO ADMINISTRATION
Rx only
473 mL
20 Meq Label (Image00001 V1) 
71656-021-15
Potassium Chloride Oral Solution USP, 10%
20 mEq/15 mL
DILUTE PRIOR TO ADMINISTRATION
Unit dose delivers 15 mL
Orange Flavor
20 Meq Label (Image00002 V1) 
NDC 71656-021-50
Potassium Chloride Oral Solution USP, 10%
20 mEq/15 mL per cup
Unit-dose delivers 15 mL
Orange Flovor
DILUTE PRIOR TO ADMINISTRATION
Rx only
5 Trays contain 50 Unit-dose Cups
20 Meq Label (Image00003 V1) 
NDC 71656-021-01
Potassium Chloride Oral Solution USP, 10%
20 mEq/15 mL per cup
Unit-dose delivers 15 mL
Orange Flovor
DILUTE PRIOR TO ADMINISTRATION
Rx only
10 Trays contain 100 Unit-dose Cups
20 Meq Label (Image00004 V1) 
71656-021-30
Potassium Chloride Oral Solution USP, 10%
40 mEq/30 mL
DILUTE PRIOR TO ADMINISTRATION
Unit dose delivers 30 mL
Orange Flavor
40 Meq Label (Image00005 V1) 
NDC 71656-021-51
Potassium Chloride Oral Solution USP, 10%
40 mEq/30 mL per cup
Unit-dose delivers 30 mL
Orange Flavor
DILUTE PRIOR TO ADMINISTRATION
Rx only
5 Trays contain 50 Unit-dose Cups
40 Meq Label (Image00006 V1) 
NDC 71656-021-02
Potassium Chloride Oral Solution USP, 10%
40 mEq/30 mL per cup
Unit-dose delivers 30 mL
Orange Flavor
DILUTE PRIOR TO ADMINISTRATION
Rx only
10 Trays contain 100 Unit-dose Cups
40 Meq Label (Image00007 V1) 
NDC 71656-022-16
Potassium Chloride Oral Solution USP, 20%
40 mEq per 15 mL
DILUTE PRIOR TO ADMINISTRATION
Rx only
473 mL
40 Meq Label (Image00008 V1) 
71656-022-15
Potassium Chloride Oral Solution USP, 20%
40 mEq/15 mL
DILUTE PRIOR TO ADMINISTRATION
Unit dose delivers 15 mL
Orange Flavor
40 Meq Label (Image00009 V1) 
NDC 71656-022-50
Potassium Chloride Oral Solution USP, 20%
40 mEq/15 mL per cup
Unit-dose delivers 15 mL
Orange Flavor
DILUTE PRIOR TO ADMINISTRATION
Rx only
5 Trays contains 50 Unit-dose Cups
40 Meq Carton (Image000010 V1) 
NDC 71656-022-01
Potassium Chloride Oral Solution USP, 20%
40 mEq/15 mL per cup
Unit-dose delivers 15 mL
Orange Flavor
DILUTE PRIOR TO ADMINISTRATION
10 Trays contains 100 Unit-dose Cups
40 Meq Carton (Image000011 V1) 
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