CLASSES

Alkalinizing Agents
Carbohydrate IV Solutions and Additives, more than 10%
Electrolytes with Carbohydrate Solutions
Potassium Supplements
Sodium Chloride Solutions with Potassium
Supplemental Dietary Agents

DEA CLASS

OTC, Rx

DESCRIPTION

Potassium is primary intracellular cation
Dietary supplement used to maintain potassium balance (i.e., hypokalemia prevention)
Guidelines recommend that serum potassium concentrations of at least 4 mEq/L be achieved and maintained in patients with hypertension, heart failure, and cardiac arrhythmias

COMMON BRAND NAMES

Cena K, Effer-K, Epiklor, K Plus, K Plus Care ET, K-Dur, K-Lor, K-Lyte, K-Sol, K-Tab, K-Vescent, Kaon-CL, Kay Ciel, Klor-Con, Klor-Con EF, Klor-Con M10, Klor-Con M15, Klor-Con M20, Klotrix, Micro-K, Micro-K Extencaps, Slow-K

HOW SUPPLIED

Cena K/Kaon-CL/Kay Ciel/K-Sol/Potassium Chloride Oral Sol: 15mL, 20mEq, 40mEq
Effer-K/K Plus Care ET/Klor-Con EF/K-Lyte/K-Vescent/Potassium Bicarbonate/Potassium Bicarbonate, Potassium Chloride Oral Tab Effrv: 25mEq, 10-0.84g, 20-1.68g, 25-1.5g
Epiklor/K Plus/Kay Ciel/K-Lor/Klor-Con/K-Sol/Potassium Chloride Oral Pwd F/Recon: 20mEq, 25mEq
K-Dur/Klor-Con/Klor-Con M10/Klor-Con M15/Klor-Con M20/Klotrix/K-Tab/Potassium Chloride/Slow-K Oral Tab ER: 8mEq, 10mEq, 15mEq, 20mEq
Klor-Con/Micro-K/Micro-K Extencaps/Potassium Chloride Oral Cap ER: 8mEq, 10mEq
Potassium Acetate/Potassium Chloride/Potassium Chloride, Dextrose/Potassium Chloride, Dextrose, Sodium Chloride/Potassium Chloride, Sodium Chloride Intravenous Inj Sol: 1mL, 2mEq, 4mEq, 10mEq, 20mEq, 30mEq, 40mEq, 50mL, 100mL, 10-5-0.225%, 10-5-0.45%, 20-0.45%, 20-0.9%, 20-5%, 20-5-0.2%, 20-5-0.225%, 20-5-0.3%, 20-5-0.45%, 20-5-0.9%, 30-5%, 30-5-0.225%, 30-5-0.45%, 40-0.9%, 40-5%, 40-5-0.225%, 40-5-0.45%, 40-5-0.9%
Potassium Oral Tab: 83mg, 99mg

DOSAGE & INDICATIONS

MAXIMUM DOSAGE

Tolerable upper limit not established; usual Max dose as a dietary supplement is 2 tablets/day PO.

Tolerable upper limit not established; usual Max dose as a dietary supplement is 2 tablets/day PO.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

DOSING CONSIDERATIONS

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available. Monitor serum potassium concentrations and renal function carefully to avoid development of hyperkalemia.

ADMINISTRATION

STORAGE

Generic:
- Store in a cool, dry place
Cena K :
- Protect from light
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Effer-K:
- Store at room temperature (between 59 to 86 degrees F)
Epiklor:
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
K Plus:
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
K Plus Care ET :
- Store at room temperature (between 59 to 86 degrees F)
Kaon-CL:
- Protect from freezing
- Store at controlled room temperature (between 68 and 77 degrees F)
Kay Ciel :
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
K-Dur:
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
K-Lor:
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Klor-Con:
- Store at controlled room temperature (between 68 and 77 degrees F)
Klor-Con EF:
- Store at room temperature (between 59 to 86 degrees F)
Klor-Con M10:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Klor-Con M15:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Klor-Con M20:
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
Klotrix:
- Store at controlled room temperature (between 68 and 77 degrees F)
K-Lyte:
- Store at room temperature (between 59 to 86 degrees F)
K-Sol :
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
K-Tab:
- Store at controlled room temperature (between 68 and 77 degrees F)
K-Vescent :
- Store at room temperature (between 59 to 86 degrees F)
Micro-K:
- Store at controlled room temperature (between 68 and 77 degrees F)
Micro-K Extencaps:
- Store at controlled room temperature (between 68 and 77 degrees F)
Slow-K:
- Protect from light
- Protect from moisture
- Store at controlled room temperature (between 68 and 77 degrees F)

CONTRAINDICATIONS / PRECAUTIONS

Potassium gluconate is contraindicated in patients with known hypersensitivity to any potassium formulation.

Potassium gluconate is contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Due to the risk of developing hyperkalemia, potassium supplementation should be used with caution in patients with adrenal insufficiency (untreated Addison's disease); acute dehydration; systemic metabolic acidosis such as diabetic ketoacidosis; in patients receiving salt substitutes, potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene), ACE inhibitors, angiotensin II antagonists, cyclosporine, or tacrolimus; or in patients with renal disease, renal failure, or renal impairment. Potassium supplements should also be used cautiously in patients with severe burns because these patients are prone to hyperkalemia secondary to tissue breakdown and renal insufficiency. Serum potassium concentrations and renal function should be monitored closely in patients at risk for hyperkalemia. Because geriatric patients are more likely to have decreased renal function, potassium gluconate should be dosed cautiously based on an assessment of renal function and therapeutic goals.

Monitor patients with cardiac arrhythmias (e.g., atrial fibrillation, atrial flutter, digitalis toxicity (except due to documented hypokalemia), and ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia), including patients receiving digoxin or other antiarrhythmic therapy, closely during administration of potassium supplements. Patients with other cardiac disorders, such as heart failure or AV block, also require close monitoring when receiving potassium supplements. Clinical practice guidelines recommend that serum potassium concentrations of at least 4 mEq/L be achieved and maintained in patients with hypertension, heart failure, and cardiac arrhythmias to minimize complications of potassium depletion. In addition, potassium supplementation is recommended for patients at risk for developing hypokalemia and associated complications. Potassium supplementation is specifically recommended for patients with potential for diuretic-induced potassium loss (e.g., receiving thiazide or loop diuretics), patients with high sodium intake (unwilling to reduce salt intake), and patients with reduced GI intake (e.g., GI disturbances, laxative abuse).

There are no adequate, well controlled studies with potassium supplements in pregnant women and animal reproduction studies have not been conducted. Therefore, it is unknown whether potassium gluconate can cause fetal harm when administered during pregnancy. Use potassium gluconate during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Although data are limited, potassium supplements appear to be safe and effective to use during breast-feeding to help meet maternal nutritional requirements. The normal potassium ion content of human milk is about 13 mEq/L. Because exogenous potassium becomes part of the body potassium pool, so long as body potassium is not excessive, potassium supplementation should have little or no effect on the concentration in human milk.

Use potassium supplements with caution in patients with potassium-aggravated skeletal muscle channelopathy, such as hyperkalemic periodic paralysis, paramyotonia congenita, and potassium-aggravated myotonia/paramyotonia.

ADVERSE REACTIONS

hyperkalemia / Delayed / Incidence not known
AV block / Early / Incidence not known
bradycardia / Rapid / Incidence not known
muscle paralysis / Delayed / Incidence not known
ventricular fibrillation / Early / Incidence not known
asystole / Rapid / Incidence not known
arrhythmia exacerbation / Early / Incidence not known
cardiac arrest / Early / Incidence not known

hypotension / Rapid / Incidence not known
confusion / Early / Incidence not known
dyspnea / Early / Incidence not known

hyporeflexia / Delayed / Incidence not known
weakness / Early / Incidence not known
fatigue / Early / Incidence not known
anxiety / Delayed / Incidence not known
paresthesias / Delayed / Incidence not known
nausea / Early / Incidence not known
vomiting / Early / Incidence not known
flatulence / Early / Incidence not known
diarrhea / Early / Incidence not known
abdominal pain / Early / Incidence not known
rash / Early / Incidence not known

DRUG INTERACTIONS

Monograph content under development

PREGNANCY AND LACTATION

There are no adequate, well controlled studies with potassium supplements in pregnant women and animal reproduction studies have not been conducted. Therefore, it is unknown whether potassium gluconate can cause fetal harm when administered during pregnancy. Use potassium gluconate during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Although data are limited, potassium supplements appear to be safe and effective to use during breast-feeding to help meet maternal nutritional requirements. The normal potassium ion content of human milk is about 13 mEq/L. Because exogenous potassium becomes part of the body potassium pool, so long as body potassium is not excessive, potassium supplementation should have little or no effect on the concentration in human milk.

MECHANISM OF ACTION

Potassium is actively transported into cells through a process facilitated by dextrose, insulin, and oxygen. Transport maintains a high potassium gradient across cell membranes, thus playing a vital role in electrical excitability of nerves and muscle. Relatively high intracellular potassium concentrations leads to passive diffusion out of the cell. The membrane gradient is responsible for the resting transmembrane electric potential, primarily determined by the diffusion of potassium out of the cell. Membrane depolarization will occur only when a current is applied to the nerve that exceeds the outward potassium current. This is usually accomplished by sodium rushing into the cell by fast inward channels, causing the action or 'spike' potential. Repolarization is partially but quickly attained by potassium flowing out of the cell through its own channel.
Hydrogen ions are also in higher concentration inside cells. When the extracellular hydrogen ion concentration is increased, as occurs in acidosis, potassium shifts to the extracellular environment; when it is decreased, potassium ions move into the cells. Hypo- or hyperkalemia can initiate changes in concentration of other ions. In the former state, when potassium becomes depleted, as the ion leaves the cell it is exchanged with extracellular sodium and hydrogen ions to maintain electroneutrality. The redistribution of hydrogen ions causes intracellular acidosis and extracellular alkalosis. The opposite happens in hyperkalemia.
Within or near the normal range of potassium balance, the ion plays a part in regulating renal synthesis of ammonia and in the pH of urine. A decrease in dietary intake of potassium stimulates renal synthesis of ammonia and increases urinary pH slightly by diminishing net acid secretion. If potassium loss is low, metabolic acidosis results. Greater potassium loss can cause systemic metabolic alkalosis and intracellular acidosis. Tubular secretion of potassium is inhibited by acidemia and stimulated by alkalemia.

PHARMACOKINETICS

Potassium gluconate is administered orally. Potassium first enters the extracellular fluid and is then actively transported into cells. Skeletal muscle accounts for the bulk of the intracellular store of potassium. Renal excretion of potassium normally is equal to the amount being absorbed in the diet. Potassium is freely filtered at the glomerulus and almost completely reabsorbed in the proximal tubule. Tubular secretion occurs in the late distal convoluted tubule and collecting duct, and accounts for the potassium excreted in the urine, which is about 10% of the amount filtered. Fecal elimination of potassium is minimal and plays no significant role in potassium homeostasis.
 
Affected cytochrome P450 isoenzymes: none