GLUPOTAS

Potassium gluconate is a salt of

Potassium cation and is classified as a food additive by the FDA 7.

It is also used as a potassium supplement 10.

Potassium is an essential nutrient.

It is the most abundant cation in the intracellular fluid, where it plays a key role in maintaining cell function 1.

In dietary supplements, potassium is often present as potassium chloride, but many other forms—including potassium citrate, phosphate, aspartate, bicarbonate, and gluconate —are also used 5.

Potassium gluconate is believed to be more palatable and non-acidifying than potassium chloride (KCl) 11.

Because of potassium's wide-ranging roles in the body, low intakes can increase the risk of illness 8.

Potassium supplements are indicated to prevent hypokalemia in patients who would be at particular risk if hypokalemia were to develop (e.g., digitalis treated patients with significant cardiac arrhythmias).

Potassium deficiency occurs when the rate of loss through renal excretion and/or loss from the gastrointestinal tract is higher than the rate of potassium intake.

In addition to serving as a preventative supplement, potassium gluconate also serves as a treatment for decreased potassium levels 8, 4, 10.

Potassium is an essential nutrient.

It is the most abundant cation in intracellular fluid, where it plays a key role in maintaining cell function, especially in excitable cells such as skeletal muscles, the heart, and nerves 3.

Increases in interstitial potassium play an important role in eliciting rapid vasodilation, allowing for blood flow to increase in exercising muscle 13.

Potassium is the most abundant cation (approximately 150-160 mEq per liter) within human cells.

Intracellular sodium content is relatively low.

In the extracellular fluid, sodium predominates and the potassium content is low (3.5-5 mEq per liter).

A membrane-bound enzyme, sodium-potassium–activated adenosinetriphosphatase (Na +K +ATPase), actively transports or pumps sodium out and potassium into cells to maintain the concentration gradients.

The intracellular to extracellular potassium gradients are necessary for nerve impulse signaling in such specialized tissues as the heart, brain, and skeletal muscle, and for the maintenance of physiologic renal function and maintenance of acid-base balance.

High intracellular potassium concentrations are necessary for numerous cellular metabolic processes 8.

K+ serves as a reservoir to limit the fall in extracellular potassium concentrations occurring under pathologic conditions with loss of potassium from the body 13.

Potassium is rapidly and well absorbed.

A 2016 dose-response trial found that humans absorb about 94% of potassium gluconate in supplements, and this absorption rate is similar to that of potassium from potatoes 2.

Distribution is largely intracellular, but it is the intravascular concentration that is primarily responsible for toxicity 6.

90% of potassium is eliminated via the kidneys.

A small amount is eliminated in feces and sweat 6.

Potassium is freely filtered by the glomerulus in the kidney.

The majority of filtered potassium is reabsorbed in the proximal tubule and loop of Henle.

Less than 10% of the filtered load reaches the distal nephron.

In the proximal tubule of the nephron, potassium absorption is mainly passive and proportional to Na+ and water.

K+ reabsorption in the thick ascending limb of Henle occurs through both transcellular and paracellular pathways.

The transcellular component is regulated by potassium transport on the apical membrane Na+-K+-2Cl− cotransporter.

The secretion of potassium begins in the early distal convoluted tubule of the nephron and progressively increases along the distal nephron into the cortical collecting duct.

Most urinary

K+ can be accounted for by electrogenic K+ secretion mediated by principal cells in the initial collecting duct and the cortical collecting duct.

An electroneutral

K+ and Cl− cotransport mechanism is also present on the apical surface of the distal nephron.

Under conditions of potassium deficiency, reabsorption of the cation occurs in the collecting duct.

This process is regulated by the upregulation in the apically located H+-K+-ATPase on α-intercalated cells 13.

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Acute oral toxicity (LD50): 9100 mg/kg in the mouse MSDS Toxicity from overdose is rare but may result from intentional ingestion of potassium.

Iatrogenic overdoses may occur 6.

Local irritation after ingestion causes

GI upset.

Severe hyperkalemia after large

Intravenous or oral overdoses causes muscular dysfunction including weakness, paralysis, cardiac dysrhythmias, and rarely death 6.

Mild to moderate toxicity

Nausea, vomiting, diarrhea, paresthesias, and muscle cramps are common.

Rarely, gastrointestinal bleed may occur.

Severe toxicity

In severe toxicity, muscular weakness progressing to paralysis may occur.

Cardiac arrhythmia often occur at concentrations greater than 8 mEq/L and death from cardiac arrest at concentrations of 9-12 mEq/L or higher.

ECG findings occur in the following order: peaked T waves, QRS complex blends into the T wave, PR interval prolongation, P wave is lost and ST segments depress, merging S and T waves, and finally, sine waves.

The presence of the sine wave is a near terminal event, signaling that hemodynamic collapse and cardiac arrest are near.

As serum hyperkalemia is corrected towards normal concentrations, the ECG changes resolve in reverse order 6.

Potassium chloride is contraindicated in patients on triamterene and amiloride.

Concomitant use with triamterene and amiloride.

Monitor serum potassium and adjust dosages accordingly If serum potassium is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation Take with meals and with a glass of water or other liquid.

Swallow tablets whole without crushing, chewing or sucking.

Treatment of hypokalemia

Doses range from to 100 mEq/day in divided doses.

Limit doses to 40 mEq per dose.

Prevention of hypokalemia

Typical dose is 20 mEq per day. 2.1 Administration and Monitoring If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation.

Monitor serum potassium and adjust dosages accordingly.

Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.

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.

Take potassium chloride extended-release tablets with meals and with a glass of water or other liquid.

Do not take potassium chloride extended-release tablets on an empty stomach because of its potential for gastric irritation.

Swallow tablets whole without crushing, chewing or sucking. 2.2 Dosing Dosage must be adjusted to the individual needs of each patient.

Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single dose.

Typical dose range is to 100 mEq per day. Maintenance or Prophylaxis: Typical dose range is 20 mEq per day.

Tablets, USP contain 600 mg or 750 mg of Potassium Chloride, USP (equivalent to 8 mEq and 10 mEq respectively), and are provided as extended release tablets.

Table 1: How Supplied Dose Shape Color Debossment Bottle of 100 tablets Bottle of 500 tablets Bottle of 1000 tablets 600 mg (8 mEq) Round White to off-white “YH” and “106” on one side, and “8” on the other side 42806-422-01 42806-422-05 42806-422-10 750 mg (10 mEq) Round White to off-white “YH” and “105” on one side, and “10” on the other side 42806-423-01 42806-423-05 42806-423-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) Protect from light and moisture.

Dispense in a tight container as defined in the USP with a child-resistant closure.

There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction 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 to 4% and to 20%, respectively.

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.

Safety and effectiveness in the pediatric population have not been established.

Clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 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.