For the use of a Registered Medical Practitioner, Hospital or Laboratory only.
1. Description
AddKay is a solid oral dosage form of potassium chloride and is an electrolyte replenisher. Its structural formula is KCl.
This formulation is intended to provide prolonged-release of potassium, minimise the likelihood of producing high, localised concentrations of potassium within the gastrointestinal tract. Each 750 mg of prolonged release Potassium Chloride tablet provides 10 mEq of potassium.
2. Composition
Each Prolonged Release Tablet Contains Potassium Chloride BP 750 mg
3. Dosage Form
Prolonged-release Tablet
4. Pharmacology
The potassium ion 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 normal adult plasma concentration is 3.5 to 5 mEq per litre. An active ion transport system maintains this gradient across the plasma membrane.
The usual dietary intake of potassium is 50 to 100 mEq per day. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops slowly as a consequence of prolonged therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, severe diarrhoea, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalaemia and metabolic alkalosis.
Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.
If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.
Pharmacodynamics
AddKay contains potassium chloride, an essential electrolyte that replenishes and maintains the body’s potassium stores in patients with hypokalaemia (low blood potassium levels). Potassium is the primary intracellular cation and plays a crucial role in maintaining the resting membrane potential of cells enabling normal nerve impulse transmission, muscle contraction, and cardiac electrical activity. By restoring normal potassium levels, AddKay helps improve neuromuscular function, supports normal heart rhythm, and contributes to acid–base balance and overall cellular function. When used as directed, it effectively prevents and treats potassium deficiency; however excessive potassium supplementation may lead to hyperkalaemia, particularly in patients with impaired kidney function or those taking medications that increase potassium levels.
Pharmacokinetics
Absorption: The prolonged-release tablet releases potassium gradually in the gastrointestinal tract, reducing the risk of high local potassium concentrations and stomach irritation. Potassium is absorbed mainly from the small intestine.
Distribution: About 98% of total body potassium is intracellular, especially in skeletal muscle. Normal serum potassium is maintained around 3.5–5.0 mEq/L.
Metabolism: Potassium is not metabolised. It functions as an essential electrolyte involved in nerve conduction, muscle contraction and cardiac electrical activity.
Elimination: Excess potassium is eliminated primarily by the kidneys, with small amounts lost in faeces and sweat. Renal function is the major determinant of potassium clearance.
5. Indications
- For the therapeutic use of patients with hypokalaemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalaemic familial periodic paralysis. If hypokalaemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalaemia.
- For the prevention of Hypokalaemia in patients who would be at particular risk if Hypokalaemia were to develop, e.g., digitalised patients or patients with significant cardiac arrhythmias.
6. Contraindications
Potassium supplements are contraindicated in patients with hyperkalaemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest.
All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis) or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.
7. Precautions
Warnings
The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.
Gastrointestinal Lesions: Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Potassium Chloride prolonged-release Tablets are formulated to provide an extended rate of release of potassium chloride and thus to minimise the possibility of high local concentration of potassium near the gastrointestinal wall.
Metabolic Acidosis: hypokalaemia in patients with metabolic acidosis should be treated with an alkalinising potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate or potassium gluconate.
General: The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalaemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should be aware that acute alkalosis per se can produce hypokalaemia in the absence of a deficit in total body potassium while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram and the clinical status of the patient.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with Potassium Chloride prolonged-release Tablets. It is unlikely that potassium supplementation that does not lead to hyperkalaemia would have an adverse effect on the fetus or would affect reproductive capacity.
Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq per litre. It is not known if Potassium Chloride prolonged-release tablets have an effect on this content. 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.
Paediatric Use: Safety and effectiveness in the paediatric population have not been established.
Geriatric Use: 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.
8. Drug Interactions
Potassium-sparing diuretic, angiotensin converting enzyme inhibitors.
Interaction with Potassium-sparing Diuretics: Hypokalaemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene or amiloride), since the simultaneous administration of these agents can produce severe hyperkalaemia.
Interaction with Angiotensin Converting Enzyme Inhibitors: Angiotensin converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.
9. Adverse Effects
One of the most severe adverse effects is hyperkalaemia. There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration and perforation. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhoea.
These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals or reducing the amount taken at one time. Skin rash has been reported rarely.
10. Dosage & Administration
Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalaemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.
Potassium Chloride Prolonged-Release Tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation.
11. Overdosage
No data available.
12. Storage
Store in a dry place at a temperature not exceeding 30°C. Protect from light. Keep the medicine out of reach of children.
13. Presentation
10 tablets in a strip and 5 strips in a monocarton.