POTASSIUM CHLORIDE- potassium chloride_tablet, film coated, extended release

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 potassium chloride in potassium chloride extended-release tablets are completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the potassium chloride extended-release tablets are compared to that of a true solution the extent of absorption is similar. Specific Populations.

Potassium chloride extended-release tablets are 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 is insufficient. Potassium chloride extended-release tablets are a potassium salt, 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 is insufficient.

Monitor serum potassium and adjust dosages accordingly (2. 1) If serum potassium is less than 2. 5 mEq/L, use intravenous potassium instead of oral supplementation (2. 1) Take with meals and with a glass of water or other liquid. Swallow tablets whole without crushing, chewing or sucking. 1) Treatment of hypokalemia (2. 2) Prevention of hypokalemia (2. 2) If serum potassium concentration is less than 2. 5 mEq/L, use intravenous potassium instead of oral supplementation. [see Warnings and Precautions (5. 1) 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.

The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www. gov/medwatch.

Potassium chloride is contraindicated in patients on triamterene and amiloride. Concomitant use with triamterene and amiloride (4).

Cirrhosis: Initiate therapy at the low end of the dosing range (8. 6) Renal Impairment: Initiate therapy at the low end of the dosing range (8. 7) Risk Summary Risk Summary 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 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. Based on publish literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. 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 RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions (7.

Triamterene and amiloride: Concomitant use is contraindicated (7. 1) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia (7. 2) Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7. 3) Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [see Contraindications (4) 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 on concomitant RAAS inhibitors. NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and imparing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

OVERDOSAGE
The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see CONTRAINDICATIONS WARNINGS Treatment measures for hyperkalemia include the following: Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. Correction of acidosis, if present, with intravenous sodium bicarbonate. Use of exchange resins, hemodialysis or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
NON CLINICAL TOXICOLOGY
Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

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