POTASSIUM CHLORIDE

Potassium chloride extended-release capsules USP, 10 mEq are an oral dosage form of microencapsulated potassium chloride containing 750 mg of potassium chloride, USP equivalent to 10 mEq of potassium. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP occurs as a white granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The inactive ingredients are, ethylcellulose, FD&C Blue #1, FD&C Red # 40, gelatin, sodium lauryl sulfate, titanium oxide and triethyl citrate.

Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

2.1 Administration and Monitoring If serum potassium concentration is < 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring 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. Administration Take with meals and with a full glass of water or other liquid. Do not take on an empty stomach because of the potential for gastric irritation [see Warnings and Precautions (5.1)]. Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of water or juice to ensure complete swallowing of the microcapsules. Do not added to hot foods. Any microcapsule/food mixture should be used immediately and not stored for future use. 2.2 Adult 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. Treatment of hypokalemia: Typical dose range is 40 to 100 mEq per day. Maintenance or Prophylaxis: Typical dose is 20 mEq per day. 2.3 Pediatric Dosing Pediatric patients aged birth to 16 years old: Dosage must be adjusted to the individual needs of each patient. Do not exceed as a single-dose 1 mEq/kg or 20 mEq, whichever is lower. Treatment of hypokalemia: The recommended initial dose is 2 to 4 mEq/kg/day in divided doses. If deficits are severe or ongoing losses are great, consider intravenous therapy. Maintenance or Prophylaxis: Typical dose is 1 mEq/kg/day.

Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene.

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 to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/ discomfort, and diarrhea. There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including, obstruction, bleeding, ulceration, and perforation. Skin rash has been reported rarely. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7.1 Amiloride and Triamterene Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [see Contraindications (4)]. 7.2 Renin-Angiotensin-Aldosterone Inhibitors Drugs that inhibit the renin-angiotensin-aldosternone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produces potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients taking drugs that inhibit RAAS. 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients taking NSAIDs.