Potassium chloride: uses, appearance and warnings

Potassium chloride for oral solution is 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 for oral solution is 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. (1)

Each pouch contains 1.5 g of potassium chloride, USP supplying 20 mEq of potassium and 20 mEq of chloride. Potassium chloride for oral solution, USP 20 mEq: Each pouch contains 1.5 g of Potassium Chloride providing potassium 20 mEq and chloride 20 mEq. (3)

Potassium chloride for oral solution USP, 20 mEq is supplied as a light pink to orange powder with an orange odor. It is available as follows: Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq Carton of 30 pouches: NDC 60219-1617-3 Carton of 100 pouches: NDC 60219-1617-8 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. PROTECT from LIGHT. Rx only Manufactured by: Amneal Pharmaceuticals Private Limited Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2022-00

Potassium chloride is contraindicated in patients on potassium sparing diuretics. Concomitant use with potassium sparing diuretics. (4)

Gastrointestinal Irritation: Dilute before use, take with meals. (5.1) 5.1 Gastrointestinal Irritation May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1) ] .

The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Potassium sparing diuretics: Avoid concomitant use. (7.1) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia. (7.2) Nonsteroidal Anti-Inflammatory Drugs: Monitor for hyperkalemia. (7.3) 7.1 Potassium-Sparing Diuretics Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use. 7.2 Renin-Angiotensin-Aldosterone System Inhibitors 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 receiving concomitant RAAS therapy. …