Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride for Oral Solution, is a light pink to orange color powder available in one strength as follows: 20 mEq NDC# 60687-855-99 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 60687-855-27 carton of 30 pouches NDC# 60687-855-92 carton of 100 pouches; Principal Display Panel – Carton – 20 mEq – 30 ct NDC 60687- 855 -27 Potassium Chloride for Oral Solution, USP 20 mEq Orange Flavored Rx Only Each pouch contains: Potassium Chloride……1.5 g 30 Single-Dose Pouches Usual Dose: See accompanying package insert for full prescribing information. Dosage must be adjusted to the individual needs of each patient. Directions: Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if pouch is torn. Distributed by: American Health Packaging Columbus, OH 43217 Issued date: 08/2024 Code No.: KR/DRUGS/KTK/25/415/98 1051002 20mEq_Potassium_Chloride_for_OS_Carton_30ct.jpg; Principal Display Panel – Carton – 20 mEq – 100 ct NDC 60687- 855 -92 Potassium Chloride for Oral Solution, USP 20 mEq Orange Flavored Rx Only 100 Single-Dose Pouches Each pouch contains: Potassium Chloride……1.5 g 100 Single-Dose Pouches Usual Dose: See accompanying package insert for full prescribing information. Dosage must be adjusted to the individual needs of each patient. Directions: Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if pouch is torn. Distributed by: American Health Packaging Columbus, OH 43217 Issued date: 08/2024 Code No.: KR/DRUGS/KTK/25/415/98 1051003 20mEq_Potassium_Chloride_for_OS_Carton_100ct.jpg; Principal Display Panel – Pouch – 20 mEq NDC 60687- 855 -99 Potassium Chloride for Oral Solution, USP 20 mEq Rx only Single Dose (1.5 g) Directions: Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq. Usual Dose: See prescribing information. Caution: Must be diluted. Keep out of reach of children. Do not use if pouch is torn. Distributed by: American Health Packaging Columbus, Ohio 43217 Issued date: 08/2024 Code No.: KR/DRUGS/KTK/25/415/98 1051004 20mEq_Potassium_Chloride_for_OS_Pouch.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride for Oral Solution, is a light pink to orange color powder available in one strength as follows: 20 mEq NDC# 60687-855-99 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 60687-855-27 carton of 30 pouches NDC# 60687-855-92 carton of 100 pouches
- Principal Display Panel – Carton – 20 mEq – 30 ct NDC 60687- 855 -27 Potassium Chloride for Oral Solution, USP 20 mEq Orange Flavored Rx Only Each pouch contains: Potassium Chloride……1.5 g 30 Single-Dose Pouches Usual Dose: See accompanying package insert for full prescribing information. Dosage must be adjusted to the individual needs of each patient. Directions: Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if pouch is torn. Distributed by: American Health Packaging Columbus, OH 43217 Issued date: 08/2024 Code No.: KR/DRUGS/KTK/25/415/98 1051002 20mEq_Potassium_Chloride_for_OS_Carton_30ct.jpg
- Principal Display Panel – Carton – 20 mEq – 100 ct NDC 60687- 855 -92 Potassium Chloride for Oral Solution, USP 20 mEq Orange Flavored Rx Only 100 Single-Dose Pouches Each pouch contains: Potassium Chloride……1.5 g 100 Single-Dose Pouches Usual Dose: See accompanying package insert for full prescribing information. Dosage must be adjusted to the individual needs of each patient. Directions: Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if pouch is torn. Distributed by: American Health Packaging Columbus, OH 43217 Issued date: 08/2024 Code No.: KR/DRUGS/KTK/25/415/98 1051003 20mEq_Potassium_Chloride_for_OS_Carton_100ct.jpg
- Principal Display Panel – Pouch – 20 mEq NDC 60687- 855 -99 Potassium Chloride for Oral Solution, USP 20 mEq Rx only Single Dose (1.5 g) Directions: Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq. Usual Dose: See prescribing information. Caution: Must be diluted. Keep out of reach of children. Do not use if pouch is torn. Distributed by: American Health Packaging Columbus, Ohio 43217 Issued date: 08/2024 Code No.: KR/DRUGS/KTK/25/415/98 1051004 20mEq_Potassium_Chloride_for_OS_Pouch.jpg
Overview
Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light pink to orange color powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.
Indications & Usage
Potassium Chloride 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 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 )
Dosage & Administration
Dilute prior to administration. ( 2.1 , 5.1 ) Monitor serum potassium and adjust dosage accordingly ( 2.2 , 2.3 ) If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation ( 2.1 ) Treatment of hypokalemia: Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses: limit doses to 40 mEq per dose. Total daily dose should not exceed 200 mEq ( 2.2 ) Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in divided doses; not to exceed 1 mEq/kg as a single dose or 40 mEq whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. Total daily dose should not exceed 100 mEq ( 2.3 ) Maintenance or Prophylaxis of hypokalemia: Adults: Typical dose is 20 mEq per day ( 2.2 ) Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not to exceed 3 mEq/kg/day ( 2.3 ) 2.1 Administration and Monitoring Monitoring Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis. 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 Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water [see Warnings and Precautions (5.1) ] . Take with meals or immediately after eating. If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation. 2.2 Adult Dosing Treatment of hypokalemia: Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period. Maintenance or Prophylaxis Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels. Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain. 2.3 Pediatric Dosing Treatment of hypokalemia: Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy. Maintenance or Prophylaxis Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.
Warnings & Precautions
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) ].
Contraindications
Potassium chloride is contraindicated in patients on potassium sparing diuretics. Concomitant use with potassium sparing diuretics. ( 4 )
Adverse Reactions
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 Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
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. 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 on concomitant NSAIDs.
Storage & Handling
Storage Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). Dispense in a tight, light-resistant container as defined in the USP PROTECT from LIGHT. Rx only Distributed by: American Health Packaging Columbus, OH 43217 Issued date: 08/2024
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