Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride oral solution, USP is a clear orange liquid with citrus aroma, available in two strengths and supplied as Unit Dose Cups for institutional use only, as follows: 10%: 20 mEq/15 mL oral solution NDC# 81033-220-52 15 mL (20 mEq) fill, case of 5 trays x 10s NDC# 81033-220-51 15 mL (20 mEq) fill, case of 10 trays x 10s NDC# 81033-240-50 30 mL (40 mEq) fill, case of 5 trays x 10s NDC# 81033-240-51 30 mL (40 mEq) fill, case of 10 trays x 10s 20%: 40 mEq/15 mL oral solution NDC# 81033-440-50 15 mL (40 mEq) fill, case of 5 trays x 10s NDC# 81033-440-51 15 mL (40 mEq) fill, case of 10 trays x 10s Storage Store at 20° to 25°C (68° to 77°F), with 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. Keep tightly closed. PROTECT from LIGHT and FREEZING. Rx only Distributed by: Kesin Pharma Corporation Oldsmar, FL 34677 Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 08/22-R1; Package/Label Display Panel 81033-220-15 Potassium Chloride Oral Solution USP, 10% 20 mEq/15 mL DILUTE PRIOR TO ADMINISTRATION Unit dose delivers 15 mL Orange Flavor 20 mEq Label; Package/Label Display Panel NDC 81033-220-52 Potassium Chloride Oral Solution USP, 10% 20 mEq/15 mL per cup Unit-dose delivers 15 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 5 Trays contain 50 Unit-dose Cups 20 mEq Label; Package/Label Display Panel NDC 81033-220-51 Potassium Chloride Oral Solution USP, 10% 20 mEq/15 mL per cup Unit-dose delivers 15 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 10 Trays contain 100 Unit-dose Cups 20 mEq Label; Package/Label Display Panel 81033-240-30 Potassium Chloride Oral Solution USP, 10% 40 mEq/30 mL DILUTE PRIOR TO ADMINISTRATION Unit dose delivers 30 mL Orange Flavor 40 mEq Label; Package/Label Display Panel NDC 81033-240-50 Potassium Chloride Oral Solution USP, 10% 40 mEq/30 mL per cup Unit-dose delivers 30 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 5 Trays contain 50 Unit-dose Cups 40 mEq Label; Package/Label Display Panel NDC 81033-240-51 Potassium Chloride Oral Solution USP, 10% 40 mEq/30 mL per cup Unit-dose delivers 30 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 10 Trays contain 100 Unit-dose Cups 40 mEq Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride oral solution, USP is a clear orange liquid with citrus aroma, available in two strengths and supplied as Unit Dose Cups for institutional use only, as follows: 10%: 20 mEq/15 mL oral solution NDC# 81033-220-52 15 mL (20 mEq) fill, case of 5 trays x 10s NDC# 81033-220-51 15 mL (20 mEq) fill, case of 10 trays x 10s NDC# 81033-240-50 30 mL (40 mEq) fill, case of 5 trays x 10s NDC# 81033-240-51 30 mL (40 mEq) fill, case of 10 trays x 10s 20%: 40 mEq/15 mL oral solution NDC# 81033-440-50 15 mL (40 mEq) fill, case of 5 trays x 10s NDC# 81033-440-51 15 mL (40 mEq) fill, case of 10 trays x 10s Storage Store at 20° to 25°C (68° to 77°F), with 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. Keep tightly closed. PROTECT from LIGHT and FREEZING. Rx only Distributed by: Kesin Pharma Corporation Oldsmar, FL 34677 Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 08/22-R1
- Package/Label Display Panel 81033-220-15 Potassium Chloride Oral Solution USP, 10% 20 mEq/15 mL DILUTE PRIOR TO ADMINISTRATION Unit dose delivers 15 mL Orange Flavor 20 mEq Label
- Package/Label Display Panel NDC 81033-220-52 Potassium Chloride Oral Solution USP, 10% 20 mEq/15 mL per cup Unit-dose delivers 15 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 5 Trays contain 50 Unit-dose Cups 20 mEq Label
- Package/Label Display Panel NDC 81033-220-51 Potassium Chloride Oral Solution USP, 10% 20 mEq/15 mL per cup Unit-dose delivers 15 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 10 Trays contain 100 Unit-dose Cups 20 mEq Label
- Package/Label Display Panel 81033-240-30 Potassium Chloride Oral Solution USP, 10% 40 mEq/30 mL DILUTE PRIOR TO ADMINISTRATION Unit dose delivers 30 mL Orange Flavor 40 mEq Label
- Package/Label Display Panel NDC 81033-240-50 Potassium Chloride Oral Solution USP, 10% 40 mEq/30 mL per cup Unit-dose delivers 30 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 5 Trays contain 50 Unit-dose Cups 40 mEq Label
- Package/Label Display Panel NDC 81033-240-51 Potassium Chloride Oral Solution USP, 10% 40 mEq/30 mL per cup Unit-dose delivers 30 mL Orange Flavor DILUTE PRIOR TO ADMINISTRATION Rx only 10 Trays contain 100 Unit-dose Cups 40 mEq Label
Overview
Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.
Indications & Usage
Potassium chloride 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 are insufficient. 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 are insufficient. ( 1 )
Dosage & Administration
Dilute prior to administration. ( 2.1 , 5.1 ) Monitor serum potassium and adjust dosage accordingly. ( 2.2 , 2.3 ) Treatment of hypokalemia: Adults: Initial doses range from 40 to 100 mEq/day in 2 to 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 to 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 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 potassium chloride oral solution with 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 ranges 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 if administered undiluted. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration ( 2.1 )] .
Contraindications
Potassium chloride oral solution 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 Saptalis Pharmaceuticals, LLC at 1-833-727-8254 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.
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