Potassium Chloride 20 meq/15mL
Potassium Chloride · SOLUTION · Macleods Pharmaceuticals Limited
Potassium chloride oral solution is a prescription medication used to treat or prevent low potassium levels in the blood. Each 15 milliliter dose contains 20 milliequivalents of potassium chloride.
Key Facts
- Brand Name
- Potassium Chloride
- Generic Name
- Potassium Chloride
- NDC Code (Product)
33342-511- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 20 meq/15mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218733
- Marketing Start
- 05/26/2023
Recall History
Hospira Inc.
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
RemedyRepack Inc.
CGMP Deviations: Out of specification for dissolution
Qualitest Pharmaceuticals
LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.
Novel Laboratories, Inc. d.b.a Lupin Somerset
Defective container: potential for non-sealed pouches which can lead to product leakage.
Baxter Healthcare Corp.
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
B. Braun Medical Inc
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
CMC Enterprise Pharmacy
Lack of sterility assurance.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed Dissolution Specifications.
Pharmedium Services, LLC
Lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. (2.1) Treatment of hypokalemia : Doses range from 40 to 100 mEq/day in divided doses. Limit doses to 40 mEq per dose. (2.2) Prevention of hypokalemia : Typical dose is 20 mEq per day. (2.2) 2.1 Administration and Monitoring If serum potassium concentration is less than 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 electr…
Contraindications
4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on triamterene and amiloride. Concomitant use with triamterene and amiloride (4)
Drug Interactions
7 DRUG INTERACTIONS 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) 7.1 Triamterene or amiloride 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-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. 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) 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.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation. Skin rash has been reported rarely.
Frequently Asked Questions
What is Potassium Chloride used for?
Potassium chloride oral solution is a prescription medication used to treat or prevent low potassium levels in the blood. Each 15 milliliter dose contains 20 milliequivalents of potassium chloride.
Is Potassium Chloride a controlled substance?
Potassium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Potassium Chloride?
The generic name for Potassium Chloride is Potassium Chloride. There are 5 other brand versions of Potassium Chloride.
What is the NDC code for Potassium Chloride 20 meq/15mL?
The NDC (National Drug Code) for Potassium Chloride 20 meq/15mL is 33342-511, listed by Macleods Pharmaceuticals Limited.