Potassium Chloride Extended-Release 750 mg/1
Potassium Chloride Extended-Release · TABLET, EXTENDED RELEASE · NCS HealthCare of KY, LLC dba Vangard Labs
Potassium Chloride Extended-Release is a prescription medication used to treat or prevent low potassium levels in the blood. This tablet releases potassium slowly in your body to help maintain proper heart rhythm, muscle function, and nerve transmission.
Key Facts
- Brand Name
- Potassium Chloride Extended-Release
- Generic Name
- Potassium Chloride Extended-Release
- NDC Code (Product)
0615-8399- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Strength
- 750 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214452
- Marketing Start
- 01/30/2021
Recall History
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed Dissolution Specifications.
Amerisource Health Services LLC
Failed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications
Strides Pharma Science Limited
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Strides Pharma Inc.
Failed Dissolution Specifications
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 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 concentration 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. ( 2.1 ) Treatment of hypokalemia : Typical dose range is 40-100 mEq per day in divided doses. Limit doses to 20 mEq per dose. ( 2.2 ) Prevention of hypokalemia : Typical dose is 20 mEq per day ( 2.2 ) 2.1 Monitoring and Administration If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust the dose based on serum potassium level. 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 balanc…
Contraindications
4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on triamterene or amiloride. Concomitant use with triamterene and amiloride ( 4 , 7.1 )
Drug Interactions
7 DRUG INTERACTIONS Renin-angiotensin-aldosterone system inhibitors: Monitor for hyperkalemia ( 7.2 ) Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia ( 7.3 ) 7.1 Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications (4) ] . 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 Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients receiving concomitant NSAID therapy.
Adverse Reactions
6 ADVERSE REACTIONS 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, perforation [see Warnings and Precautions (5.1) and Overdosage (10) ] . Skin rash has been reported rarely. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Potassium Chloride Extended-Release used for?
Potassium Chloride Extended-Release is a prescription medication used to treat or prevent low potassium levels in the blood. This tablet releases potassium slowly in your body to help maintain proper heart rhythm, muscle function, and nerve transmission.
Is Potassium Chloride Extended-Release a controlled substance?
Potassium Chloride Extended-Release is not classified as a controlled substance by the DEA.
What is the generic name for Potassium Chloride Extended-Release?
The generic name for Potassium Chloride Extended-Release is Potassium Chloride Extended-Release. There are 11 other brand versions of Potassium Chloride Extended-Release.
What is the NDC code for Potassium Chloride Extended-Release 750 mg/1?
The NDC (National Drug Code) for Potassium Chloride Extended-Release 750 mg/1 is 0615-8399, listed by NCS HealthCare of KY, LLC dba Vangard Labs.
Other Potassium Brands
See all →- Potassium Chloride Extended-release750 mg/170518-4095
- Potassium Chloride Extended-release750 mg/168001-566
- Potassium Chloride Extended-release750 mg/170010-136
- POTASSIUM CHLORIDE750 mg/143547-549
- Potassium Chloride Extended-release1500 mg/168788-8196
- Potassium Chloride Extended-release1500 mg/171335-1896
- Potassium Chloride Extended-release1500 mg/117856-1135
- Potassium Chloride Extended-release1500 mg/167296-2160
- Potassium Chloride Extended-release1500 mg/170518-4383
- Potassium Chloride Extended-release1500 mg/162207-727
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)