Drugplain

Potassium Chloride for Oral Solution 1.5 g/1.58g

Potassium Chloride for Oral Solution · SOLUTION · Marlex Pharmaceuticals Inc

1 Recall on RecordCurrently in Shortage
Plain English

Potassium Chloride for Oral Solution is a solution containing potassium chloride for oral solution at 1.5 g/1.58g, taken oral. Manufactured by Marlex Pharmaceuticals Inc.

Key Facts

Brand Name
Potassium Chloride for Oral Solution
Generic Name
Potassium Chloride for Oral Solution
NDC Code (Product)
10135-819
Manufacturer
Marlex Pharmaceuticals Inc
Strength
1.5 g/1.58g
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA212183
Marketing Start
08/01/2025

Recall History

1 Recall on Record
Class II03/19/2019

LUPIN SOMERSET

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea6,580 reports
dyspnoea6,487 reports
nausea6,332 reports
fatigue6,137 reports
death4,498 reports
pneumonia4,401 reports
asthenia4,077 reports
vomiting4,034 reports
headache3,974 reports
off label use3,939 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND 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

2 DOSAGE AND 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 If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or

Contraindications

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

Drug Interactions

7 DRUG INTERACTIONS • Potassium sparing diuretics: Avoid concomitant use ( 7.1 ) • Angiotensin converting enzyme inhibitors: Monitor for hyperkalemia ( 7.2 ) • Angiotensin receptor blockers: Monitor for hyperkalemia ( 7.3 ) 7.1 Potassium-Sparing Diuretics Use with potassium-sparing diuretic can produce severe hyperkalemia. Avoid concomitant use. 7.2 Angiotensin-Converting Enzyme Inhibitors Use with angiotensin converting enzyme (ACE) inhibitors produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring. 7.3 Angiotensin Receptor Blockers Use with angiotensin receptor blockers (ARBs) produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ARBs only with close monitoring.

Adverse Reactions

6 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 BPI Labs, LLC. at 1-727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Potassium Chloride for Oral Solution used for?

Potassium Chloride for Oral Solution contains Potassium Chloride for Oral Solution. It is a solution taken oral. Consult your doctor for specific uses.

Is Potassium Chloride for Oral Solution a controlled substance?

Potassium Chloride for Oral Solution is not classified as a controlled substance by the DEA.

What is the generic name for Potassium Chloride for Oral Solution?

The generic name for Potassium Chloride for Oral Solution is Potassium Chloride for Oral Solution. There are no other listed brand versions of Potassium Chloride for Oral Solution.

What is the NDC code for Potassium Chloride for Oral Solution 1.5 g/1.58g?

The NDC (National Drug Code) for Potassium Chloride for Oral Solution 1.5 g/1.58g is 10135-819, listed by Marlex Pharmaceuticals Inc.

Product NDC

10135-819

Package NDC

10135-819-08

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)