Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Dextrose and Sodium Chloride Injection were identified in postmarketing reports.
Because these reactions were 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 following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions : anaphylaxis, rash and pruritus [see Warnings and Precautions (5.1) ].
• Metabolism and Nutrition Disorders : hyperkalemia [see Warnings and Precautions (5.2) ], hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions (5.3) ], hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ], fluid overload [see Warnings and Precautions (5.6) ] and refeeding syndrome [see Warnings and Precautions (5.2) ].
Hypernatremia and hyperchloremia acidosis [see Warnings and Precautions (5.5) ] have been observed in solutions containing 0.9% sodium chloride.
• Cardiac Disorder : cardiac arrest as a manifestation of rapid intravenous administration and/or of hyperkalemia [see Warnings and Precautions (5.2) ].
• Infusion Site Reactions : injection site vesicles, extravasation, venous thrombosis or phlebitis, infusion site pain.
Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur.
( 5.1 ) • Hyperkalemia : May result in cardiac arrhythmias.
Avoid use in patients with, or at risk for, hyperkalemia.
If use cannot be avoided, use a product with a low amount of potassium chloride, infuse slowly and monitor serum potassium concentrations and ECGs.
( 5.2 ) • Hyperglycemia or Hyperosmolar Hyperglycemic State : Monitor blood glucose and administer insulin as needed.
Like all medications, Potassium Chloride In Dextrose And Sodium Chloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: