Potassium Chloride in Dextrose
Generic: POTASSIUM CHLORIDE AND DEXTROSE MONOHYDRATE
Basic Information
Manufacturer
Baxter Healthcare Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
45de5402-5e61-4bbd-8bbc-5e3392c9920e
Indications & Usage
1 INDICATIONS AND USAGE Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories.
Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories.
(1)
Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories.
(1)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in Dextrose Injection were identified in post marketing 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 : including anaphylaxis and chills [see Warnings and Precautions (5.1) ] .
• Hyperkalemia, including cardiac arrest, as a manifestation [see Warnings and Precautions (5.2) ] • Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] • Hypokalemia [see Warnings and Precautions (5.5) ] • Hypervolemia [see Warnings and Precautions (5.6) ] • Injection site reactions : infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, infusion site rash, infusion site pain, infusion site vesicles, infusion site pruritus, pyrexia and chills 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.
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 : including anaphylaxis and chills [see Warnings and Precautions (5.1) ] .
• Hyperkalemia, including cardiac arrest, as a manifestation [see Warnings and Precautions (5.2) ] • Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions (5.4) ] • Hypokalemia [see Warnings and Precautions (5.5) ] • Hypervolemia [see Warnings and Precautions (5.6) ] • Injection site reactions : infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, infusion site rash, infusion site pain, infusion site vesicles, infusion site pruritus, pyrexia and chills 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.