View Drug - Potassium Chloride in Lactated Ringers and Dextrose
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Potassium Chloride in Lactated Ringers and Dextrose

Generic: DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE

100%
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
05f326e6-10e4-4ceb-8a23-f53c592f00b8
Indications & Usage
1 INDICATIONS AND USAGE Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.

Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.

( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ] • Air Embolism [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Potassium Imbalances [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Neonatal Hypoglycemia [see Warnings and Precautions (5.6) ] • Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.7) ] • Hypercalcemia [see Warnings and Precautions (5.8) ] • Fluid Overload [see Warnings and Precautions (5.9) ] • Acid/Base Imbalances [see Warnings and Precautions (5.10) ] The following adverse reactions have been identified during postapproval use of Lactated Ringer’s products.

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: General Disorders and Administration Site Conditions: Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia.

Hypersensitivity Reactions and Infusion Reactions: Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, and headache, laryngeal edema, sneezing, injection site infection.

Metabolism and Nutrition Disorders: Hyperkalemia, hyponatremia, and hypervolemia.

Nervous System Disorders: Hyponatremic encephalopathy.

Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough).

( 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.