POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- potassium chloride, dextrose monohydrate and sodium chloride injection, solu

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Baxter Healthcare Corporation

INN (International Name):

POTASSIUM CHLORIDE

Composition:

POTASSIUM CHLORIDE 150 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Potassium Chloride in Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in Dextrose and Sodium Chloride Injection is contraindicated in patients with: Risk Summary Appropriate administration of Potassium Chloride in Dextrose Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in Dextrose Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Risk Summary Sodium and potassium are present in human breast milk. There are no data on the effects

Product summary:

Potassium Chloride in Dextrose and Sodium Chloride Injection, are clear solutions in 500 mL and 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC mEq Potassium Product Name 2B1614 2B1613 1000 500 0338-0663-04 0338-0663-03 20 mEq/L 10 mEq/L Potassium Chloride in 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1473 500 0338-0603-03 10 mEq/L Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection, USP 2B1644 1000 0338-0669-04 10 mEq/L 2B1654 2B1653 2B1664 1000 500 1000 0338-0671-04 0338-0671-03 0338-0673-04 20 mEq/L 10 mEq/L 30 mEq/L Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1674 1000 0338-0675-04 40 mEq/L 2B2434 1000 0338-0803-04 20 mEq/L Potassium Chloride in 5% Dextrose and 2B2454 1000 0338-0807-04 40 mEq 0.9% Sodium Chloride Injection, USP Storage : Avoid excessive heat. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- POTASSIUM
CHLORIDE,
DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
REFERENCE LABEL SET ID: 9714FDB7-6C16-424E-A030-CDDAA8FC8838
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE IN DEXTROSE
AND SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR POTASSIUM
CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTION.
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1979
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Potassium Chloride in Dextrose and Sodium Chloride Injection is
indicated as a source of water, electrolytes and calories.
(1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Potassium Chloride in Dextrose and Sodium Chloride Injection is
available in multiple strengths. See full prescribing
information for detailed description of each formulation. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
•
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Contraindications (4) 02/2019
Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 )
02/2019
Only for intravenous infusion. (2.1, 5.2)
See full prescribing information for information on preparation,
administration, dosing considerations and instructions
for use. (2.1, 2.2, 2.3)
Known hypersensitivity to potassium chloride, dextrose, or sodium
chloride (4, 5.1)
Clinically significant hyperkalemia (4, 5.2)
Clinically significant hyperglycemia (4, 5.3)
Hypersensitivity Reactions: monitor