POTASSIUM CHLORIDE IN DEXTROSE- potassium chloride and dextrose monohydrate injection, solution

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)

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 Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in Dextrose Injection is contraindicated in patients with: Risk Summary Appropriate administration of Potassium Chloride in Dextrose 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 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 Potassium is present in human breast milk. There are no data on the effects of Potassium Chloride in Dextrose Injection on a breastfed infant or the effects on

Product summary:

Potassium Chloride in 5% Dextrose Injection, is a clear solution in 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC Product Name 2B1134 1000 0338-0683-04 20 mEq Potassium Chloride in 5% Dextrose 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- POTASSIUM CHLORIDE AND DEXTROSE
MONOHYDRATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTASSIUM CHLORIDE IN DEXTROSE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
POTASSIUM CHLORIDE IN
DEXTROSE INJECTION.
POTASSIUM CHLORIDE IN DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1979
RECENT MAJOR CHANGES
Contraindications (4) 07/2019
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7) 07/2019
INDICATIONS AND USAGE
Potassium Chloride in Dextrose Injection is indicated as a source of
water, electrolytes and calories. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 20 mEq Potassium Chloride in 5% Dextrose Injection, USP in
a 1000 mL single-dose flexible container. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
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 or dextrose (4, 5.1)
Clinically significant hyperkalemia (4, 5.2)
Clinically significant hyperglycemia (4, 5.3)
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