Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
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)
Baxter Healthcare Corporation
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 150 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
New Drug Application
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 ---------- 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 Прочетете целия документ