DEXTROSE AND SODIUM CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextrose and Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. Dextrose and Sodium Chloride Injection is contraindicated in patients with: Risk Summary Appropriate administration of Dextrose and Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Dextrose and 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 is present in human breast milk. There are no data on the effects of Dextrose and Sodium Chloride Injection on a breastfed infant or the effects on milk producti

Product summary:

Dextrose and Sodium Chloride Injection are clear solutions in 250 mL, 500 mL and 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC Product Name 2B1024 1000 0338-0073-04 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1092 250 0338-0077-02 5% Dextrose and 0.2% Sodium Chloride Injection, USP 2B1093 500 0338-0077-03 2B1094 1000 0338-0077-04 2B1083 500 0338-0081-03 5% Dextrose and 0.33% Sodium Chloride Injection, USP 2B1073 500 0338-0085-03 5% Dextrose and 0.45% Sodium Chloride Injection, USP 2B1074 1000 0338-0085-04 2B1063 500 0338-0089-03 5% Dextrose and 0.9% Sodium Chloride Injection, USP 2B1064 1000 0338-0089-04 Storage : Avoid excessive heat. Store at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE AND SODIUM CHLORIDE- DEXTROSE AND SODIUM CHLORIDE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROSE AND SODIUM CHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DEXTROSE AND SODIUM CHLORIDE
INJECTION.
DEXTROSE AND SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1970
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Dextrose and Sodium Chloride Injection is indicated as a source of
water, electrolytes and calories. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Dextrose and Sodium Chloride Injection is available in multiple
strengths. See full prescribing information for detailed
description of each product. (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: 8/2019
Contraindications (4) 08/2019
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7) 08/2019
Only for intravenous infusion. (2.1)
See full prescribing information for information on preparation,
administration, dosing considerations and instructions
for use. (2.1, 2.2, 2.3)
Known hypersensitivity to dextrose, or sodium chloride (4, 5.1)
Clinically significant hyperglycemia (4, 5.2)
Hypersensitivity Reactions: Monitor for signs and symptoms and
discontinue infusion if reactions occur. (5.1)
Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood
glucose and administer insulin as needed. (5.2,
8.4)
Hyponatremia, Hypokalemia, Hypernatremia and Hyperchloremia: Avoid in
patients with or at risk for hypo-
/hypernatremia and hypokalemia. If use cannot be avoided, monitor
serum sodium and po