DEXTROSE- dextrose monohydrate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Available from:

Baxter Healthcare Corporation

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextrose Injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 mL) drug product packaged in a vial with a 20 mm closure. The use of Dextrose Injection is contraindicated in patients with: Risk Summary Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with injectable dextrose solutions. 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 There are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or t

Product summary:

Dextrose Injection 5%, USP is a clear, sterile solutions of dextrose supplied in single-dose, partial-fill flexible containers. Product Description Size Code NDC Dextrose Injection 5%, USP (0.05 grams/mL) 50 mL 2B0040 0338-0551-11 100 mL 2B0041 0338-0551-18 Do not remove container from the overwrap until intended for use. Use the product immediately after mixing and the introduction of additives. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROSE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXTROSE INJECTION.
DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1940
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Dextrose Injection is indicated as a source of calories and water and
may also be used as diluent for reconstitution of a
powdered or liquid (up to 10 mL) drug product packaged in a vial with
a 20 mm closure. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 5% (0.05 grams/mL), 5 grams of dextrose hydrous per 100 mL
in 50 mL and 100 mL single-dose, partial-fill
flexible containers: (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions are, hyperglycemia, hypersensitivity
reactions, hyponatremia, infection both
systemic and at the injection site, vein thrombosis or phlebitis, and
electrolyte imbalance. (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
Other Products that Affect Glycemic Control, Vasopressin or Fluid
and/or Electrolyte Balance: Monitor blood glucose
concentrations, fluid balance, serum electrolyte concentrations and
acid-base balance. (7.1)
USE IN SPECIFIC POPULATIONS
Pediatric Use: Increased risk of hypoglycemia/hyperglycemia; monitor
serum glucose concentrations. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2020
Contraindications (4) 08/2019
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) 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)
Clinically significant hyperglycemia. (4)
Known hypersensitivity to dextrose. (4)
Hyperglycemia or Hyperos