DEXTROSE- dextrose monohydrate injection, solution

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

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextrose Injection is indicated as source of water and calories. 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 the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Dextrose Injection to

Product summary:

Dextrose Injection, USP are clear, colorless, sterile solutions of dextrose supplied in VIAFLO dripless access containers (DAC) and non-DAC plastic containers are shown below. VIAFLO DAC will not drip once the spike is removed. VIAFLO non-DAC will drip once the spike is removed from the administration port. Product Description Size Code NDC Dextrose Injection 5%, USP (0.05 grams/mL) 250 mL (DAC) 250 mL (Non-DAC) 500 mL (DAC) 500 mL (Non-DAC) 1000 mL (DAC) 1000 mL (Non-DAC) UE0062D UE0062 UE0063D UE0063 UE0064D UE0064 0338-0062-30 0338-0074-30 0338-0066-20 0338-0078-20 0338-0070-10 0338-0082-10 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); brief exposure up to 40°C/104°F does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
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 water and calories. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Inje ction:
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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: 8/2020
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)
5% (0.05 grams/mL): 5 grams of dextrose hydrous per 100 mL in
single-dose partial-fill flexible containers: 250 mL,
500 mL, and 1000 mL. (3)
Clinically significant hyperglycemia. (4)
Known hypersensitivity to dextrose. (4)
Hyperglycemia or Hyperosmolar Hyperglycemic State: Monitor blood
glucose and administer insulin as needed. (5.1)
Hypersensitivity Rea