DEXTROSE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2)

Available from:

B. Braun Medical Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

70% Dextrose Injection USP is indicated as a caloric component in a parenteral nutrition regimen. 70% Dextrose Injection USP is used with an appropriate protein (nitrogen) source in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. The infusion of 70% Dextrose Injection USP  is contraindicated in patients having intracranial or intraspinal hemorrhage, in patients who are severely dehydrated, in patients who are anuric, and in patients in hepatic coma. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Product summary:

70% Dextrose Injection USP is supplied in 2000 mL Pharmacy Bulk Package containers packaged 4 per case. NDC                    REF           SIZE 0264-7387-50     S8705        2000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE- DEXTROSE SOLUTION
B. BRAUN MEDICAL INC.
----------
70% DEXTROSE INJECTION USP
Concentrated Dextrose in Water
PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION.
NOTE: THIS SOLUTION IS HYPERTONIC — SEE WARNINGS AND PRECAUTIONS.
DESCRIPTION
Each 100 mL of 70% DEXTROSE INJECTION USP contains:
Hydrous Dextrose USP 70 g; Water for Injection USP qs
pH: 4.0 (3.2-6.5); Calculated Osmolarity: 3532 mOsmol/liter,
hypertonic.
Specific gravity 1.233 at 25°C
Calories per liter: 2380 calculated on the basis of 3.4 kcal/g of
dextrose, hydrous
70% Dextrose Injection USP is sterile, nonpyrogenic and contains no
bacteriostatic or
antimicrobial agents. This product is intended for intravenous
administration after
appropriate admixture or dilution as a caloric source.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA MOLECULAR WEIGHT
Hydrous Dextrose USP
198.17
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically
developed for
parenteral drugs. The solution contact layer is a rubberized copolymer
of ethylene and
propylene. The container is nontoxic and biologically inert. The
container-solution unit is
a closed system and is not dependent upon entry of external air during
use. The
container is overwrapped to provide protection from the physical
environment and to
provide an additional moisture barrier when necessary.
CLINICAL PHARMACOLOGY
70% Dextrose Injection USP provides calories and is a source of water
for hydration. It
is capable of inducing diuresis depending on the clinical condition of
the patient.
Dextrose is readily metabolized, may decrease losses of body protein
and nitrogen,
promotes glycogen deposition and decreases or prevents ketosis if
sufficient doses are
provided.
Water is an essential constituent of all body tissues and accounts for
approximately
70% of total body weight. Average normal adult daily requirements
range from two to
three liters (1.0 to 1.5 liters each for insensible water loss by
perspiration and urine
pr