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:

Cardinal Health

INN (International Name):

DEXTROSE MONOHYDRATE

Composition:

DEXTROSE MONOHYDRATE 50 g in 1000 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dextrose Injection, USP is indicated as a source of water and calories. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Product summary:

Dextrose Injection, USP in VIAFLEX plastic container is available as follows: 5% Dextrose Injection USP 500 mL available overbagged with 1 x 500 mL Viaflex Container per bag, NDC 55154-2887-8. 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. Repackaged By: Cardinal Health Zanesville, OH 43701

Authorization status:

New Drug Application

Summary of Product characteristics

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
CARDINAL HEALTH
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DEXTROSE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
DESCRIPTION
Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid
replenishment and caloric supply in
single dose containers for intravenous administration. It contains no
antimicrobial agents. Composition,
osmolarity, pH, and caloric content are shown in Table 1.
TABLE 1
SIZE
(ML)
* DEXTROSE
HYDROUS,
USP (G/L)
OSMOLARITY
(MOSMOL/L)
(CALC.)
PH
CALORIC
CONTENT
(KCAL/L)
5% Dextrose
Injection, USP
25
50
252
4.0
(3.2 to 6.5)
170
Quad pack
50
Single pack
Quad pack
Multi pack
100
Single pack
Quad pack
Multi pack
150
250
500
1000
10% Dextrose
Injection, USP
250
500
1000
100
505
4.0
(3.2 to 6.5)
340
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146
Plastic). The amount of water that can permeate from inside the
container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container can leach
out certain of its chemical components in very small amounts within
the expiration period, e.g., di-2-
ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the
safety of the plastic has been
confirmed in tests in animals according to USP biological test for
plastic containers as well as by tissue
culture toxicity studies.
CLINICAL PHARMACOLOGY
Dextrose Injection, USP has value as a source of water and calories.
It is capable of inducing diuresis
depending on the clinical condition of the patient.
INDICATIONS AND USAGE
Dextrose Injection, USP is indicated as a source of water and
calories.
CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with
known allergy to corn or corn
products.
WARNINGS
Dextrose Injection, USP should not be administered simultaneously with
blood through the same
administration set because of the possibility of pseudoagglutination
or hemolysis.
The intravenous administration of these solutions can cause fluid
and/or solu