Dextrose And Sodium Chloride

DEXTROSE AND SODIUM CHLORIDE- dextrose and sodium chloride injection, solution
B. Braun Medical Inc.

DESCRIPTION

(See chart below for quantitative information.)

Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration.

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Sodium Chloride USP	NaCl	58.44
Hydrous Dextrose USP		198.17

Composition – Each 100 mL contains:			Concentration of Electrolytes(mEq/liter)
	Hydrous Dextrose USP	Sodium Chloride USP			Calories per liter	Calculated OsmolaritymOsmol/liter	pH
Solution			Sodium	Chloride
	Water for Injection USP qs
3.3% Dextrose and 0.30% Sodium Chloride Injection USP	3.3 g	0.3 g	51	51	110	270	4.5 (3.5–6.5)
5% Dextrose and 0.9% Sodium Chloride Injection USP	5 g	0.9 g	154	154	170	560	4.4 (3.5–6.5)
5% Dextrose and 0.45% Sodium Chloride Injection USP	5 g	0.45 g	77	77	170	405	4.4 (3.5–6.5)
5% Dextrose and 0.33% Sodium Chloride Injection USP	5 g	0.33 g	56	56	170	365	4.4 (3.5–6.5)
5% Dextrose and 0.20% Sodium Chloride Injection USP	5 g	0.2 g	34	34	170	320	4.4 (3.5–6.5)
10% Dextrose and 0.45% Sodium Chloride Injection USP	10 g	0.45 g	77	77	340	660	4.3 (3.5–6.5)
10% Dextrose and 0.20% Sodium Chloride Injection USP	10 g	0.2 g	34	34	340	575	4.3 (3.5–6.5)

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. 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 administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

CLINICAL PHARMACOLOGY

Dextrose and Sodium Chloride Injections USP provide electrolytes and calories and are a source of water for hydration. All are capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Dextrose provides a source of calories. 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.

INDICATIONS AND USAGE

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration.

CONTRAINDICATIONS

These solutions are contraindicated where the administration of sodium or chloride could be clinically detrimental.

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.