DEXTROSE IN LACTATED RINGERS- dextrose monohydrate, sodium chloride, sodium lactate, potassium chloride and calcium chloride injection, solution
B. Braun Medical Inc.
DESCRIPTION
Each 100 mL of 5% Dextrose in Lactated Ringer�s Injection contains:
Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.6 g
Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g
Calcium Chloride Dihydrate USP 0.02 g
Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 4.6 (4.0�6.0)
Calories per liter: 170
Calculated Osmolarity: 530 mOsmol/liter, hypertonic
Concentration of Electrolytes (mEq/liter): Sodium 130 Potassium 4Calcium 3 Chloride 112 Lactate (CH3 CH(OH)COO?) 28
5% Dextrose in Lactated Ringer�s Injection is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.
The formulas of the active ingredients are:
Ingredients Molecular Formula Molecular Weight
Sodium Chloride USP NaCl 58.44
Sodium Lactate CH3 CH(OH)COONa 112.06
Potassium Chloride USP KCl 74.55
Calcium Chloride Dihydrate USP CaCl2 �2H2 O 147.02
Hydrous Dextrose USP Chemical Structure 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. 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
5% Dextrose in Lactated Ringer�s Injection provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. This solution also contains lactate which produces a metabolic alkalinizing effect.
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. Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.
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. Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.
Sodium lactate is a racemic salt containing both the levo form, which is oxidized by the liver to bicarbonate, and the dextro form, which is converted to glycogen. Lactate is slowly metabolized to carbon dioxide and water, accepting one hydrogen ion and resulting in the formation of bicarbonate for the lactate consumed. These reactions depend on oxidative cellular activity.
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
This solution is indicated for use in adults and pediatric patients as a source of electrolytes, calories and water for hydration.