LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride and calcium chloride injection, solution
B. Braun Medical Inc.
DESCRIPTION
Each 100 mL of Lactated Ringer's Injection USP contains:
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 may be adjusted with Hydrochloric Acid NF or Sodium Hydroxide NF
pH: 6.2 (6.0�7.5) Calculated Osmolarity: 275 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 130; Potassium 4 Calcium 3; Chloride 110; Lactate (CH3 CH(OH)COO?) 28
Lactated Ringer's Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration in a single dose container.
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
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
Lactated Ringer's Injection USP provides electrolytes 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.
INDICATIONS AND USAGE
This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.
