Description:
Lactated Ringer's and 5% Dextrose Injection USP is a sterile nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous USP*; 600 mg Sodium Chloride USP (NaCl); 310 mg Sodium Lactate (C3H5Na03); 30 mg of Potassium Chloride USP (KCl); and 20 mg Calcium Chloride USP (CaCl2 . 2H20). It contains no antimicrobial agents. Approximate pH 5.0 (4.0 to 6.5).

Lactated Ringer's and 5% Dextrose Injection USP administered intravenously has value as a source of water electrolytes and calories. One liter has an ionic concentration of 130 mEq sodium 4 mEq potassium 2.7 mEq calcium 109 mEq chloride and 28 mEq lactate. The osmolarity is 525 mOsmol/L (calc). Normal physiologic range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions may cause vein damage. The caloric content is 180 kcal/L. 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 tests for plastic containers as well as by tissue culture toxicity studies.

Clinical Pharmacology:
Lactated Ringer's and 5% Dextrose Injection USP has value as a source of water electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient. Lactated Ringer's and 5% Dextrose Injection USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water which requires the consumption of hydrogen cations.

Indications and Usage:
Lactated Ringer's and 5% Dextrose Injection USP is indicated as a source of water electrolytes and calories or as an alkalinizing agent.

Contraindications:
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Warnings:
Lactated Ringer's and 5% Dextrose Injection USP should be used with great care if at all in patients with congestive heart failure severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
Lactated Ringer's and 5% Dextrose Injection USP should be used with great care if at all in patients with hyperkalemia severe renal failure and in conditions in which potassium retention is present.
Lactated Ringer's and 5% Dextrose Injection USP should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions such as severe hepatic insufficiency.
Lactated Ringer's and 5% Dextrose Injection USP should not be administered simultaneously with blood through the same administration set because of the likelihood of coagulation.
The intravenous administration of Lactated Ringer's and 5% Dextrose Injection USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations overhydration congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.
In patients with diminished renal function administration of Lactated Ringer's and 5% Dextrose Injection USP may result in sodium or potassium retention.
Lactated Ringer's and 5% Dextrose Injection USP is not for use in the treatment of lactic acidosis.

Precautions:
Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance electrolyte concentrations and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Lactated Ringer's and 5% Dextrose Injection USP should be used with caution. Excess administration may result in metabolic alkalosis.
Caution must be exercised in the administration of Lactated Ringer's and 5% Dextrose Injection USP to patients receiving corticosteroids or corticotropin.
Lactated Ringer's and 5% Dextrose Injection USP should be used with caution in patients with overt or subclinical diabetes mellitus.
Pregnancy: Teratogenic Effects:
Pregnancy Category C. Animal reproduction studies have not been conducted with Lactated Ringer's and 5% Dextrose Injection USP.

Prescription items are NON-RETURNABLE and NON-REFUNDABLE.