Lactated Ringer with 5% Dextrose Rx, USP
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
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.
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.
Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Potassium containing solutions should be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.
Solutions containing lactate ions should be used with caution as excess administration may result in metabolic alkalosis.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Pregnancy Category C. Animal reproduction studies have not been conducted with Ringer's Injection, USP, Ringer's and Dextrose Injection, USP, Lactated Ringer's Injection, USP or Lactated Ringer's and Dextrose Injection, USP. It is also not known whether these injections can cause fetal harm when EN-2203 Page 4 of 5 administered to a pregnant woman or can affect reproduction capacity. These injections should be given to a pregnant woman only if clearly needed.
Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.