INDICATIONS AND USAGE: Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.

WARNINGS: Although Lactated Ringer's Injection has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it should not be used for this purpose.

Lactated Ringer's Injection is not for use for the treatment of lactic acidosis or severe metabolic acidosis.

Lactated Ringer's Injection should not be administered simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation.

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop.

Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Hypersensitivity reactions are reported more frequently during pregnancy.

Depending on the volume and the rate of infusion, the intravenous administration of Lactated Ringer's Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema or acid-base imbalance.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation.

Lactated Ringer's Injection should be administered with particular caution, if at all, to patients with hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with cardiac disease.

Lactated Ringer's Injection should be administered with particular caution, if at all, to patients with alkalosis or at risk for alkalosis.

Because lactate is metabolized to bicarbonate, administration may result in, or worsen, metabolic alkalosis.

Lactated Ringer's Injection should be administered with particular caution, if at all, to patients with severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or potassium retention, fluid overload, or edema.

ADVERSE REACTIONS: Post-Marketing Adverse Reactions The following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC).

Immune System Disorders Hypersensitivity/infusion reactions, including anaphylactic/anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, blood pressure decreased, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, hypoesthesia oral, dysgeusia, nausea, anxiety, pyrexia, headache.

Metabolism and Nutrition Disorders Hyperkalemia.

General Disorders and Administration Site Conditions Infusion site reactions, including phlebitis, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning.

Class Reactions Hypersensitivity reactions, including, laryngeal edema and sneezing Hypervolemia Infusion site reactions, including infection at the site of injection, extravasation, and infusion site anesthesia (numbness) Overdose An excessive volume or too high a rate of administration of Lactated Ringer's Injection may lead to fluid and sodium overload with a risk of edema (peripheral and/or pulmonary), particularly when renal sodium excretion is impaired.

Excessive administration of lactate may lead to metabolic alkalosis.

Metabolic alkalosis may be accompanied by hypokalemia.

Excessive administration of potassium may lead to the development of hyperkalemia, especially in patients with severe renal impairment.

Excessive administration of calcium salts may lead to hypercalcemia.

When assessing an overdose, any additives in the solution must also be considered.

The effects of an overdose may require immediate medical attention and treatment.