Lacellate Solution

Lactated Ringer’s Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Lactated Ringer’s Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent.

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with conditions associated with increased lactate levels or impaired lactate utilization, such as severe hepatic insufficiency.

Hyperlactatemia can develop in patients with severe hepatic insufficiency, since lactate metabolism may be impaired. In addition Lactated Ringer’s Injection, USP may not produce its alkalinizing action in patients with severe hepatic insufficiency, since lactate metabolism may be impaired.

Solutions containing calcium salts should be used with caution in patients with hypercalcemia or conditions predisposing to hypercalemia, such as patients with severe renal impairment and granulomatous diseases associated with increased calcitriol synthesis such as sarcoidosis, calcium renal calculi or history of such calculi.

Lactate is a substrate for gluconeogenesis. This should be taken into account when Lactated Ringer’s Injection, USP is used in patients with type 2 diabetes.

Pediatric Use

Safety and effectiveness of Lactated Ringer’s Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of electrolyte solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

Lactate-containing solutions should be administered with particular caution to neonates and infants less than 6 months of age.

Geriatric Use

Clinical studies of Lactated Ringer’s Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Drug Interactions

Ceftriaxone – see CONTRAINDICATIONS

Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids.

Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with drugs for which renal elimination is pH dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringer’s Injection, USP may interfere with the elimination of such drugs.

Renal clearance of lithium may also be increased. Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with lithium.

Because of its potassium content, Lactated Ringer’s Injection, USP should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.

Caution is advised when administering Lactated Ringer’s Injection, USP to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

Pregnancy

Animal reproduction studies have not been conducted with Lactated Ringer’s Injection, USP. It is also not known whether Lactated Ringer’s Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Lactated Ringer’s Injection, USP should be given to a pregnant woman only if clearly needed.

For Hypersensitivity Reactions During Pregnancy – see WARNINGS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with Lactated Ringer’s Injection, USP. Studies to evaluate the possible impairment of fertility have not been performed.

Labor and Delivery

Studies have not been conducted to evaluate the effects of Lactated Ringer’s Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lactated Ringer’s Injection, USP is administered to a nursing mother.

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, paresthesias, 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

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, USP 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.

Lactated Ringer’s Injection, USP in VIAFLEX plastic container is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Medical Disclaimer