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Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride

FDA Drug Information • Also known as: Lactated Ringers

Brand Names
Lactated Ringers
Route
IRRIGATION
Dosage Form
IRRIGANT
Product Type
HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C 3 H 5 NaO 3 ), 300 mg Potassium Chloride, USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl 2

  • 2H 2 O). pH 6.5 (6.0 to 7.5). Milliequivalents per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109, Lactate - 28. Osmolarity 273 mOsmol/L (calc.). No antimicrobial agent has been added. The ARTHROMATIC 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-ethylhexylphthalate (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.

    • What Is Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride Used For?

    INDICATIONS AND USAGE Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

    Dosage and Administration

    DOSAGE AND ADMINISTRATION The volume and/or rate of solution needed will vary with the nature and duration of the arthroscopic procedure. This solution, as it is packaged, is not intended for IV administration or injection. The container must not be vented (See Precautions ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact. If particulate matter or discoloration is found, contact Baxter Customer Service Aseptic technique should be used when applying this product. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added. When using Lactated Ringer’s Irrigation for pour irrigation, prevent contact of the fluid with the external surface of the container. Lactated Ringer’s Irrigation is for single-patient use only. Microwave heating of irrigation fluids is not recommended. If desired, Lactated Ringer’s Irrigation may be warmed in a water bath or oven to not more than 45° C while maintaining sterility. Lactated Ringer’s Irrigation that has been warmed must not be returned to storage. Cetriaxone must not be mixed with calcium-containing solutions, including Lactated Ringer’s Irrigation. Additives may be incompatible with Lactated Ringer’s Irrigation. Additives known or determined to be incompatible should not be used. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for, for example, a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals. Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Lactated Ringer’s Irrigation is appropriate. The instructions for use of the medication to be added and other relevant literature must be consulted. When making additions to Lactated Ringer’s Irrigation, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

    Side Effects (Adverse Reactions)

    ADVERSE REACTIONS Post-Marketing Adverse Reactions No adverse reactions were identified in Baxter’s Adverse Event Reporting System database with Lactated Ringer’s Irrigation. Class Reactions Adverse reactions reported with Lactated Ringer’s Irrigation (manufacturer unspecified) are: Fluid absorption manifested by Pulmonary edema, Edema, and Electrolyte disturbances. Though not indicated for intravenous administration, absorption of irrigation fluid into tissue or vasculature through a perforation or open wound is possible. As a result, adverse reactions reported with Lactated Ringer’s solutions with and without Dextrose for intravenous administration may be applicable and include:

  • Hypersensitivity reactions, including Anaphylactic/Anaphylactoid reactions, with 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, Headache, Hyperkalemia
  • Pyrexia Overdose In the event of clinically relevant absorption of irrigation fluid, the patients must be evaluated and corrective measures instituted as appropriate.

    • Warnings and Precautions

    WARNINGS Absorption of large volume of irrigation fluids through a perforation or open wound may result in circulatory overload, cardiac failure, or electrolyte disturbances and acid-base imbalance. Patients and fluid balance should be monitored accordingly. If absorption of clinically relevant amounts of fluid is suspected, the fluid administration should be interrupted, and the patient evaluated for possible adverse consequences. Particularly close monitoring is required in patients with:

  • Severely impaired renal function
  • Impaired cardiac function, or
  • Clinical states in which there is edema with sodium retention as a fluid overload syndrome may develop in these patients following absorption of even small quantities of irrigation fluid. Appropriate therapy should be initiated, as indicated. Lactated Ringer’s Irrigation must not be used when types of electrocautery are used that are not safe and effective when performed in the presence of electrolyte solutions. Excessive volume or pressure during irrigation may cause excessive fluid absorption, undue distention of cavities, and/or disruption of tissue.

    • Drug Interactions

    Drug Interactions If clinically relevant amounts of solution have been absorbed, potential interactions with other agents must be considered, such as: Patients treated with drugs that may increase the risk of sodium and fluid retention, such as corticosteroids and carbenoxolone, may have an increased risk of sodium and fluid retention. Due to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringer’s Irrigation may interfere with the elimination of drugs for which renal elimination is pH dependent:

  • Renal clearance of acidic drugs such as salicylates, barbiturates, and lithium may be increased.
  • Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine), dextroamphetamine (dexamphetamine) sulfate, and fenfluramine (phenfluramine) hydrochloride may be decreased. The risk of hyperkalemia is increased in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium-sparing diuretics (amiloride, spironolactone, triameterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine. Administration of potassium in patients treated with such medications can produce severe and potentially fatal hyperkalemia, particularly in patients with severe renal insufficiency. Absorption of calcium-containing solutions may increase the effects of digitalis and lead to serious or fatal cardiac arrhythmia. In patients treated with thiazide diuretics or vitamin D, the risk of hypercalcemia is increased.

    • Contraindications

    CONTRAINDICATIONS Lactated Ringer’s Irrigation is contraindicated in patients with a known hypersensitivity to Sodium Lactate.

    Pregnancy and Breastfeeding

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

    Nursing Mothers There is no adequate data from the use of Lactated Ringer’s Irrigation in lactating women. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing Lactated Ringer’s Irrigation.

    How Supplied

    HOW SUPPLIED Lactated Ringer’s Irrigation in ARTHROMATIC Plastic Container is available as follows: 2B7487 3000 mL NDC 0338-0137-27 2B7489 5000 mL NDC 0338-0137-29 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.

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.