Get your patient on Lactated Ringers - Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride injection, Solution (Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride)
Lactated Ringers - Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride injection, Solution prescribing information
INDICATIONS AND USAGE:
Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent.
DOSAGE AND ADMINISTRATION:
As directed by a physician. Dosage, rate and duration of administration are to be individualized and dependent upon the indication for use, the patient's age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.
All injections in flexible plastic containers are intended for intravenous administration using sterile and nonpyrogenic equipment.
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers.
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 seal is intact.
When making additions to Lactated Ringer's Injection, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.
Additives may be incompatible with Lactated Ringer's Injection. As with all parenteral solutions, compatibility of the additives with the solution must be assessed before addition, by checking for 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 Injection is appropriate.
The instructions for use of the medication to be added and other relevant literature must be consulted. Additives known or determined to be incompatible should not be used.
CONTRAINDICATIONS:
As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Lactated Ringer's Injection is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream).
In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Lactated Ringer's Injection, through the same infusion line (e.g., via Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.
Lactated Ringer's Injection is contraindicated in patients with a known hypersensitivity to sodium lactate.
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.
Drug Interactions
Ceftriaxone (see CONTRAINDICATIONS ).
Caution is advised when administering Lactated Ringer's Injection 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 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 may interfere with the elimination of such drugs.
- Renal clearance of acidic drugs such as salicylates and barbiturates may be increased.
- Renal clearance of alkaline drugs, such as sympathomimetics (e.g., ephedrine, pseudoephedrine) and dextroamphetamine (dexamphetamine) sulfate, may be decreased.
Renal clearance of lithium may also be increased. Caution is advised when administering Lactated Ringer's Injection to patients treated with lithium.
Because of its potassium content, Lactated Ringer's Injection 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 to patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.
DESCRIPTION:
Lactated Ringer's Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 .
| Size (mL) | Composition (g/L) | Ionic Composition (mEq/L) | Caloric Content (kcal/L) | ||||||||||
| Sodium Chloride, USP (NaCl) | Sodium Lactate, USP (C 3 H 5 NaO 3 ) | Potassium Chloride, USP (KCl) | Calcium Chloride, USP (CaCl 2 •2H 2 O) | Osmolarity (mOsmol/L) (calc) | pH | Sodium | Potassium | Calcium | Chloride | Lactate | |||
| Lactated Ringer's Injection, USP | 250 | 6 | 3.1 | 0.3 | 0.2 | 273 | 6.5 (6.0 to 7.5) | 130 | 4 | 2.7 | 109 | 28 | 9 |
| 500 | |||||||||||||
| 1,000 | |||||||||||||
The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). 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 flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.
CLINICAL PHARMACOLOGY:
Lactated Ringer's Injection 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 produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.
HOW SUPPLIED:
Lactated Ringer's Injection, USP in a single dose flexible plastic container, is available as follows:
| Product | Each | Unit of Sale |
| 1727171005 | NDC 17271-710-05 One 250 mL free flex ® Bag | NDC 17271-710-05 Sold in units of 30 |
| 1727171006 | NDC 17271-710-06 One 500 mL free flex ® Bag | NDC 17271-710-06 Sold in units of 20 |
| 1727171007 | NDC 17271-710-07 One 1,000 mL free flex ® Bag | NDC 17271-710-07 Sold in units of 10 |
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.
STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product.
The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
INSTRUCTIONS FOR USE:
Check flexible container solution composition, lot number, and expiry date.
Do not remove solution container from its overwrap until immediately before use.
Use sterile equipment and aseptic technique.
To Open
- Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container.
- Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
Preparation for Administration
- Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container.
- Use a non-vented infusion set or close the air-inlet on a vented set.
- Close the roller clamp of the infusion set.
- Hold the base of BLUE Infusion Port.
- Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set.
To Add Medication Prior to Solution Administration
- Identify WHITE Additive Port with arrow pointing toward container.
- Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container.
- Hold base of WHITE Additive Port horizontally.
- Prepare medication site.
- Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives.
- Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
To Add Medication During Solution Administration
- Close the clamp on the set.
- Identify WHITE Additive Port with arrow pointing toward container.
- Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port Cap with the arrow pointing toward container.
- Hold base of WHITE Additive Port horizontally.
- Prepare medication site.
- Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives.
- Remove container from IV pole and/or turn to an upright position.
- Mix container contents thoroughly.
- Using aseptic technique, repeat steps 4-7 as necessary.
- Return container to in use position and continue administration.
WARNING: Do not use flexible container in series connections.
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 USA For product inquiry: 1-800-523-0502 Distributed by BD Manufactured by Fresenius Kabi.
Revised: January 2024
