Lactated Ringers Irrigation
Sodium chloride, sodium lactate, potassium chloride and calcium chloride · Solution · Irrigation
Uses
Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Dosage and administration
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the manufacturer’s recommendations should be followed. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. (See PRECAUTIONS .)
Contraindications
CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Warnings
WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus this irrigation must be regarded as a systemic drug. Absorption of large amounts 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not warm container over 150°F (66°C).
Precautions
Do not use for irrigation that may result in absorption into the blood. Caution should be observed when the solution is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of circulatory overload. Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. Do not administer unless solution is clear and container is undamaged. Discard unused portion. Pregnancy Animal reproduction studies have not been conducted with Lactated Ringer’s Irrigation. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. Pediatric Use The safety and effectiveness of Lactated Ringer’s Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Side effects
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with Lactated Ringer’s Irrigation. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Pediatric use
Pediatric Use The safety and effectiveness of Lactated Ringer’s Irrigation have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.
Overdosage
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .)
Description
Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na + ) 130; potassium (K + ) 4; calcium (Ca ++ ) 3; chloride (Cl¯) 109 and lactate (CH 3 CH(OH)COO¯) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostatic or antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portion should be discarded. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl 2
• 2H 2 O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated C 3 H 5 NaO 3 , a 60% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 O. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP. Structural Formula
How supplied
Lactated Ringer's Irrigation is supplied sterile and nonpyrogenic in single-dose 3000 mL flexible irrigation container packaged 4 per case. NDC REF Size 0264-7389-60 R8306 3000 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C does not adversely affect the product. Do not warm container over 150°F (66°C).
Label text from the FDA structured product label by B. Braun Medical Inc. (revised Aug 6, 2021). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Chloride in 1 product
- Sodium Lactate in 1 product
- Potassium Chloride in 1 product
- Calcium Chloride in 1 product
Lactated Ringers Irrigation NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0264-7389 | Sodium Chloride 600 mg/100mL; Sodium Lactate 310 mg/100mL; Potassium Chloride 30 mg/100mL; Calcium Chloride 20 mg/100mL Solution | B. Braun Medical Inc. | NDA |
Lactated Ringers Irrigation recalls
- D-0498-2026 Apr 29, 2026 · Class II · Ongoing
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Frequently asked questions
What is Lactated Ringers Irrigation used for?
Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
What are the side effects of Lactated Ringers Irrigation?
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of… See the full label for the complete list.
Who makes Lactated Ringers Irrigation?
Lactated Ringers Irrigation is listed by 1 labeler in the FDA NDC directory, including B. Braun Medical Inc..
Has Lactated Ringers Irrigation been recalled?
The FDA enforcement database lists 1 recall for Lactated Ringers Irrigation, most recently D-0498-2026 (class ii): Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.