Lactated Ringer’s Irrigation Solution

Generic Name: SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE
Brand Name: Lactated Ringers Irrigation
  • Substance Name(s):
  • SODIUM CHLORIDE
  • POTASSIUM CHLORIDE
  • CALCIUM CHLORIDE
  • SODIUM LACTATE

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).

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 (CH3CH(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 (CaCl2 • 2H2O), 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 C3H5NaO3, a 60% aqueous solution miscible in water.

It has the following structural formula: Water for Injection, USP is chemically designated H2O.

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).

INDICATIONS AND USAGE

Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

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.

PREGNANCY

Pregnancy Category C 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.

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 .)