Lactated Ringer’s Injection, USP

lactated ringer's (Sodium chloride, sodium lactate, potassium chloride, and calcium chlorideinjection, solution 
[Hospira, Inc.]

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DESCRIPTION

Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution containing isotonic concentrations of electrolytes in water for injection. It is administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes.

Each 100 mL of Lactated Ringer’s Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl) 109 mEq and lactate [CH3CH(OH) COO] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 to 7.5).

This solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.

Lactated Ringer’s Injection, USP is a parenteral fluid, nutrient and/or electrolyte replenisher.

Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2• 2 H2O), 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 monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water.

It has the following structural formula:

Image from Drug Label Content

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a clear multilayer plastic film (FC97). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

CLINICAL PHARMACOLOGY

When administered intravenously, these solutions provide sources of water and electrolytes. Their electrolyte content resembles that of the principal ionic constituents of normal plasma and the solutions therefore are suitable for parenteral replacement of extracellular losses of fluid and electrolytes.

Calcium chloride in water dissociates to provide calcium (Ca++) and chloride (Cl) ions. They are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.

Potassium chloride in water dissociates to provide potassium (K+) and chloride (Cl) ions. Potassium is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). It is the chief cation of body cells (160 mEq/liter of intracellular water). Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output.

Sodium lactate provides sodium (Na+) and lactate (C3H5O3) ions. The lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. In the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. The sodium (Na+) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). The normal plasma level of lactate ranges from 0.9 to 1.9 mEq/liter.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS AND USAGE

These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, as required bythe clinical condition of the patient.

CONTRAINDICATIONS

Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

WARNINGS

Solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation.

Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency.

The intravenous administration of these solutions 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.

PRECAUTIONS

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.

Potassium containing solutions should be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.

Solutions containing lactate ions should be used with caution as excess administration may result in metabolic alkalosis.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Pregnancy:

Teratogenic effects

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

Pediatric Use:

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

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 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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

DOSAGE AND ADMINISTRATION

The dose is dependent upon the age, weight and clinical condition of the patient.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

The presence of calcium limits their compatibility with certain drugs that form precipitates of calcium salts, and also prohibits their simultaneous infusion through the same administration set as blood because of the likelihood of coagulation.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

INSTRUCTIONS FOR USE

Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

(Use aseptic technique)

  1. Remove blue cap from sterile medication additive port at bottom of container.

  2. With a needle of appropriate length, puncture resealable additive port and inject. Withdraw needle after injecting medication.

  3. Mix container contents thoroughly.

  4. The additive port may be protected by an appropriate cover.

Preparation for Administration

(Use aseptic technique)

NOTE: See appropriate I.V. administration set Instructions for Use.

  1. Close flow control clamp of administration set.

  2. Remove cap from sterile administration set port at bottom of container.

  3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

  4. Suspend container.

  5. Squeeze and release drip chamber to establish proper fluid level in chamber.

  6. Open clamp. Eliminate air from remainder of set.

  7. Attach set to patient access device.

  8. Begin infusion.

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

HOW SUPPLIED

Lactated Ringer’s Injection, USP is supplied in single-dose flexible plastic containers as follows:

 List No.

Product Name

Container Size (mL)

 7953

Lactated Ringer’s

Injection, USP

500 & 1000

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

U.S. patent 4,344,472

May, 2006

©Hospira 2006 EN-1201Printed in USA
Hospira, Inc., Lake Forest, IL 60045 USA

Lactated Ringer's (Sodium chloride, sodium lactate, potassium chloride, and calcium chloride)
PRODUCT INFO
Product Code0409-7953Dosage FormINJECTION, SOLUTION
Route Of AdministrationINTRAVENOUSDEA Schedule
INGREDIENTS
Name (Active Moiety)TypeStrength
Sodium Chloride (Sodium Chloride) Active600 MILLIGRAM  In 100 MILLILITER
Sodium Lactate (Sodium Lactate) Active310 MILLIGRAM  In 100 MILLILITER
Potassium Chloride (Potassium Chloride) Active30 MILLIGRAM  In 100 MILLILITER
Calcium Chloride (Calcium Chloride) Active20 MILLIGRAM  In 100 MILLILITER
Hydrochloric AcidInactive 
Sodium HydroxideInactive 
WaterInactive 
IMPRINT INFORMATION
CharacteristicAppearanceCharacteristicAppearance
ColorScore
ShapeSymbol
Imprint CodeCoating
Size
PACKAGING
#NDCPackage DescriptionMultilevel Packaging
10409-7953-3024 BAG In 1 CASEcontains a BAG
1500 MILLILITER In 1 BAGThis package is contained within the CASE (0409-7953-30)
20409-7953-4812 BAG In 1 CASEcontains a BAG
21000 MILLILITER In 1 BAGThis package is contained within the CASE (0409-7953-48)

Revised: 03/2007