LACTATED RINGERS sodium chloride potassium calcium injection solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)
Available from:
Baxter Healthcare Corporation
INN (International Name):
SODIUM CHLORIDE
Composition:
SODIUM CHLORIDE 600 mg in 100 mL
Prescription type:
PRESCRIPTION DRUG
Authorization status:
New Drug Application

LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, calcium

chloride injection, solution

Baxter Healthcare Corporation

----------

Lactated Ringer’s Injection, USP

in AVIVA Plastic Container

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.

Table 1

Size

(mL)

Composition (g/L)

Osmolarity

(mOsmol/L)

(calc)

nominal

(range)

Ionic Concentration (mEq/L)

Caloric

Content

(kcal/L)

Sodium

Chloride,

USP,

(NaCl)

Sodium

Lactate,

(C H NaO )

Potassium

Chloride,

USP,

(KCl)

Calcium

Chloride,

(CaCl

·2H O)

SodiumPotas s ium CalciumChloride Lactate

Lactated

Ringer’s

Injection,

(6.0 to

7.5)

4

1000

The flexible container is made with non-latex plastic materials specially designed for a wide range of

parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene.

For example, the AVIVA container system is compatible with and appropriate for use in the admixture

and administration of paclitaxel. In addition, the AVIVA container system is compatible with and

appropriate for use in the admixture and administration of all drugs deemed compatible with existing

polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or

other plasticizers.

The suitability of the container materials has been established through biological evaluations, which

have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers.

These tests confirm the biological safety of the container system.

The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The

container does not require entry of external air during administration.

The container has two ports: one is the administration outlet port for attachment of an intravenous

administration set and the other port has a medication site for addition of supplemental medication (See

DIRECTIONS FOR USE OF AVIVA PLASTIC CONTAINER). The primary function of the overwrap

is to protect the container from the physical environment.

CLINICAL PHARMACOLOGY

Lactated Ringer’s Injection, USP 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, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized

ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

INDICATIONS AND USAGE

Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing

agent.

CONTRAINDICATIONS

As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and

Lactated Ringer’s Injection, USP 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, USP, 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, USP is contraindicated in patients with a known hypersensitivity to sodium

lactate.

WARNINGS

Although Lactated Ringer’s Injection, USP has a potassium concentration similar to the concentration in

plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency; therefore, it

should not be used for this purpose.

Lactated Ringer’s Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic

acidosis.

Lactated Ringer’s Injection, USP should not be administered simultaneously with citrate

anticoagulated/preserved blood through the same administration set because of the likelihood of

coagulation.

The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity

reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Hypersensitivity reactions are reported more frequently during pregnancy.

Depending on volume and rate of infusion, the intravenous administration of Lactated Ringer’s Injection,

USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations,

overhydration, congested states, pulmonary edema or acid-base imbalance. The risk of dilutional states

is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload

causing congested states with peripheral and pulmonary edema is directly proportional to the

electrolyte concentrations of the injections.

Clinical evaluation and periodic laboratory determinations may be necessary to monitor changes in fluid

balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or

whenever the condition of the patient or the rate of administration warrants such evaluation.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with

hyperkalemia or conditions predisposing to hyperkalemia (such as severe renal impairment or

adrenocortical insufficiency, acute dehydration, or extensive tissue injury or burns) and in patients with

cardiac disease.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with

alkalosis or at risk for alkalosis. Because lactate is metabolized to bicarbonate, administration may

result in, or worsen, metabolic alkalosis.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with

severe renal impairment, hypervolemia, overhydration, or conditions that may cause sodium and/or

potassium retention, fluid overload, or edema.

PRECAUTIONS

General

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible

residual air contained in the primary container.

Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can

result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air

embolism. Vented intravenous administration sets with the vent in the open position should not be used

with flexible plastic containers.

Lactated Ringer’s Injection, USP should be administered with particular caution, if at all, to patients with

conditions associated with increased lactate levels or impaired lactate utilization, such as severe

hepatic insufficiency.

Hyperlactatemia can develop in patients with severe hepatic insufficiency, since lactate metabolism may

be impaired. In addition Lactated Ringer’s Injection, USP may not produce its alkalinizing action in

patients with severe hepatic insufficiency, since lactate metabolism may be impaired.

Solutions containing calcium salts should be used with caution in patients with hypercalcemia or

conditions predisposing to hypercalemia, such as patients with severe renal impairment and

granulomatous diseases associated with increased calcitriol synthesis such as sarcoidosis, calcium

renal calculi or history of such calculi.

Lactate is a substrate for gluconeogenesis. This should be taken into account when Lactated Ringer’s

Injection, USP is used in patients with type 2 diabetes.

Pediatric Use

Safety and effectiveness of Lactated Ringer’s Injection, USP in pediatric patients have not been

established by adequate and well controlled trials, however, the use of electrolyte solutions in the

pediatric population is referenced in the medical literature. The warnings, precautions and adverse

reactions identified in the label copy should be observed in the pediatric population.

Lactate-containing solutions should be administered with particular caution to neonates and infants less

than 6 months of age.

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 the 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.

Drug Interactions

Ceftriaxone – see CONTRAINDICATIONS

Caution is advised when administering Lactated Ringer’s Injection, USP 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, USP 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, USP 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, USP to patients treated with lithium.

Because of its potassium content, Lactated Ringer’s Injection, USP 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, USP to patients treated with thiazide

diuretics or vitamin D, as these can increase the risk of hypercalcemia.

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 Lactated Ringer’s Injection, USP can cause fetal harm when administered to a

pregnant woman or can affect reproduction capacity. Lactated Ringer’s Injection, USP should be given

to a pregnant woman only if clearly needed.

For Hypersensitivity Reactions During Pregnancy – see WARNINGS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic

potential have not been performed with Lactated Ringer’s Injection, USP. Studies to evaluate the

possible impairment of fertility have not been performed.

Labor and Delivery

Studies have not been conducted to evaluate the effects of Lactated Ringer’s Injection, USP on labor

and delivery. Caution should be exercised when administering this drug during labor and delivery.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human

milk, caution should be exercised when Lactated Ringer’s Injection, USP is administered to a nursing

mother.

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, paresthesias, 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)

Overdos e

An excessive volume or too high a rate of administration of Lactated Ringer’s Injection, USP 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.

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 AVIVA 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, USP, 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, USP. 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, USP 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.

HOW SUPPLIED

Lactated Ringer’s Injection, USP in AVIVA plastic container is available as follows:

Code

Size (mL)

NDC

6E2322

0338-6307-02

6E2323

0338-6307-03

6E2324

1000

0338-6307-04

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.

DIRECTIONS FOR USE OF AVIVA PLASTIC CONTAINER

For Information on Risk of Air Embolism - see PRECAUTIONS

To Open

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the

outlet port protector is damaged, detached, or not present, discard container as solution path sterility

may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process

may be observed. This is normal and does not affect the solution quality or safety. The opacity will

diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard

solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration

1. Suspend container from eyelet support.

2. Remove protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

To add medication before solution administration

1. Prepare medication site.

2. Using syringe with 19 to 22 gauge needle, puncture medication port and inject.

3. Mix solution and medication thoroughly. For high density medication such as potassium chloride,

squeeze ports while ports are upright and mix thoroughly.

To add medication during solution administration

1. Close clamp on the set.

2. Prepare medication site.

3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by squeezing them while container is in the upright position.

6. Mix solution and medication thoroughly.

7. Return container to in use position and continue administration.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

07-19-72-480

Rev. November 2013

Baxter and AVIVA are trademarks of

Baxter International Inc.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

250 mL

6E2322

NDC 0338-6307-02

Lactated Ringer's

Injection USP

EACH 100 mL CONTAINS 600 mg SODIUM

CHLORIDE USP 310 mg SODIUM LACTATE

30 mg POTASSIUM CHLORIDE USP

20 mg CALCIUM CHLORIDE USP pH 6.5 (6.0

TO 7.5) mEq/L SODIUM 130 POTASSIUM

4 CALCIUM 2.7 CHLORIDE 109 LACTATE

28 OSMOLARITY 273 mOsmol/L (CALC)

STERILE NONPYROGENIC SINGLE DOSE

CONTAINER NOT FOR USE IN THE TREATMENT

OF LACTIC ACIDOSIS ADDITIVES MAY BE

INCOMPATIBLE CONSULT WITH PHARMACIST

IF AVAILABLE WHEN INTRODUCING ADDITIVES

USE ASEPTIC TECHNIQUE MIX THOROUGHLY

DO NOT STORE DOSAGE INTRAVENOUSLY

AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS

CAUTIONS SQUEEZE AND INSPECT INNER BAG

WHICH MAINTAINS PRODUCT STERILITY DISCARD

IF LEAKS ARE FOUND MUST NOT BE USED IN

SERIES CONNECTIONS DO NOT ADMINISTER

SIMULTANEOUSLY WITH BLOOD DO NOT USE

UNLESS SOLUTION IS CLEAR Rx ONLY STORE

AT ROOM TEMPERATURE (25°C/77°F) UNTIL

READY TO USE AVOID EXCESSIVE HEAT

SEE INSERT

Baxter

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 6001 USA

MADE IN USA

BAXTER AVIVA AND THE AVIVA

CRESCENT DESIGN ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION

1-800-933-0303

AVIVA CONTAINER

6E2322

40-250 ML

AVIVA CONTAINER

LACTATED RINGER'S INJECTION, USP

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

XXXXX

PRIMARY BAR CODE

(01) 50303386307028

LACTATED RINGERS

sodium chloride, sodium lactate, potassium chloride, calcium chloride injection, solution

Baxter Healthcare Corporation

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 338 -6 30 7

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (SODIUM CATION - UNII:LYR4M0 NH37, CHLORIDE

ION - UNII:Q32ZN48 6 9 8 )

SODIUM

CHLORIDE

6 0 0 mg

in 10 0 mL

SO DIUM LACTATE (UNII: TU7HW0 W0 QT) (SODIUM CATION - UNII:LYR4M0 NH37, LACTIC

ACID - UNII:33X0 4XA5AT)

SODIUM

LACTATE

310 mg

in 10 0 mL

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 ) (POTASSIUM CATION - UNII:29 5O53K152,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

POTASSIUM

CHLORIDE

30 mg

in 10 0 mL

CALCIUM CHLO RIDE (UNII: M4I0 D6 VV5M) (CALCIUM CATION - UNII:2M8 3C4R6 ZB,

CHLORIDE ION - UNII:Q32ZN48 6 9 8 )

CALCIUM

CHLORIDE

20 mg

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 338 -6 30 7-0 2

250 mL in 1 BAG

2

NDC:0 338 -6 30 7-0 3

50 0 mL in 1 BAG

3

NDC:0 338 -6 30 7-0 4

10 0 0 mL in 1 BAG

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 16 6 8 2

0 3/22/19 71

Labeler -

Baxter Healthcare Corporation (005083209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Baxter Healthcare

Co rpo ra tio n

0 59 140 76 4

ANALYSIS(0 338 -6 30 7) , MANUFACTURE(0 338 -6 30 7) , LABEL(0 338 -6 30 7) ,

PACK(0 338 -6 30 7) , STERILIZE(0 338 -6 30 7)

Revised: 4/2014

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