Sodium Lactate

Baxter Healthcare Corporation

Sodium Lactate Injection, USP (M/6 Sodium Lactate)in VIAFLEX Plastic Container

FULL PRESCRIBING INFORMATION: CONTENTS*

• SODIUM LACTATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• SODIUM LACTATE INDICATIONS AND USAGE
• SODIUM LACTATE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pediatric Use
  • Geriatric Use
  • Drug Interactions
  • Pregnancy
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Labor and Delivery
  • Nursing Mothers
• SODIUM LACTATE ADVERSE REACTIONS
  • Post-Marketing Adverse Reactions
  • Class Reactions
  • Overdose
• SODIUM LACTATE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER
  • To Open
  • Preparation for Administration
  • To Add Medication
• Package Label-Principle Display Panel

FULL PRESCRIBING INFORMATION

SODIUM LACTATE DESCRIPTION

Sodium Lactate Injection, USP (M/6 Sodium Lactate) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. It contains no antimicrobial agents. The pH may have been adjusted with lactic acid. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

Table 1

	Size (mL)	Composition (g/L)	Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.Osmolarity (mOsmol/L) (calc)	pH	Ionic Concentration (mEq/L)		Caloric Content (kcal/L)
		Sodium Lactate (C3H5NaO3)			Sodium	Lactate
Sodium Lactate Injection, USP (M/6 Sodium Lactate)	500	18.7	334	6.5 (6.0 to 7.3)	167	167	54
	1000

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). 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 plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Sodium Lactate Injection, USP has value as a source of water, electrolytes, and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

Sodium Lactate Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

SODIUM LACTATE INDICATIONS AND USAGE

Sodium Lactate Injection, USP is indicated as a source of water, electrolytes, and calories or as an alkalinizing agent.

SODIUM LACTATE CONTRAINDICATIONS

Sodium Lactate Injection, USP is contraindicated in patients with a known hypersensitivity to sodium lactate.

WARNINGS

Sodium Lactate Injection, USP is not for use for the treatment of lactic acidosis or severe metabolic acidosis.

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.

Depending on the volume and rate of infusion, the intravenous administration of these injections 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 injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.

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.

Excessive administration of Sodium Lactate Injection, USP may result in hypokalemia.

Sodium Lactate 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.

Sodium Lactate 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 retention, fluid overload, or edema.

PRECAUTIONS

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.

Sodium Lactate 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 Sodium Lactate Injection, USP may not produce its alkalinizing action in patients with severe hepatic insufficiency, since lactate metabolism may be impaired. Lactate is a substrate for gluconeogenesis. This should be taken into account when Sodium Lactate Injection, USP is used in patients with type 2 diabetes.

Pediatric Use

Safety and effectiveness of Sodium Lactate Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of sodium lactate 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 Sodium Lactate 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

Caution is advised when administering Sodium Lactate 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 Sodium Lactate Injection USP to patients treated with drugs for which renal elimination is pH dependent. Due to the alkalinizing action of lactate (formation of bicarbonate), Sodium Lactate 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 Sodium Lactate Injection, USP to patients treated with lithium.

Pregnancy

Teratogenic Effects 

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Lactate Injection, USP. It is also not known whether Sodium Lactate Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Lactate Injection, USP should be given to a pregnant woman only if clearly needed.

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 Sodium Lactate 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 Sodium Lactate 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 Sodium Lactate Injection, USP is administered to a nursing mother.

SODIUM LACTATE ADVERSE REACTIONS

Post-Marketing Side Effects

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 manifested by: blood pressure decreased, pyrexia
General Disorders and Administration Site Conditions:
Infusion site burning

Class Reactions

Other symptoms of hypersensitivity/infusion reactions: anaphylactic/anaphylactoid reactions, and the following manifestations: angioedema, chest pain, chest discomfort, decreased heart rate, tachycardia, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthaesias, hypesthesia oral, dysgeusia, nausea, anxiety and headache

Hypervolemia

Infusion site reactions, including infection at the site of injection, phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site anesthesia (numbness)

Overdose

An excessive volume or too high a rate of administration of Sodium Lactate 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.

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.

SODIUM LACTATE 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, patient's age, weight, concomitant treatment and clinical condition of the patient as well as laboratory determinations.

All injections in VIAFLEX 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 Sodium Lactate 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 Sodium Lactate 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 Sodium Lactate 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

Sodium Lactate Injection, USP (M/6 Sodium Lactate) in VIAFLEX plastic container is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25ºC); brief exposure up to 40ºC does not adversely affect the product.

DIRECTIONS FOR USE OF VIAFLEX 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

• Suspend container from eyelet support.
• Remove protector from outlet port at bottom of container.
• Attach administration set. Refer to complete directions accompanying set.

To Add Medication

To add medication before solution administration

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

• Close clamp on the set.
• Prepare medication site.
• Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
• Remove container from IV pole and/or turn to an upright position.
• Evacuate both ports by squeezing them while container is in the upright position.
• Mix solution and medication thoroughly.
• Return container to in use position and continue administration.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

07-19-72-481

Rev. November 2013

BAXTER, VIAFLEX, and PL 146 are trademarks of
Baxter International Inc.

Package Label-Principle Display Panel

FOR HI-RES INK JET

2B1804X

14-1000 ML
VIAFLEX CONTAINER

SODIUM LACTATE INJECTION, USP
M/6 SODIUM LACTATE

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380129046