PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

Container Label

Container Label

LOT

EXP

2B2322

NDC 0338-0117-02

Lactated Ringer’s
Injection USP

250 mL

Each100 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
containerNot 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 unit in moisture barrier
overwrap at room temperature
(25°C/77°F) until ready to use Avoid
excessive heat See insert

Viaflex container
PL 146 plastic

BAXTER Viaflex and PL 146 are trademarks of Baxter International Inc

Baxter
Baxter Healthcare Corporation
DeerfieldIL60015 USA

Made in USA

For product information
1-800-933-0303

LOT

EXP

2B2324

NDC 0338-0117-04

Lactated Ringer’s
Injection USP

1000 mL

Each100 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 containerNot 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 clearRx Only Store unit in moisture
barrier overwrap at room temperature (25°C/77°F)
until ready to use Avoid excessive heat See insert

Viaflex container
PL 146 plastic

BAXTER VIAFLEX and PL 146 are trademarks of Baxter International Inc

For Product Information 1-800-933-0303

Baxter
Baxter Healthcare Corporation
DeerfieldIL60015 USA

Made in Mexico

---

DESCRIPTION SECTION

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

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.

---

WARNINGS SECTION

WARNINGS

Potassium Content

The potassium concentration in Lactated Ringer’s Injection, USP is similar to the concentration in plasma; however, it is insufficient to produce a useful effect in case of severe potassium deficiency. Lactated Ringer’s Injection, USP is not recommended for the treatment of severe hypokalemia.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported with Lactated Ringer’s Injection, USP (see ADVERSE REACTIONS). Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Electrolyte Imbalances

Hyponatremia

Lactated Ringer’s Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury.

The risk of hospital acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Lactated Ringer’s Injection, USP.

The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See PRECAUTIONS, Drug Interactions and Pediatric Use.

Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular, premenopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Lactated Ringer’s Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations.

Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications.

Fluid Overload

Depending on the volume and the rate of infusion, the intravenous administration of Lactated Ringer’s Injection, USP can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema.

Avoid Lactated Ringer’s Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations and acid base balance, as needed and especially during prolonged use.

Hyperkalemia

Potassium-containing solutions, including Lactated Ringer’s Injection, USP, may increase the risk of hyperkalemia.

Patients at increased risk of developing hyperkalemia include those:

•

With conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such as patients with severe renal impairment, acute dehydration, extensive tissue injury or burns, certain cardiac disorders such as congestive heart failure.

•

Treated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS, Drug Interactions). 

Avoid use of Lactated Ringer’s Injection, USP in patients with, or at risk for, hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations.

Alkalosis

Because lactate is metabolized to bicarbonate, administration of Lactated Ringer’s Injection, USP may result in, or worsen, metabolic alkalosis. Avoid intravenous administration of Lactated Ringer’s Injection, USP in patients with alkalosis or at risk for alkalosis.

PRECAUTIONS SECTION

PRECAUTIONS

Patients with Renal Impairment

Administration of Lactated Ringer’s Injection, USP in patients with or at risk of severe renal impairment, may result in hyperkalemia and/or fluid overload (seeWARNINGS). Avoid Lactated Ringer’s Injection, USP in patients with severe renal impairment or conditions that may cause sodium and/or potassium retention, fluid overload, or edema. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions

Patients with Hepatic Impairment

In patients with severe hepatic impairment, lactate metabolism may be impaired and Lactated Ringer’s Injection, USP may not produce alkalization. Consider when monitoring serum lactate levels.

Hypercalcemia

Lactated Ringer’s Injection, USP contains calcium salts and may cause hypercalcemia. Avoid administration of Lactated Ringer’s Injection, USP in patients with hypercalcemia or conditions predisposing to hypercalcemia; and in patients with calcium renal calculi or history of such calculi.

Hyperglycemia

Avoid administration of solutions containing lactate in patients with impaired glucose tolerance and diabetes mellitus, as it may result in hyperglycemia.

Monitoring of Serum Lactate Levels

Administration of Lactated Ringer’s Injection, USP may result in an iatrogenic increase in serum lactate levels and interfere with interpretation of serum lactate levels in patients with severe metabolic acidosis including lactic acidosis.

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.

Administration of a lactate-containing intravenous solution to infants should take into account that the liver and kidneys are still maturing during the first year of life, which also affects the biotransformation and renal excretion of lactate.

Pediatric patients are at increased risk of developing hyponatremia as well as for developing encephalopathy as a complication of hyponatremia (see WARNINGS**)**.

Geriatric Use

Geriatric patients are at increased risk of developing electrolyte imbalances. Lactated Ringer's Injection, USP 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. Therefore, 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. Consider monitoring renal function in elderly patients.

Drug Interactions

Ceftriaxone

For information on interaction with ceftriaxone – see CONTRAINDICATIONS.

Other Drugs that Increase the Risk of Hyponatremia

Administration of Lactated Ringer’s Injection, USP to patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.

Avoid use of Lactated Ringer’s Injection, USP in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic medications. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

Other Products that Affect Fluid and/or Electrolyte Balance

Administration of Lactated Ringer’s Injection, USP to patients treated concomitantly with drugs associated with sodium and fluid retention may increase the risk of hypernatremia and volume overload. Avoid use of Lactated Ringer’s Injection, USP in patients receiving such products, such as corticosteroids or corticotropin. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance.

Other Products that Cause Hyperkalemia

Administration of Lactated Ringer’s Injection, USP to patients treated concurrently or recently with products that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia.

Avoid use of Lactated Ringer’s Injection, USP to patients receiving such products (e.g., potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine). If use cannot be avoided, monitor serum potassium concentrations.

Lithium

Renal sodium and lithium clearance may be increased during administration of Lactated Ringer’s Injection, USP and result in decreased lithium concentrations. Avoid use of Lactated Ringer’s Injection, USP in patients receiving lithium. If use cannot be avoided, monitor serum lithium concentrations during concomitant use.

Digoxin

Administration of calcium may increase the effects of digitalis and lead to serious or fatal cardiac arrhythmia. In patients treated with digoxin, consider reducing the volume, and/or rate of administration of Lactated Ringer’s Injection, USP.

Other Drugs that Increase the Risk of Hypercalcemia

Avoid Lactated Ringer’s Injection, USP in patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.

Drugs with pH Dependent Renal Elimination

Due to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringer’s Injection, USP may interfere with the elimination of drugs with pH dependent renal elimination. Renal clearance of acidic drugs may be increased. Renal clearance of alkaline drugs may be decreased.

Pregnancy

Teratogenic Effects

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 SECTION

ADVERSE REACTIONS

Post-Marketing Adverse Reactions

The following adverse reactions associated with the use of Lactated Ringer’s Injection, USP were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

Hypersensitivity and infusion reactions: 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, laryngeal edema and sneezing, infection at the site of injection, extravasation and infusion site anesthesia (numbness).

Metabolism and Nutrition Disorders: hyperkalemia, hyponatremia, hypervolemia.

General Disorders and Administration Site Conditions: phlebitis, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning.

Nervous System Disorders: hyponatremic encephalopathy.

---

HOW SUPPLIED SECTION

HOW SUPPLIED

Lactated Ringer’s Injection, USP 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 (25°C); brief exposure up to 40°C does not adversely affect the product.

---