LACTATED RINGERS- sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution

Lactated Ringers by

Drug Labeling and Warnings

Lactated Ringers by is a Prescription medication manufactured, distributed, or labeled by B. Braun Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Lactated Ringer’s Injection is indicated for use as a source of water and electrolytes or as an alkalinizing agent in adults and pediatric patients.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Dosage Considerations

    The recommended dosage and duration of Lactated Ringer’s Injection is directed by a physician based on the patient’s age, weight, clinical condition, and concomitant therapy.  Evaluate the patient’s clinical status and monitor changes in electrolyte concentrations especially during prolonged use of Lactated Ringer’s Injection to optimize clinical status.

    2.2 Important Preparation Instructions

    Visually inspect the Lactated Ringer’s Injection solution for particulate matter and discoloration.  Do not administer Lactated Ringer’s Injection unless the solution is clear and the container and seals are intact.

    If additives are determined to be compatible with Lactated Ringer’s Injection then using aseptic technique, mix thoroughly; do not store solutions containing additives. After mixing, do not use if there is discoloration or formation of precipitates.

    To reduce the risk of air embolism, adhere to the following Lactated Ringer’s Injection preparation instructions [see Warnings and Precautions (5.2)]:

    • Use a non-vented infusion set or close the vent on a vented set.
    • Use a dedicated line without any connections (do not connect flexible containers in series).
    • The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. If using a pumping device to administer Lactated Ringer’s Injection, turn off the pump before the container is empty.

    Preparation Instructions for EXCEL® Plus Container

    1. Tear overwrap down at notch and remove solution container.
    2. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration [see Dosage and Administration (2.3)].
    3. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
    4. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.

    Preparation for Administration

    1. Remove foil cover from sterile set port at bottom of container as shown in Figure A, Steps 1 and 2.

    Figure A - Step 1Figure A - Step 2

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

    2.3 Important Administration Instructions

    Lactated Ringer’s Injection is for intravenous use.

    Use immediately after opening the container. Discard the unused portion.

    Some additives may be incompatible [see Dosage and Administration (2.4)].

    To Add Medication Before Solution Administration
     1. Prepare medication site.
    2. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject.
    3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

    To Add Medication During Solution Administration
     1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by tapping and 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.

    2.4 Drug Incompatibilities

    Do not administer Lactated Ringer’s Injection simultaneously with ceftriaxone via a Y-site in neonates due to serious risks [see Contraindications (4) and Warnings and Precautions (5.1)]. However, in patients older than 28 days, ceftriaxone and Lactated Ringer’s Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Warnings and Precautions (5.1)].

    Do not administer Lactated Ringer’s Injection simultaneously with citrate anticoagulated/preserved blood through the same administration set because of the likelihood of coagulation precipitated by the calcium content of Lactated Ringer’s Injection.

  • 3 DOSAGE FORMS AND STRENGTHS

    Injection: Lactated Ringer’s Injection as a clear, sterile, and nonpyrogenic solution packaged in
    single-dose containers: 500 mL and 1,000 mL.

  • 4 CONTRAINDICATIONS

    Lactated Ringer’s Injection is contraindicated in:

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Serious Risk with Concomitant Use with Ceftriaxone

    Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as Lactated Ringer’s Injection, in the same intravenous administration line.  Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used:

    Lactated Ringer’s Injection is contraindicated in neonates who receive ceftriaxone [see Contraindications (4), Use in Specific Populations (8.4)]. However, in patients older than 28 days, ceftriaxone and Lactated Ringer’s Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

    5.2 Air Embolism

    Cases of air embolism have been reported with pressurized administration of intravenous fluids. Air embolism may result in stroke, organ ischemia and/or infarction, and death.

    Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. If administration is controlled by a pumping device, care must be taken to discontinue the pumping action before the container is empty.

    Pressure infusion is not recommended to increase flow rates, but if necessary, ensure all air is removed from the bag before infusion.

    Refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container [see Dosage and Administration (2.2)].

    5.3 Hypersensitivity Reactions

    Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Lactated Ringer’s Injection. Stop the Lactated Ringer’s Injection infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

    5.4 Potassium Imbalances

    Hyperkalemia

    Potassium-containing solutions, including Lactated Ringer’s Injection, may increase the risk of hyperkalemia. This risk is increased in patients predisposed to hyperkalemia including those with severe renal impairment, acute dehydration, extensive tissue injury or burns, heart failure, or in those using concomitant drugs that are associated with hyperkalemia.

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

    Hypokalemia

    The potassium concentration in Lactated Ringer’s Injection is similar to the concentration in plasma. It is insufficient to normalize the serum potassium in patients with severe hypokalemia.

    5.5 Hyponatremia

    Lactated Ringer’s Injection may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs, or certain antiepileptic, psychotropic, or cytotoxic drugs) [see Drug Interactions (7.1), Use in Specific Populations (8.4)].

    Avoid Lactated Ringer’s Injection in patients with or at risk for hyponatremia. If use cannot be avoided in these patients, closely monitor serum sodium concentrations.

    Rapid correction of hyponatremia may result in serious neurologic complications such as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status.

    5.6 Hypercalcemia

    Lactated Ringer’s Injection contains calcium salts and may cause hypercalcemia. Avoid administration of Lactated Ringer’s Injection in patients with hypercalcemia, those with calcium-containing renal calculi or history of such calculi, those with conditions predisposing to hypercalcemia, or treated with concomitant thiazide diuretics or vitamin D.

    5.7 Fluid Overload

    Depending on the administered volume and the infusion rate, administration of Lactated Ringer’s Injection can cause fluid overload, including pulmonary edema.

    Avoid Lactated Ringer’s Injection in patients at risk for fluid and/or solute overload including patients with severe renal impairment. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations and acid base balance, especially during prolonged use.

    5.8 Acid/Base Imbalances

    Because lactate is metabolized to bicarbonate, administration of Lactated Ringer’s Injection may result in, or worsen, metabolic alkalosis. Closely monitor the acid-base balance in patients with, or at risk of, alkalosis.

    In patients with severe hepatic impairment, decreased lactate metabolism may result in worsening anion gap metabolic acidosis. Avoid Lactated Ringer’s Injection in patients with severe hepatic impairment. If use cannot be avoided in these patients, closely monitor serum bicarbonate levels.

    5.9 Interference of Lactated Ringer’s Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis

    Administration of Lactated Ringer’s Injection may result in interference with the interpretation of serum lactate levels in patients with severe metabolic acidosis. [see Drug Interactions (7.5)].

  • 6 ADVERSE REACTIONS

    The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

    The following adverse reactions have been identified during postapproval use of Lactated Ringer’s Products.   Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

    General Disorders and Administration Site Conditions:

    Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia.

    Hypersensitivity Reactions and Infusion Reactions:

    Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, headache, laryngeal edema, sneezing, and injection site infection.

    Metabolism and Nutrition Disorders:

    Hyperkalemia, hyponatremia, and hypervolemia.

    Nervous System Disorders:

    Hyponatremic encephalopathy.

  • 7 DRUG INTERACTIONS

    7.1 Drugs that Affect Electrolyte and/or Fluid Balance

    Hyperkalemia

    Administration of Lactated Ringer’s Injection to patients concomitantly treated or recently treated with drugs that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other hyperkalemia risk factors. Avoid use of Lactated Ringer’s Injection in patients receiving drugs that are associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or calcineurin inhibitors). If concomitant use cannot be avoided, closely monitor serum potassium concentrations during concomitant use [see Warnings and Precautions (5.4)].

    Hyponatremia

    Administration of Lactated Ringer’s Injection to patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. These drugs include diuretics and those that cause SIADH (e.g. arginine vasopressin analogs, certain antiepileptic, psychotropic, or cytotoxic drugs). Avoid use of Lactated Ringer’s Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5)].

    Hypercalcemia

    Avoid the use of Lactated Ringer’s Injection in patients treated with thiazide diuretics or vitamin D because these drugs can increase the risk of hypercalcemia. If use cannot be avoided, closely monitor serum calcium concentrations during concomitant use [see Warnings and Precautions (5.6)].

    Hypernatremia and Fluid Retention

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

    7.2 Lithium

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

    7.3 Digoxin

    Administration of calcium via use of Lactated Ringer’s Injection may increase digoxin’s effects and lead to digoxin toxicity including serious or fatal cardiac arrhythmias. In digoxin-treated patients, consider reducing the volume and/or rate of Lactated Ringer’s Injection administration.

    7.4 Drugs with pH-Dependent Renal Elimination

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

    7.5 Interference of Lactated Ringer’s Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis

    Because administration of Lactated Ringer’s Injection may interfere with the interpretation of serum lactate levels in patients with severe metabolic acidosis, assessment of the patient’s clinical status should not solely rely on the measurement of serum lactate.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    Lactated Ringer’s as a source of water and electrolytes has been used for decades during labor and delivery. Although there are no reports of use of Lactated Ringer’s in other stages of pregnancy, exposure during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with this drug.

    The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    8.2 Lactation

    Risk Summary

    Lactated Ringer’s as a source of water and electrolytes has been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the presence of Lactated Ringer’s Injection in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lactated Ringer’s Injection and any potential adverse effects on the breastfed infant from Lactated Ringer’s Injection or from the underlying maternal condition.

    8.4 Pediatric Use

    Lactated Ringer’s Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1)].

    The safety and effectiveness of Lactated Ringer’s Injection for use as a source of water and electrolytes or as an alkalinizing agent have been established in pediatric patients of all ages, including neonates.

    Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions (5.4, 5.5, 5.8, 5.9)]. Administration of a lactate-containing intravenous solution, including Lactated Ringer’s Injection to pediatric patients should account for liver and kidney maturation (the kidney function affects the biotransformation and renal excretion of lactate) [see Warnings and Precautions (5.9)].

    8.5 Geriatric Use

    Geriatric patients treated with Lactated Ringer’s Injection are at increased risk of developing electrolyte imbalances. Lactated Ringer’s Injection is substantially excreted by the kidney, and the risk of adverse reactions to Lactated Ringer’s Injection may be greater in patients with renal impairment than in patients with normal renal function. Because geriatric patients are more likely to have decreased renal function, consider monitoring renal function in geriatric patients and consider starting the infusion at the low end of the dosing range.

    8.6 Renal Impairment

    Administration of Lactated Ringer’s Injection to patients with or at risk of severe renal impairment, may result in hyperkalemia and/or fluid overload [see Warnings and Precautions (5.4, 5.7, 5.9)]. Avoid Lactated Ringer’s Injection in patients with severe renal impairment. If use cannot be avoided in such patients, monitor for development of these adverse reactions.

    8.7 Hepatic Impairment

    In patients with severe hepatic impairment, lactate metabolism may be impaired and Lactated Ringer’s Injection may not produce alkalinization. Closely monitor serum lactate levels and acid-base status in such patients.

  • 10 OVERDOSAGE

    Excessive administration of Lactated Ringer’s Injection can cause:

    • Hyperkalemia and hypernatremia, especially in patients with severe renal impairment.
    • Fluid overload (which can lead to pulmonary and/or peripheral edema).
    • Metabolic alkalosis with or without hypokalemia.
    • Loss of bicarbonate with an acidifying effect
    • Hypercalcemia

    Overdose interventions include Lactated Ringer’s Injection discontinuation, treatment of hyperkalemia, and close monitoring of fluid balance, electrolyte concentrations, and acid-base balance [see Warnings and Precautions (5.4, 5.5, 5.6, 5.7, 5.8)].

  • 11 DESCRIPTION

    Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration.

    Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

    Table 1

  • * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L.
  • † pH may be adjusted with Hydrochloric Acid NF or Sodium Hydroxide NF.
    		•
      

    Size (mL)    		 Composition (g/L) 
    Osmolarity*  (mOsmol/L) (calc)    		 
    pH†     		Ionic Concentration
    (mEq/L)    		 
    Caloric Content (kcal/L)
    Sodium Chloride, USPSodium LactatePotassium Chloride, USPCalcium Chloride, USPSodiumPotassiumCalciumChlorideLactate
    Lactated
    Ringer’s
    Injection, USP    		 500
    1000    		63.10.30.22746.2
    (6.0 to
    7.5)    		13043109289

     

    The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2.

    Table 2

     Ingredients Molecular Formula Molecular Weight
     Sodium Chloride USP Na+Cl– 58.44
     Sodium Lactate Sodium Lactate 112.06
     Potassium Chloride USP K+Cl– 74.55
     Calcium Chloride Dihydrate USP Calcium Chloride Dihydrate USP 147.02

    Not made with natural rubber latex, PVC or DEHP.

    The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. 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.

    The closure system has two ports; the one for the administration set has a tamper evident foil cover and the other is a medication addition site [see Dosage and Administration (2.3)].

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

     Lactated Ringer’s Injection is a source of water, electrolytes, and produces an alkalinizing effect.

    • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.
    • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.
    • Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.
    • Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.
    • Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency).

    12.2 Pharmacodynamics

    The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of Lactated Ringer’s Injection have not been fully characterized.

    12.3 Pharmacokinetics

    Elimination

    Metabolism/Excretion

    Potassium: Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder is excreted in feces and to a smaller extent, in perspiration.

    Sodium and Chloride: 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.

    Lactate: In the liver, lactate is metabolized to carbon dioxide and water by oxidative metabolism and consumption of hydrogen cations.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenicity, genetic toxicology, and animal fertility studies have not been conducted with Lactated Ringer’s Injection.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    How Supplied

    Lactated Ringer’s Injection, USP is a clear, colorless solution packaged in single-dose containers.

    Lactated Ringer’s Injection, USP is supplied sterile and nonpyrogenic in EXCEL® Plus Containers. The 1000 mL containers are packaged 12 per case, and 500 mL containers are packaged 24 per case.

    It is available in the following presentations:

     NDC REF Size
     0264-7500-00 Q7500 1000 mL
     0264-7501-10 Q7501 500 mL

    Storage and Handling

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Minimize Exposure of Lactated Ringer’s Injection, USP to heat.

    Avoid excessive heat. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    EXCEL is a registered trademark of B. Braun Medical Inc.

    Rx only

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y36-003-093   LD-741-3

  • PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

    Lactated Ringer's
    Injection USP

    REF Q7500
    NDC: 0264-7500-00

    1000 mL
    EXCEL® PLUS CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.6 g;
    Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g;
    Calcium Chloride2H2O USP 0.02 g; Water for Injection USP qs

    pH may be adjusted with HCl NF or NaOH NF
    pH: 6.2 (6.0-7.5); Calc. Osmolarity: 274 mOsmol/liter

    Electrolytes (mEq/liter):    Na+130;    K+4;    Ca++3;
    Cl– 109; Lactate 28

    Sterile, nonpyrogenic. Single-dose container. Do not administer
    simultaneously with blood. Do not use in series connection. For intravenous
    use only. Use only if solution is clear and container and seals are intact.

    WARNINGS: NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

    Some additives may be incompatible. Consult with pharmacist. When
    introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.
    Dosage: See Prescribing Information.

    Do not remove overwrap until ready for use. After removing the overwrap,
    check for minute leaks by squeezing container firmly. If leaks are found,
    discard solution as sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    Logo

    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y94-003-498
    LD-739-2

    1000 mL

  • PRINCIPAL DISPLAY PANEL - 500 mL Container Label

    Lactated Ringer's
    Injection USP

    REF Q7501
    NDC: 0264-7501-10

    500 mL
    EXCEL® PLUS CONTAINER

    Each 100 mL contains: Sodium Chloride USP 0.6 g; Sodium Lactate 0.31 g;
    Potassium Chloride USP 0.03 g; Calcium Chloride2H2O USP 0.02 g;
    Water for Injection USP qs

    pH may be adjusted with HCl NF or NaOH NF
    pH: 6.2 (6.0-7.5); Calc. Osmolarity: 274 mOsmol/liter

    Electrolytes (mEq/liter): Na+130; K+4; Ca++3; Cl– 109; Lactate 28

    Sterile, nonpyrogenic. Single-dose container. Do not administer simultaneously with blood.
    Do not use in series connection. For intravenous use only. Use only if solution is clear
    and container and seals are intact.

    WARNINGS: NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

    Some additives may be incompatible. Consult with pharmacist. When introducing additives, use
    aseptic techniques. Mix thoroughly. Do not store.

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information.

    Do not remove overwrap until ready for use. After removing the overwrap, check for
    minute leaks by squeezing container firmly. If leaks are found, discard solution as
    sterility may be impaired.

    Not made with natural rubber latex, PVC or DEHP.

    Rx only

    Logo

    EXCEL is a registered trademark of B. Braun Medical Inc.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Y94-003-497
    LD-740-2

    500 mL
  • INGREDIENTS AND APPEARANCE
    LACTATED RINGERS 
    sodium chloride, sodium lactate, potassium chloride, and calcium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0264-7500
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.6 g  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE0.31 g  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE0.03 g  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0264-7500-0012 in 1 CASE03/01/2023
    11000 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC: 0264-7500-1024 in 1 CASE03/01/2023
    2500 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01963203/01/2023
    Labeler - B. Braun Medical Inc. (002397347)
    • © 2026 FDA.report
    This site is not affiliated with or endorsed by the FDA.