Lactated Ringers

Dosage and Administration (

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.

• •The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. (
  2.1 Dosage Considerations

  The recommended dosage and duration of Lactated Ringer’s Injection is 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.
  )
• •To reduce the risk of air embolism, adhere to the preparation instructions. (
  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 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 it if there is discoloration or formation of precipitates.

  To reduce the risk of air embolism, adhere to the following preparation instructions for Lactated Ringer’s Injection [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

  • 1.000000000000000e+00
    Tear overwrap downside at slit and remove solution container.
  • 2.000000000000000e+00
    Visually inspect the container.
    • o
      If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
    • o
      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.
  • 3.000000000000000e+00
    Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
  • 4.000000000000000e+00
    If supplemental medication is desired, follow directions below

    [see Dosage and Administration (2.3)]

    .

  Preparation for Administration

  • 1.000000000000000e+00
    Suspend container from eyelet support.
  • 2.000000000000000e+00
    Remove protector from outlet port at bottom of container.
  • 3.000000000000000e+00
    Attach administration set according to its accompanying directions.
  ,
  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)]

  .
  )
• •Lactated Ringer’s Injection is for intravenous use. (
  2.3 Important Administration Instructions

  Lactated Ringer’s Injection is for intravenous use.

  Use immediately after removing the overwrap. Discard the unused portion.

  Some additives may be incompatible

  [see Dosage and Administration (2.4)and Contraindications (4)]

  .

  To Add Medication Before Solution Administration

  • 1.000000000000000e+00
    Prepare medication site.
  • 2.000000000000000e+00
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • 3.000000000000000e+00
    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

  • 1.000000000000000e+00
    Close clamp on the set.
  • 2.000000000000000e+00
    Prepare medication site.
  • 3.000000000000000e+00
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • 4.000000000000000e+00
    Remove container from IV pole and/or turn to an upright position.
  • 5.000000000000000e+00
    Evacuate both ports by squeezing them while container is in the upright position.
  • 6.000000000000000e+00
    Mix solution and medication thoroughly.
  • 7.000000000000000e+00
    Return container to in use position and continue administration.
  )
• •Do not administer Lactated Ringer’s Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks. (
  2.4 Drug Incompatibilities

  Do not administer Lactated Ringer’s Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) 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.
  )
• •See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities. (
  2 DOSAGE AND ADMINISTRATION

  • •The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy.
  • •To reduce the risk of air embolism, adhere to the preparation instructions.
  • •Lactated Ringer’s Injection is for intravenous use.
  • •Do not administer Lactated Ringer’s Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks.
  • •See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities.

  2.1 Dosage Considerations

  The recommended dosage and duration of Lactated Ringer’s Injection is 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 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 it if there is discoloration or formation of precipitates.

  To reduce the risk of air embolism, adhere to the following preparation instructions for Lactated Ringer’s Injection [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

  • 1.000000000000000e+00
    Tear overwrap downside at slit and remove solution container.
  • 2.000000000000000e+00
    Visually inspect the container.
    • o
      If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
    • o
      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.
  • 3.000000000000000e+00
    Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
  • 4.000000000000000e+00
    If supplemental medication is desired, follow directions below

    [see Dosage and Administration (2.3)]

    .

  Preparation for Administration

  • 1.000000000000000e+00
    Suspend container from eyelet support.
  • 2.000000000000000e+00
    Remove protector from outlet port at bottom of container.
  • 3.000000000000000e+00
    Attach administration set according to its accompanying directions.

  2.3 Important Administration Instructions

  Lactated Ringer’s Injection is for intravenous use.

  Use immediately after removing the overwrap. Discard the unused portion.

  Some additives may be incompatible

  [see Dosage and Administration (2.4)and Contraindications (4)]

  .

  To Add Medication Before Solution Administration

  • 1.000000000000000e+00
    Prepare medication site.
  • 2.000000000000000e+00
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • 3.000000000000000e+00
    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

  • 1.000000000000000e+00
    Close clamp on the set.
  • 2.000000000000000e+00
    Prepare medication site.
  • 3.000000000000000e+00
    Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
  • 4.000000000000000e+00
    Remove container from IV pole and/or turn to an upright position.
  • 5.000000000000000e+00
    Evacuate both ports by squeezing them while container is in the upright position.
  • 6.000000000000000e+00
    Mix solution and medication thoroughly.
  • 7.000000000000000e+00
    Return container to in use position and continue administration.

  2.4 Drug Incompatibilities

  Do not administer Lactated Ringer’s Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) 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.
  )

Injection: Lactated Ringer’s Injection, USP as a clear, sterile, and nonpyrogenic solution packaged in single-dose VIAFLEX plastic containers: 250 mL, 500 mL, and 1000 mL.

• •Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function. (
  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)]

  .
  )
• •Geriatric patients are more likely to have decreased renal function. Consider monitoring renal function and starting the infusion at the low end of the dosing range. (
  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.
  )
• •Avoid in patients with severe renal impairment. (
  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.
  )
• •Patients with severe hepatic impairment may have impaired lactate metabolism. Closely monitor serum lactate levels and acid-base status. (
  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.
  )