Download Lactated Ringer's Injection, USP and more Summaries Nursing in PDF only on Docsity!
Lactated Ringer’s Injection, USP
in VIAFLEX 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) pH
Ionic Concentration (mEq/L)
Sodium Chloride, USP, (NaCl) Sodium Lactate, (C^ Caloric Content (kcal/L)
H 3
NaO 5
) 3
Potassium Chloride, USP, (KCl)^ Calcium Chloride, USP(CaCl
O) 2
Sodium Potassium Calcium Chloride Lactate Lactated Ringer’s Injection, USP
250 6 3.1 0.3 0.2 273
(6.0 to 7.5)
(^500130) 4 2.7 109 28 9 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
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 Lactated Ringer’s Injection, USP is contraindicated in:
- Newborns (≤28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream.
- Patients older than 28 days, including adults, administered ceftriaxone simultaneously through the same infusion line (e.g., via a Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid.
- Patients with known hypersensitivity to sodium lactate (see WARNINGS ).
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.
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
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 (see WARNINGS ). 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
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 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.
OVERDOSAGE
Excessive administration of Lactated Ringer’s Injection, USP 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.
See WARNINGS and ADVERSE REACTIONS.
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. Interventions include discontinuation of Lactated Ringer’s Injection, USP administration, dose reduction, and other measures as indicated for the specific clinical constellation (e.g., monitoring of fluid balance, electrolyte concentrations and acid base balance).
DOSAGE AND ADMINISTRATION
Important Administration Instructions
- Lactated Ringer’s Injection, USP is intended for intravenous administration using sterile equipment.
- Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.
- Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
- Use a dedicated line without any connections to avoid air embolism.
- Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container.
- Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
- Do not administer Lactated Ringer’s Injection, USP 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, USP.
Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.
Introduction of Additives
- 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 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
Baxter and Viaflex are trademarks of Baxter International
Inc. 07-19-XX-XXXX
Rev. October 2019
