LABOR & DELIVERY SECTION.

Labor and Delivery. Studies have not been conducted to evaluate the effects of Lactated Ringers Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

NURSING MOTHERS SECTION.

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 Ringers Injection, USP is administered to nursing mother.

GERIATRIC USE SECTION.

Geriatric Use. Geriatric patients are at increased risk of developing electrolyte imbalances. Lactated Ringers 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Lactated Ringers Injection, USP in VIAFLEX plastic container is available as follows:CodeSize (mL)NDC 2B2322 250 0338-0117-02 2B2323 500 0338-0117-03 2B2324 1000 0338-0117-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25C); brief exposure up to 40C does not adversely affect the product.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Lactated Ringers Injection, USP is indicated as source of water and electrolytes or as an alkalinizing agent.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Post-Marketing Adverse Reactions. The following adverse reactions associated with the use of Lactated Ringers Injection, USP were identified in clinical trials or postmarketing reports. Because postmarketing reactions were reported voluntarily from population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish 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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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 Ringers Injection, USP. Studies to evaluate the possible impairment of fertility have not been performed.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Lactated Ringers Injection, USP has value as source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.Lactated Ringers Injection, USP produces metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Lactated Ringers Injection, USP is contraindicated in:oNewborns (<=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 neonates bloodstream.oPatients older than 28 days, including adults, administered ceftriaxone simultaneously through the same infusion line (e.g., via Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with compatible fluid.oPatients with known hypersensitivity to sodium lactate (see WARNINGS).. oNewborns (<=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 neonates bloodstream.. oPatients older than 28 days, including adults, administered ceftriaxone simultaneously through the same infusion line (e.g., via Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with compatible fluid.. oPatients with known hypersensitivity to sodium lactate (see WARNINGS).

DESCRIPTION SECTION.

DESCRIPTION. Lactated Ringers Injection, USP is 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 1Composition (g/L)Ionic Concentration (mEq/L)Size (mL)Sodium Chloride, USP, (NaCl)Sodium Lactate,(C3H5NaO3)Potassium Chloride, USP, (KCl)Calcium Chloride, USP(CaCl2.2H2O)Osmolarity (mOsmol/L) (calc)pHSodiumPotassiumCalciumChlorideLactateCaloric Content (kcal/L)Lactated Ringers Injection, USP 250 500100063.10.30.22736.5 (6.0 to 7.5) 13042.7109289The VIAFLEX plastic container is fabricated from 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 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Important Administration Instructions oLactated Ringers Injection, USP is intended for intravenous administration using sterile equipment. oDo not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. oSet the vent to the closed position on vented intravenous administration set to prevent air embolism. oUse dedicated line without any connections to avoid air embolism. oDo 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. oPrior 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. oDo not administer Lactated Ringers 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 Ringers Injection, USP.Dosing InformationThe 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 physician experienced in intravenous fluid therapy.Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. Ceftriaxone is known to be incompatible with Lactated Ringers Injection, USP due to precipitate formation. Ceftriaxone must not be mixed with Lactated Ringers Injection, USP. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Use content immediately after opening the container. Discard any unused portion.. oLactated Ringers Injection, USP is intended for intravenous administration using sterile equipment. oDo not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. oSet the vent to the closed position on vented intravenous administration set to prevent air embolism. oUse dedicated line without any connections to avoid air embolism. oDo 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. oPrior 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. oDo not administer Lactated Ringers 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 Ringers Injection, USP.

DRUG INTERACTIONS SECTION.

Drug Interactions. CeftriaxoneFor information on interaction with ceftriaxone see CONTRAINDICATIONS.Other Drugs that Increase the Risk of HyponatremiaAdministration of Lactated Ringers Injection, USP to patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.Avoid use of Lactated Ringers 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 BalanceAdministration of Lactated Ringers 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 Ringers 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 HyperkalemiaAdministration of Lactated Ringers 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 Ringers 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.LithiumRenal sodium and lithium clearance may be increased during administration of Lactated Ringers Injection, USP and result in decreased lithium concentrations. Avoid use of Lactated Ringers Injection, USP in patients receiving lithium. If use cannot be avoided, monitor serum lithium concentrations during concomitant use. DigoxinAdministration 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 Ringers Injection, USP.Other Drugs that Increase the Risk of HypercalcemiaAvoid Lactated Ringers Injection, USP in patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.Drugs with pH Dependent Renal EliminationDue to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringers 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.

OVERDOSAGE SECTION.

OVERDOSAGE. Excessive administration of Lactated Ringers Injection, USP can cause:ohyperkalemia and hypernatremia, especially in patients with severe renal impairment.ofluid overload (which can lead to pulmonary and/or peripheral edema). ometabolic alkalosis with or without hypokalemia.oloss of bicarbonate with an acidifying effect.ohypercalcemia.See WARNINGSand 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 Ringers 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).. ohyperkalemia and hypernatremia, especially in patients with severe renal impairment.. ofluid overload (which can lead to pulmonary and/or peripheral edema). ometabolic alkalosis with or without hypokalemia.. oloss of bicarbonate with an acidifying effect.. ohypercalcemia.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABELING PRINCIPAL DISPLAY PANEL. Container Label Container Label LOTEXP2B2322NDC 0338-0117-02Lactated RingersInjection USP250 mL Each100 mL contains600 mg SodiumChloride USP 310 mg Sodium Lactate30 mg Potassium Chloride USP 20 mgCalcium Chloride USP pH 6.5 (6.0 to7.5) mEq/L Sodium 130 Potassium 4Calcium 2.7 Chloride 109 Lactate 28Osmolarity 273 mOsmol/L (calc)Sterile Nonpyrogenic Single dosecontainer Not for use in the treatment of lactic acidosis Additives may beincompatible Consult with pharmacistif available When introducing additivesuse aseptic technique Mix thoroughlyDo not store Dosage Intravenously asdirected by physician See directionsCautions Squeeze and inspect innerbag which maintains product sterilityDiscard if leaks are found Must not beused in series connections Do notadminister simultaneously with bloodDo not use unless solution is clear RxOnly Store unit in moisture barrieroverwrap at room temperature(25C/77F) until ready to use Avoidexcessive heat See insertViaflex containerPL 146 plasticBAXTER Viaflex and PL 146 are trademarks of Baxter International IncBaxterBaxter Healthcare CorporationDeerfieldIL60015 USAMade in USAFor product information1-800-933-0303LOTEXP2B2324NDC 0338-0117-04Lactated RingersInjection USP1000 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 4Calcium 2.7 Chloride 109 Lactate 28 Osmolarity 273 mOsmol/L (calc) Sterile Nonpyrogenic Single dose container Not 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 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 (25C/77F) until ready to use Avoid excessive heat See insertViaflex containerPL 146 plasticBAXTER VIAFLEX and PL 146 are trademarks of Baxter International IncFor Product Information 1-800-933-0303BaxterBaxter Healthcare CorporationDeerfieldIL60015 USAMade in MexicoCarton Label Carton Label FOR HI-RES INK JET: 2B2322Q 36-250 ML VIAFLEX(R) CONTAINER LACTATED RINGERS INJECTION, USP EXP XXXXX SECONDARY BAR CODE (17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01)50303380117029 2B2B2322Q 2B2322QQ Lactated Ringers Representative container label. Representative Container Label for Mexico NDC 0338-0117-04. Lactated Ringers Representative carton label.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness of Lactated Ringers 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 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 complication of hyponatremia (see WARNINGS ).

PRECAUTIONS SECTION.

PRECAUTIONS. Patients with Renal Impairment Administration of Lactated Ringers Injection, USP in patients with or at risk of severe renal impairment, may result in hyperkalemia and/or fluid overload (see WARNINGS). Avoid Lactated Ringers 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 Ringers Injection, USP may not produce alkalization. Consider when monitoring serum lactate levels.. Hypercalcemia Lactated Ringers Injection, USP contains calcium salts and may cause hypercalcemia. Avoid administration of Lactated Ringers 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 Ringers 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 Ringers 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 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 complication of hyponatremia (see WARNINGS ).. Geriatric Use. Geriatric patients are at increased risk of developing electrolyte imbalances. Lactated Ringers 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. CeftriaxoneFor information on interaction with ceftriaxone see CONTRAINDICATIONS.Other Drugs that Increase the Risk of HyponatremiaAdministration of Lactated Ringers Injection, USP to patients treated concomitantly with medications associated with hyponatremia may increase the risk of developing hyponatremia.Avoid use of Lactated Ringers 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 BalanceAdministration of Lactated Ringers 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 Ringers 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 HyperkalemiaAdministration of Lactated Ringers 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 Ringers 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.LithiumRenal sodium and lithium clearance may be increased during administration of Lactated Ringers Injection, USP and result in decreased lithium concentrations. Avoid use of Lactated Ringers Injection, USP in patients receiving lithium. If use cannot be avoided, monitor serum lithium concentrations during concomitant use. DigoxinAdministration 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 Ringers Injection, USP.Other Drugs that Increase the Risk of HypercalcemiaAvoid Lactated Ringers Injection, USP in patients treated with thiazide diuretics or vitamin D, as these can increase the risk of hypercalcemia.Drugs with pH Dependent Renal EliminationDue to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringers 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 Ringers Injection, USP. It is also not known whether Lactated Ringers Injection, USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Lactated Ringers Injection, USP should be given to 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 Ringers 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 Ringers 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 Ringers Injection, USP is administered to nursing mother.

SPL UNCLASSIFIED SECTION.

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

TERATOGENIC EFFECTS SECTION.

Teratogenic Effects. Animal reproduction studies have not been conducted with Lactated Ringers Injection, USP. It is also not known whether Lactated Ringers Injection, USP can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Lactated Ringers Injection, USP should be given to pregnant woman only if clearly needed.For Hypersensitivity Reactions During Pregnancy see WARNINGS.

WARNINGS SECTION.

WARNINGS. Potassium Content The potassium concentration in Lactated Ringers Injection, USP is similar to the concentration in plasma; however, it is insufficient to produce useful effect in case of severe potassium deficiency. Lactated Ringers Injection, USP is not recommended for the treatment of severe hypokalemia.. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported with Lactated Ringers Injection, USP (see ADVERSE REACTIONS). Stop the infusion immediately if signs or symptoms of hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.. Electrolyte Imbalances HyponatremiaLactated Ringers 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 Ringers 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 Ringers 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 OverloadDepending on the volume and the rate of infusion, the intravenous administration of Lactated Ringers Injection, USP can cause electrolyte disturbances such as overhydration and congested states, including pulmonary congestion and edema. Avoid Lactated Ringers 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.HyperkalemiaPotassium-containing solutions, including Lactated Ringers Injection, USP, may increase the risk of hyperkalemia. Patients at increased risk of developing hyperkalemia include those:oWith 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.oTreated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS, Drug Interactions). Avoid use of Lactated Ringers Injection, USP in patients with, or at risk for, hyperkalemia. If use cannot be avoided, monitor serum potassium concentrations.AlkalosisBecause lactate is metabolized to bicarbonate, administration of Lactated Ringers Injection, USP may result in, or worsen, metabolic alkalosis. Avoid intravenous administration of Lactated Ringers Injection, USP in patients with alkalosis or at risk for alkalosis.. oWith 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.. oTreated concurrently or recently with agents or products that cause or increase the risk of hyperkalemia (see PRECAUTIONS, Drug Interactions).