FDA

Lactated Ringer'S and Dextrose 5% in Plastic Container

Approved 22 Mar 1971InjectionInjectable

Indications

Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. ( 1 )

Contraindications

Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in:

Neonates (28 days of age or younger) who are 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 [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] .
Patients with known hypersensitivity to any of the components of Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] .
Patients with clinically significant hyperglycemia [see Warnings and Precautions (5.7) ] .
Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 )
Patients with known hypersensitivity to any of the components of Lactated Ringer’s and Dextrose (5%) Injection. ( 4 )
Patients with clinically significant hyperglycemia. ( 4 )

Warnings and precautions

Serious Risks with Inappropriate Use with Ceftriaxone : Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone. In patients older than 28 days, ceftriaxone and Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions. ( 4 , 5.1 , 8.4 )
Air Embolism : Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. Pressure infusion is not recommended to increase flow rates, but if necessary, remove all air from the bag prior to initiating infusion. ( 5.2 )

Indications

Contraindications

Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in:

Neonates (28 days of age or younger) who are 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 [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] .
Patients with known hypersensitivity to any of the components of Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] .
Patients with clinically significant hyperglycemia [see Warnings and Precautions (5.7) ] .
Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 )
Patients with known hypersensitivity to any of the components of Lactated Ringer’s and Dextrose (5%) Injection. ( 4 )
Patients with clinically significant hyperglycemia. ( 4 )

Warnings and precautions

Serious Risks with Inappropriate Use with Ceftriaxone : Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone. In patients older than 28 days, ceftriaxone and Lactated Ringer’s and Dextrose (5%) Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions. ( 4 , 5.1 , 8.4 )
Air Embolism : Use a non-vented infusion set or close the vent on a vented set and use a dedicated line without any connections. Pressure infusion is not recommended to increase flow rates, but if necessary, remove all air from the bag prior to initiating infusion. ( 5.2 )

Interactions

Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 )
Lithium : Avoid concomitant use. If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. ( 7.2 )
Digoxin : Consider reducing the volume or rate of Lactated Ringer’s and Dextrose (5%) Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 )
Drugs with pH-Dependent Renal Elimination : Renal clearance of acidic drugs may be increased. In contrast, renal clearance of alkaline drugs may be decreased. ( 7.4 )

7.1 Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Lactated Ringer’s and Dextrose (5%) 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 and Dextrose (5%) 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 and Dextrose (5%) 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 and Dextrose (5%) 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 and Dextrose (5%)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 (5.8) ] .

Hypernatremia and Fluid Retention Administration of Lactated Ringer’s and Dextrose (5%) 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 and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum electrolytes, fluid balance, and acid-base balance during concomitant use.

7.2Lithium

Renal sodium and lithium clearance may be increased during concomitant use of Lactated Ringer’s and Dextrose (5%) Injection and lithium and may result in decreased lithium concentrations. Avoid use of Lactated Ringer’s and Dextrose (5%)Injection in patients receiving lithium. If use cannot be avoided, increase the frequency of monitoring of serum lithium concentrations during concomitant use.

7.3Digoxin Administration

of calcium via use of Lactated Ringer’s and Dextrose (5%) 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 and Dextrose (5%) Injection administration.

7.4Drugs

with pH-Dependent Renal Elimination Due to the alkalinizing action of lactate (formation of bicarbonate), Lactated Ringer’s and Dextrose (5%) 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 and Dextrose (5%) Injection with Interpretation of Serum Lactate Levels in Patients with Severe Metabolic Acidosis Because administration of Lactated Ringer’s and Dextrose (5%) Injection may interfere with the interpretation of serum lactate levels in patients with severe metabolic acidosis, including lactic acidosis, assessment of the patient’s clinical status should not solely rely on the measurement of serum lactate.

Adverse reactions

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

Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ]
Air Embolism [see Warnings and Precautions (5.2) ]
Hypersensitivity Reactions [see Warnings and Precautions (5.3) ]
Potassium Imbalances [see Warnings and Precautions (5.4) ]
Hyponatremia [see Warnings and Precautions (5.5) ]
Neonatal Hypoglycemia [see Warnings and Precautions (5.6) ]
Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.7) ]
Hypercalcemia [see Warnings and Precautions (5.8) ]
Fluid Overload [see Warnings and Precautions (5.9) ]
Acid/Base Imbalances [see Warnings and Precautions (5.10) ] The following adverse reactions have been identified during post approval 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, and headache, laryngeal edema, sneezing, and injection site infection. Metabolism and Nutrition Disorders : Hyperkalemia, hyponatremia, and hypervolemia. Nervous System Disorders : Hyponatremic encephalopathy. Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Lactated Ringer'S and Dextrose 5% in Plastic Container

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Lactated Ringer'S and Dextrose 5% in Plastic Container

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Serious Risk with Concomitant Use with Ceftriaxone Precipitation

5.2Air Embolism Cases

5.3Hypersensitivity Reactions

5.4Potassium Imbalances Hyperkalemia

5.5Hyponatremia Lactated Ringer’s and Dextrose (5%)

5.6Neonatal Hypoglycemia

5.7Hyperglycemia and Hyperosmolar Hyperglycemic State Administration

5.8Hypercalcemia Lactated Ringer’s and Dextrose (5%)

5.10Acid/Base Imbalances

Interactions

7.2Lithium

7.3Digoxin Administration

7.4Drugs

Pregnancy and breastfeeding

Adverse reactions

Composition

Official product information

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