Overview
11 DESCRIPTION Lactated Ringer’s and Dextrose (5%) Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. Dextrose is derived from corn.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, 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.
Indications
- 1 INDICATIONS AND USAGE 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.
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. ( 2.1 ) To reduce the risk of air embolism, adhere to the preparation instructions. ( 2.2 , 5.2 ) Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use ( 2.3 ) Use a peripheral vein to administer if the final dextrose concentration is 5% or less and the osmolarity is less than 900 mOsm/L. ( 2.
Contraindications
- 4 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 components of Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ].
Side Effects
- 6 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.
Interactions
- 7 DRUG 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.