Lactated Ringers

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.

Injection: Lactated Ringer’s Injection, USP as a clear, sterile, and nonpyrogenic solution packaged in single-dose containers: 250 mL, 500 mL, and 1,000 mL.

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

• Serious Risk with Concomitant Use with Ceftriaxone
  [see

  5.1 Serious Risk with Concomitant
  Use with
  Ceftriaxone

  Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as Lactated Ringer’s Injection in the same intravenous administration line. Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used.

  Lactated Ringer’s Injection is contraindicated in neonates who receive ceftriaxone

  [see Contraindications (4), Use in Specific Populations (8.4)].

  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

  .

  ]
• Air Embolism
  [see

  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 (2.3)]

  .

  ]
• Hypersensitivity Reactions
  [see

  5.3 Hypersensitivity Reactions

  Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Lactated Ringer’s Injection

  .

  Stop the Lactated Ringer’s Injection infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop. Initiate appropriate treatment as clinically indicated.

  ]
• Potassium Imbalances
  [see

  5.4 Potassium
  Imbalances

  Hyperkalemia
  
  

  Potassium-containing solutions, including Lactated Ringer’s Injection

  ,

  may increase the risk of hyperkalemia. This risk is increased in patients predisposed to hyperkalemia including those with severe renal impairment, acute dehydration, extensive tissue injury or burns, heart failure, or in those using concomitant drugs that are associated with hyperkalemia.

  Avoid use of Lactated Ringer’s Injection in patients with, or at increased risk for, hyperkalemia. If use cannot be avoided in these patients, closely monitor serum potassium concentrations.

  Hypokalemia
  
  

  The potassium concentration in Lactated Ringer’s Injection is similar to the concentration in plasma. It is insufficient to normalize the serum potassium in patients with severe hypokalemia.

  ]
• Hyponatremia
  [see

  5.5 Hyponatremia

  Lactated Ringer’s Injection may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy and vomiting. The risk of hospital-acquired hyponatremia is increased in younger pediatric patients, geriatric patients, patients treated with diuretics, and patients with cardiac or pulmonary failure or with the syndrome of inappropriate antidiuretic hormone (SIADH) (e.g., postoperative patients, patients concomitantly treated with arginine vasopressin analogs, or certain antiepileptic, psychotropic, or cytotoxic drugs)

  [see Drug Interactions (7.1), Use in Specific Populations (8.4)]

  .

  Avoid Lactated Ringer’s Injection in patients with or at risk for hyponatremia. If use cannot be avoided in these patients, closely monitor serum sodium concentrations.

  Rapid correction of hyponatremia may result in serious neurologic complications such as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and neurologic status.

  ]
• Hypercalcemia
  [see

  5.6 Hypercalcemia

  Lactated Ringer’s Injection contains calcium salts and may cause hypercalcemia. Avoid administration of Lactated Ringer’s Injection in patients with hypercalcemia, those with calcium-containing renal calculi or history of such calculi, those with conditions predisposing to hypercalcemia, or treated with concomitant thiazide diuretics or vitamin D.

  ]
• Fluid Overload
  [see

  5.7 Fluid Overload

  Depending on the administered volume and the infusion rate, administration of Lactated Ringer’s Injection can cause fluid overload, including pulmonary edema.

  Avoid Lactated Ringer’s Injection in patients at risk for fluid and/or solute overload including patients with severe renal impairment. If use cannot be avoided in these patients, monitor fluid balance, electrolyte concentrations and acid base balance, especially during prolonged use.

  ]
• Acid/Base Imbalances
  [see

  5.8 Acid/Base Imbalances

  Because lactate is metabolized to bicarbonate, administration of Lactated Ringer’s Injection may result in, or worsen, metabolic alkalosis. Closely monitor the acid-base balance in patients with, or at risk of, alkalosis.

  In patients with severe hepatic impairment, decreased lactate metabolism may result in worsening anion gap metabolic acidosis. Avoid Lactated Ringer’s Injection in patients with severe hepatic impairment. If use cannot be avoided in these patients, closely monitor serum bicarbonate levels.

  ]

The following adverse reactions have been identified during postapproval 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:

Lactated Ringer’s Injection USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single-dose container intended for intravenous administration.

Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

The chemical name, structural formula, and molecular weight of the active ingredients are shown in Table 2.

Ingredients	Molecular Formula	Molecular Weight
Sodium Chloride USP		58.44
Sodium Lactate		112.06
Potassium Chloride USP		74.55
Calcium Chloride Dihydrate USP		147.02

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film developed for parenteral drugs. It contains no plasticizers and has minimal leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site

Lactated Ringer’s Injection is a source of water, electrolytes, 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.
• Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.
• Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability.
• Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency).