Dextrose in Lactated Ringers

DEXTROSE IN LACTATED RINGERS- dextrose monohydrate, sodium chloride, sodium lactate, potassium chloride and calcium chloride injection, solution
B. Braun Medical Inc.

DESCRIPTION

Each 100 mL of 5% Dextrose in Lactated Ringer’s Injection contains:
Hydrous Dextrose USP 5 g; Sodium Chloride USP 0.6 g
Sodium Lactate 0.31 g; Potassium Chloride USP 0.03 g
Calcium Chloride Dihydrate USP 0.02 g
Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF
pH: 4.6 (4.0–6.0)
Calories per liter: 170
Calculated Osmolarity: 530 mOsmol/liter, hypertonic

Concentration of Electrolytes (mEq/liter): Sodium 130; Potassium 4;Calcium 3; Chloride 112; Lactate (CH₃ CH(OH)COO⁻) 28

5% Dextrose in Lactated Ringer’s Injection is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Sodium Chloride USP	NaCl	58.44
Sodium Lactate	CH3 CH(OH)COONa	112.06
Potassium Chloride USP	KCl	74.55
Calcium Chloride Dihydrate USP	CaCl2 •2H2 O	147.02
Hydrous Dextrose USP		198.17

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. 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.

Addition of medication should be accomplished using complete aseptic technique.

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. Refer to the Directions for Use of the container.

CLINICAL PHARMACOLOGY

5% Dextrose in Lactated Ringer’s Injection provides electrolytes and calories, and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient. This solution also contains lactate which produces a metabolic 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 is a racemic salt containing both the levo form, which is oxidized by the liver to bicarbonate, and the dextro form, which is converted to glycogen. Lactate is slowly metabolized to carbon dioxide and water, accepting one hydrogen ion and resulting in the formation of bicarbonate for the lactate consumed. These reactions depend on oxidative cellular activity.

Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

INDICATIONS AND USAGE

This solution is indicated for use in adults and pediatric patients as a source of electrolytes, calories and water for hydration.

CONTRAINDICATIONS

The use of 5% Dextrose in Lactated Ringer’s Injection is contraindicated in neonates (28 days of age or younger) 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, Drug Interactions, Pediatric Use ].

This solution is contraindicated where the administration of sodium, potassium, calcium, chloride or lactate could be clinically detrimental.

Lactate administration is contraindicated in severe metabolic acidosis or alkalosis, and in severe liver disease or anoxic states which affect lactate metabolism.

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

WARNINGS

Precipitation with Ceftriaxone

Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing solutions, such as 5% Dextrose in Lactated Ringer’s Injection, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with 5% Dextrose in Lactated Ringer’s Injection via a Y-site.

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. 5% Dextrose in Lactated Ringer’s Injection is contraindicated in neonates receiving ceftriaxone.

However, in patients other than neonates, ceftriaxone and 5% Dextrose in Lactated Ringer’s Injection may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid. [see Contraindications, Warnings, Drug Interactions, Pediatric Use ].

Solutions containing lactate are not for use in the treatment of lactic acidosis.

Solutions containing lactate should be used with great care in patients with metabolic or respiratory alkalosis, and in those conditions in which there is an increased level or an impaired utilization of lactate, such as severe hepatic insufficiency.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium ions retention is present.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.

Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.

PRECAUTIONS

General

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Extraordinary electrolytes losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Additional essential electrolytes, minerals and vitamins should be supplied as needed.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients.

Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

The osmolarity of 5% Dextrose in Lactated Ringer’s Injection is 530 mOsmol/liter (calc). Administration of substantially hypertonic solutions may cause venous irritation, including phlebitis.

Solutions containing calcium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease. Parenteral calcium should be administered with extreme caution to patients receiving digitalis preparations.

Solutions containing lactate should be used with caution. Excess administration may result in metabolic alkalosis.

The conversion of lactate to bicarbonate is markedly delayed in the presence of tissue anoxia and reduced capacity of the liver to metabolize lactate. This may occur under conditions such as metabolic acidosis associated with circulatory insufficiency, extracorporeal circulation, hypothermia, glycogen storage disease, liver dysfunction, respiratory alkalosis, shock or cardiac decompensation.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (greater than 300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.