LACTATED RINGERS AND DEXTROSE

LACTATED RINGERS AND DEXTROSE- dextrose monohydrate, sodium lactate, sodium chloride, potassium chloride and calcium chloride injection, solution
HF Acquisition Co LLC, DBA HealthFirst

SPL UNCLASSIFIED

Flexible Plastic Container

Rx only

DESCRIPTION

These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories.

Each 100 mL of Lactated Ringer’s Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5).

Each 100 mL of Lactated Ringer’s and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer’s Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5).

The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.

The solutions are parenteral fluid, nutrient and/or electrolyte replenishers.

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:

Description 1
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Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 • 2 H2O), white fragments or granules freely soluble in water.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Sodium Lactate, USP is chemically designated monosodium lactate [CH3CH(OH)COONa], a 60% aqueous solution miscible in water.

It has the following structural formula:

Description 2
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Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of their chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

CLINICAL PHARMACOLOGY

When administered intravenously, these solutions provide sources of water and electrolytes with or without minimal carbohydrate calories. Their electrolyte content resembles that of the principal ionic constituents of normal plasma and the solutions therefore are suitable for parenteral replacement of extracellular losses of fluid and electrolytes, with or without carbohydrate calories.

Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories.

Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

Calcium chloride in water dissociates to provide calcium (Ca++) and chloride (Cl−) ions. They are normal constituents of the body fluids and are dependent on various physiologic mechanisms for maintenance of balance between intake and output. Approximately 80% of body calcium is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.

Potassium chloride in water dissociates to provide potassium (K+) and chloride (Cl−) ions. Potassium is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). It is the chief cation of body cells (160 mEq/liter of intracellular water). Potassium plays an important role in electrolyte balance. Normally about 80 to 90% of the potassium intake is excreted in the urine; the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion.

Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl−) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.

Sodium lactate provides sodium (Na+) and lactate (C3H503−) ions. The lactate anion is in equilibrium with pyruvate and has an alkalizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. In the liver, lactate is metabolized to glycogen which is ultimately converted to carbon dioxide and water by oxidative metabolism. The sodium (Na+) ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). The normal plasma level of lactate ranges from 0.9 to 1.9 mEq/liter.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

INDICATIONS & USAGE

These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient.

CONTRAINDICATIONS

Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS.

WARNINGS

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

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

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 exists edema with sodium retention.

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

Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions.

The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

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