Potassium Chloride in Lactated Ringers and Dextrose

POTASSIUM CHLORIDE IN LACTATED RINGERS AND DEXTROSE — potassium chloride , sodium chloride , calcium chloride , sodium lactate and dextrose monohydrate injection, solution
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DESCRIPTION

Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only.

See Table 1 below for summary of content and characteristics of this solution.

Table 1 COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L)
Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP
mEq Potassium Added Size (mL) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate
20 mEq 1000 50 1.79 6 3.1 0.2 563
pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L
Calcium (Ca++) Sodium (Na+) Potassium (K+) Chloride (Cl-) Lactate
4.9(3.5 to 6.5) 2.7 130 24 129 28 179

May contain HCl for pH adjustment.

The solution contains no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.

This solution is a parenteral fluid, nutrient and/or electrolyte replenisher.

Dextrose, USP is chemically designated D-glucose, monohydrate (C6 H12 O6 • H2 O), a hexose sugar freely soluble in water. It has the following structural formula:

Dextrose Structural Formula

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.

Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl2 • 2H2 O), white fragments or granules freely soluble in water.

Sodium Lactate, USP is chemically designated monosodium lactate [CH3 CH(OH)COONa], a 50% aqueous solution miscible in water. It has the following structural formula:

Calcium Chloride Structural Formula

Water for Injection, USP is chemically designated H2 0.

The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

CLINICAL PHARMACOLOGY

When administered intravenously, this solution provides a source of water and electrolytes with 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%.

Sodium lactate provides sodium (Na+) and lactate (C3 H5 O) 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 mEqK/liter.

Intravenous solutions containing potassium chloride are particularly intended to provide needed potassium cation (K+). Potassium is the chief cation of body cells (160 mEq/liter of intracellular water). It is found in low concentration in plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). 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. A deficiency of either potassium or chloride will lead to a deficit of the other.

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.

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.

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