TPN Electrolytes

TPN ELECTROLYTES- sodium chloride, calcium chloride, potassium chloride, magnesium chloride and sodium acetate anhydrous injection, solution, concentrate
Hospira, Inc.

Multiple Electrolyte Additive

Contains No Phosphate

Rx only

Concentrated Solution — For intravenous use only after dilution and thorough mixing.

Formulated to provide additive electrolytes for patients receiving total parenteral nutrition.

Plastic Vial

DESCRIPTION

TPN Electrolytes (multiple electrolyte additive) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular ions for intravenous infusion after dilution as a maintenance electrolyte replenisher only. It contains no phosphate and no bacteriostat, antimicrobial agent or added buffer. The pH is 6.6 (6.0 to 7.5). May contain hydrochloric acid for pH adjustment. The osmolar concentration is 6.2 mOsmol/mL (calc.).

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*Total Parenteral Nutrition

Ingredients and ion constituents of the solution are as follows:

Ingredient or Ion

mg/20 mL

mEq/20 mL

Sodium Chloride

321

Calcium Chloride (dihydrate)

331

Potassium Chloride

1491

Magnesium Chloride (hexahydrate)

508

Sodium Acetate (anhydrous)

2420

Sodium (Na+)

35

Potassium (K+)

20

Calcium (Ca++)

4.5

Magnesium (Mg++)

5

Chloride (Cl)

35

Acetate (CH3 COO)

29.5

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

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

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

Magnesium Chloride, USP hexahydrate is chemically designated MgCl2 • 6H2 O, deliquescent crystals very soluble in water.

Sodium Acetate, USP anhydrous is chemically designated C2 H3 NaO2 , a hygroscopic powder very soluble in water.

Water for Injection, USP is chemically designated H2 O.

The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

CLINICAL PHARMACOLOGY

TPN Electrolytes (multiple electrolyte additive) helps to maintain normal cellular metabolism during TPN (total parenteral nutrition). Providing electrolytes in appropriate amounts prevents deficiency symptoms which otherwise would occur in their absence.

Cations: Sodium is the principal extracellular cation; it helps maintain motor nerve depolarization, proper fluid balance and normal renal metabolism. Potassium is the principal intracellular cation; it helps transport dextrose across the cell membrane and contributes to normal renal function. Magnesium is an important cofactor for enzymatic reactions and helps to maintain normal CNS (central nervous system) activity and amino acid utilization. Calcium participates in muscle contraction, blood coagulation and helps maintain normal neuromuscular function.

Anions: Chloride is the principal extracellular anion which, along with bicarbonate, is involved in maintaining proper anion balance. Acetate is an important metabolic intermediate in the tricarboxylic acid cycle and is a bicarbonate alternate.

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.

Approximately 80% of body calcium (Ca++) is excreted in the feces as insoluble salts; urinary excretion accounts for the remaining 20%.

Potassium (K+) is found in low concentration in the plasma and extracellular fluids (3.5 to 5.0 mEq/liter in a healthy adult). 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.

Magnesium (Mg++) is the second most plentiful intracellular cation. Normal plasma concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium is excreted solely by the kidney at a rate proportional to the plasma concentration and glomerular filtration.

Acetate (CH3 COO) provides bicarbonate (HCO3 ) by metabolic conversion in the liver. This has been shown to proceed readily even in the presence of severe liver disease.

INDICATIONS AND USAGE

TPN Electrolytes (multiple electrolyte additive) is indicated for use as a supplement to nutritional solutions containing concentrated dextrose and amino acids delivered by central venous infusion, to help maintain electrolyte homeostasis in adult patients.

CONTRAINDICATIONS

TPN Electrolytes (multiple electrolyte additive) is contraindicated in pathological conditions where additives of potassium, sodium, calcium, magnesium or chloride could be clinically deleterious, e.g., anuria, hyperkalemia, heart block or myocardial damage and severe edema due to cardiovascular, renal or hepatic failure.

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