Baxter 2B1462X - Cardioplegic Solution, for Cardiac Perfusion, 1000 ml, Viaflex Plastic Container, Liquid Premix, 14/cs (Rx) (Continental US Only, Excluding IN and ND)

Baxter 2B1462X - Cardioplegic Solution, for Cardiac Perfusion, 1000 ml, Viaflex Plastic Container, Liquid Premix, 14/cs (Rx) (Continental US Only, Excluding IN and ND)

Baxter 2B1462X 5% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container

Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a core solution intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery.

Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Calcium (Ca++) 2.4 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Sodium (Na+) 110 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition.

It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pHs of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Ca++ 2.4 mEq, Mg++ 32 mEq, K+ 16 mEq, Na+ 120 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. 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 degree celsius/77 degree fahrenheit during transport and storage will lead to minor losses in 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.

Baxter 2B1462X Indications and Usage

Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.

Clinical Pharmacology

Cardioplegic Solution with added sodium bicarbonate when cooled and instilled into the coronary artery vasculature, causes prompt arrest of cardiac electromechanical activity, combats intracellular ion losses and buffers ischemic acidosis. When used with hypothermia and ischemia, the action may be characterized as cold ischemic potassium-induced cardioplegia.

This is conducive to providing the surgeon with a quiet, relaxed heart and bloodless field of operation.

Calcium (Ca⁺⁺) ion in low concentration is included in the solution to maintain integrity of cell membrane to ensure that there is no likelihood of calcium paradox during reperfusion.

Magnesium (Mg⁺⁺) ion may help stabilize the myocardial membrane by inhibiting a myosin phosphorylase, which protects adenosine triphosphate (ATP) reserves for postischemic activity. The protective effects of magnesium and potassium have been shown to be additive.

Potassium (K⁺) ion concentration is responsible for prompt cessation of mechanical myocardial contractile activity. The immediacy of the arrest thus preserves energy supplies for postischemic contractile activity in diastole.

The chloride (Cl^-) and sodium (Na⁺) ions have no specific role in the production of cardiac arrest. Sodium is essential to maintain ionic integrity of myocardial tissue. The chloride ions are present to maintain the electroneutrality of the solution.

Added bicarbonate (HCO3^-) anion is included as a buffer to render the solution slightly alkaline and compensate for the metabolic acidosis that accompanies ischemia.