Cardioplegic

What is Cardioplegic?

DESCRIPTION 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. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE ). 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 adde

Uses of Cardioplegic

Established uses

• 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.

How to take Cardioplegic

DOSAGE AND ADMINISTRATION The following information is suggested as a guide and is subject to variation according to the preference and experience of the surgeon. 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 Hospira 1 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 pH’s 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 used within 24 hours. The solution should be cooled to 4°C prior to use. Following institution of cardiopulmonary bypass at perfusate temperatures of 28° to 30°C, and after cross-clamping of the ascending aorta, the buffered solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m 2 /minute (about 540 mL/min in a 5’ 8”, 70 kg adult

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

DOSAGE AND ADMINISTRATION The following information is suggested as a guide and is subject to variation according to the preference and experience of the surgeon. 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 Hospira 1 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 pH’s 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 used within 24 hours. The solution should be cooled to 4°C prior to use. Following institution of cardiopulmonary bypass at perfusate temperatures of 28° to 30°C, and after cross-clamping of the ascending aorta, the buffered solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m 2 /minute (about 540 mL/min in a 5’ 8”, 70 kg adult

Side effects of Cardioplegic

Common

• ADVERSE REACTIONS Intraoperative and perioperative potential hazards of open heart surgery include myocardial infarction, electrocardiographic abnormalities, and arrhythmias, including ventricular fibrillation.
• Spontaneous recovery after cardioplegic cardiac arrest may be delayed or absent when circulation is restored.
• Defibrillation by electric shock may be required to restore normal cardiac function.

Warnings and who should not take it

Who should NOT take Cardioplegic?

• CONTRAINDICATIONS Baxter Cardioplegic Solution must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP, Hospira 1 List 4900.
• NOT FOR INTRAVENOUS INJECTION.
• This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.

Warnings and precautions

• WARNINGS This solution should be used only by those trained to perform open heart surgery.
• This solution is intended only for use during cardiopulmonary bypass when the coronary circulation is isolated from the systemic circulation (See INDICATIONS AND USAGE ).
• Do not instill the solution into the coronary vasculature unless sodium bicarbonate has been added.
• If large volumes of cardioplegic solution are infused and allowed to return to the heart lung machine without any venting from the right heart, then plasma magnesium and potassium levels may rise.
• Development of severe hypotension and metabolic acidosis while on bypass has been reported when large volumes (8 to 10 liters) of solution are instilled and allowed to enter the pump and then the systemic circulation.
• Right heart venting is therefore recommended.

Overdose

OVERDOSAGE Overzealous instillation of the solution may result in unnecessary dilatation of the myocardial vasculature and leakage into the perivascular myocardium, possibly causing tissue edema (See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS ).

Children and elderly

Interactions

Medicine and medicine

• Drug Interactions Additives may be incompatible.
• Consult with pharmacist, if available.
• When introducing additives, use aseptic technique, mix thoroughly and do not store (See INSTRUCTIONS FOR USE ).
• Pregnancy: Animal reproduction studies have not been conducted with Cardioplegic Solution.
• It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Cardioplegic Solution should be given to a pregnant woman only if clearly needed.

Frequently asked questions