Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride
Generic Name: potassium chloride, sodium chloride, calcium chloride, and magnesium chloride
Brand Names:
Plegisol
DESCRIPTION Plegisol (Cardioplegic Solution) is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. 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.
Overview
DESCRIPTION Plegisol (Cardioplegic Solution) is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in water for injection. 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.
Uses
INDICATIONS AND USAGE Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
Dosage
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 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.
Side Effects
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.
Interactions
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 ).
Warnings
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. CONTRAINDICATIONS Plegisol must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP, Hospira List 4900. NOT FOR INTRAVENOUS INJECTION. This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.
Pregnancy
Pregnancy: Animal reproduction studies have not been conducted with Plegisol. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plegisol should be given to a pregnant woman only if clearly needed.
Storage
HOW SUPPLIED Plegisol ® (Cardioplegic Solution) is supplied (without sodium bicarbonate) as follows: Unit of Sale NDC 0409-7969-05 Case of 12 single-dose 1000 mL flexible plastic containers WARNING: Do not use flexible container in series connections. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
Frequently Asked Questions
What is Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride used for?▼
INDICATIONS AND USAGE Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
What are the side effects of Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride?▼
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.
Can I take Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride during pregnancy?▼
Pregnancy: Animal reproduction studies have not been conducted with Plegisol. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Plegisol should be given to a pregnant woman only if clearly needed.
What are the important warnings for Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride?▼
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. CONTRAINDICATIONS Plegisol must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP, Hospira List 4900. NOT FOR INTRAVENOUS INJECTION. This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.