Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride
FDA Drug Information • Also known as: Cardioplegic Solution, Plegisol
- Brand Names
- Cardioplegic Solution, Plegisol
- Route
- INTRA-ARTERIAL
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION 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. Other agents may be added to the solution prior to instillation (See INSTRUCTIONS FOR USE ). Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg, magnesium chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium chloride 643 mg in water for injection. May contain HCl 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 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 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 (HCO 3 ‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these...
What Is Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride Used For?
INDICATIONS AND USAGE Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
Dosage and Administration
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 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 with 1.8 square meters of surface area) given for a period of two to four minutes. Concurrent external cooling (regional hypothermia of the pericardium) may be accomplished by instilling a refrigerated (4°C) physiologic solution such as Normosol ® -R (balanced electrolyte replacement solution) or Ringer's Injection, USP into the chest cavity. Should myocardial electromechanical activity persist or recur, the solution may be reinfused at a rate of 300 mL/m 2 /min for a period of two minutes. Reinfusion of the solution may be repeated every 20 to 30 minutes or sooner if myocardial temperature rises above 15° to 20°C or returning cardiac activity is observed. The regional hypothermia solution around the heart also may be replenished continuously or periodically in order to maintain adequate hypothermia. Suction may be used to remove warmed infusates. An implanted thermistor probe may be used to monitor myocardial temperature. The volumes of solution instilled into the aortic root may vary depending on the duration or type of open heart surgical procedure. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (See PRECAUTIONS ).
Side Effects (Adverse Reactions)
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. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. The buffered solution with added sodium bicarbonate should be cooled to 4°C prior to administration and used within 24 hours of mixing.
Drug 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 ). 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.
Contraindications
CONTRAINDICATIONS Cardioplegic Solution must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP. NOT FOR INTRAVENOUS INJECTION. This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.
Pregnancy and Breastfeeding
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.
Overdosage
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 ).
How Supplied
HOW SUPPLIED Cardioplegic Solution is supplied (without sodium bicarbonate) in a single-dose 1000 mL free flex ® plastic container as follows: Product Code Unit of Use Unit of Sale 258810 NDC 65219-258-01 One 1000 mL free flex ® bag NDC 65219-258-10 Package of 10 free flex ® bags WARNING: Do not use flexible container in series connections. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Manufactured for: Lake Zurich, Illinois 60047 Made in Germany 451744 www.fresenius-kabi.com/us Issued: April 2022 Fresenius Kabi Logo
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.