Cardioplegic 17.6 mg/100mL
Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride · SOLUTION · Baxter Healthcare Corporation
Cardioplegic is a solution containing calcium chloride, magnesium chloride, potassium chloride and sodium chloride at 17.6 mg/100mL, taken intra-arterial. Manufactured by Baxter Healthcare Corporation.
Key Facts
- Brand Name
- Cardioplegic
- Generic Name
- Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride
- NDC Code (Product)
0338-0341- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 17.6 mg/100mL
- Dosage Form
- SOLUTION
- Route
- INTRA-ARTERIAL
- Marketing Status
- Application #
- ANDA075323
- Marketing Start
- 04/21/2000
Recall History
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & 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 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 …
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. 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.
Contraindications
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.
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.
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.
Frequently Asked Questions
What is Cardioplegic used for?
Cardioplegic contains Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride. It is a solution taken intra-arterial. Consult your doctor for specific uses.
Is Cardioplegic a controlled substance?
Cardioplegic is not classified as a controlled substance by the DEA.
What is the generic name for Cardioplegic?
The generic name for Cardioplegic is Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride. There are no other listed brand versions of Calcium Chloride, Magnesium Chloride, Potassium Chloride and Sodium Chloride.
What is the NDC code for Cardioplegic 17.6 mg/100mL?
The NDC (National Drug Code) for Cardioplegic 17.6 mg/100mL is 0338-0341, listed by Baxter Healthcare Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)