POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Plegisol, Cardioplegic Solution. Available dosage form: injection, solution.
Drug Details
- Generic Name
- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, and MAGNESIUM CHLORIDE
- Brand Names
- Plegisol, Cardioplegic Solution
- Application Number
- NDA018608
- Sponsor
- Hospira, Inc.
- NDC Codes
- 2
- Dosage Forms
- INJECTION, SOLUTION
- Routes
- INTRA-ARTERIAL
- Active Ingredients
- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE
Indications and Usage
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.
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.