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PLEGISOL Warnings and Precautions (cardioplegic solution for cardiac perfusion)

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.


PRECAUTIONS

Myocardial temperature should be monitored during surgery to maintain hypothermia.

Continuous electrocardiogram monitoring is essential to detect changes in myocardial activity during the procedure.

Appropriate equipment to defibrillate the heart following cardioplegia should be readily available.

Inotropic support drugs should be available during postoperative recovery.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

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 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of differences in structure, function, and metabolism, clinical myocardial protection strategies and Cardioplegia solutions that are effective in adult hearts may be less effective in the immature heart.

Geriatric Use

Clinical studies of Plegisol did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between older and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.

This product is unique in that there is no hepatic or renal excretion and specific adjustments for dosing in the elderly are not known.

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