Cardioplegic Solution

(Potassium Chloride, Sodium Chloride, Calcium Chloride, And Magnesium Chloride)

Check Drug InteractionsCheck known drug interactions.

Cardioplegic Solution Prescribing Information

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/m²/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/m²/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

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 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.

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 Cardioplegic Solution 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.

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.

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

Flexible Plastic Container (

free

flex

® bag)

Do not remove solution container from its overwrap until immediately before use.

The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling.

To Open

Always inspect the solution container before and after removal from the overwrap.
Place the solution container on a clean, flat surface. Remove the solution container from the overwrap.
Check the solution container for leaks by squeezing firmly. If leaks are found, discard.

To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, and if other supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

Identify WHITE Additive Port with arrow pointing toward solution container.
Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward solution container.
Hold base of WHITE Additive Port.
Using aseptic technique, insert needle (18 to 23 gauge) through the center of WHITE Additive Port's septum and inject additives.
Mix solution container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

Close the flow control clamp of the administration set.
Immediately before inserting the administration set, break off BLUE Infusion Port Cap with the arrow pointing away from solution container.
Hold the base of BLUE Infusion Port, twist and push the spike until the spike is fully inserted.
NOTE:
See full directions accompanying administration set.
The BLUE infusion port contains a self‐sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.
Suspend solution container from hanger hole.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Attach aortic infusion device to set.
Open flow control clamp to expel air from set and aortic infusion device. Close clamp.
Position aortic infusion device to introduce solution into aortic root.
Regulate rate of administration with flow control clamp.
For Single use Only. Discard unused portion.

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

Flexible Plastic Container (

free

flex

® bag)

Do not remove solution container from its overwrap until immediately before use.

The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling.

To Open

Always inspect the solution container before and after removal from the overwrap.
Place the solution container on a clean, flat surface. Remove the solution container from the overwrap.
Check the solution container for leaks by squeezing firmly. If leaks are found, discard.

To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, and if other supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication

Identify WHITE Additive Port with arrow pointing toward solution container.
Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward solution container.
Hold base of WHITE Additive Port.
Using aseptic technique, insert needle (18 to 23 gauge) through the center of WHITE Additive Port's septum and inject additives.
Mix solution container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

Close the flow control clamp of the administration set.
Immediately before inserting the administration set, break off BLUE Infusion Port Cap with the arrow pointing away from solution container.
Hold the base of BLUE Infusion Port, twist and push the spike until the spike is fully inserted.
NOTE:
See full directions accompanying administration set.
The BLUE infusion port contains a self‐sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.
Suspend solution container from hanger hole.
Squeeze and release drip chamber to establish proper fluid level in chamber.
Attach aortic infusion device to set.
Open flow control clamp to expel air from set and aortic infusion device. Close clamp.
Position aortic infusion device to introduce solution into aortic root.
Regulate rate of administration with flow control clamp.
For Single use Only. Discard unused portion.

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.

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 (HCO₃‾) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered.

The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded.

Cardioplegic Solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia.

Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl₂• 2 H₂O), white fragments or granules freely soluble in water.

Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl₂• 6 H₂O), deliquescent flakes or crystals very soluble in water.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H₂O.

The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (

free

flex

^® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Report Adverse Event

Cardioplegic Solution

Cardioplegic Solution Prescribing Information

Cardioplegic Solution PubMed™ News