Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/809
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Plegisol (Injection, Solution)
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dailymed-instance:dosage |
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 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/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/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.) INSTRUCTIONS FOR USE To Open Tear outer wrap at notch and remove solution
container. If supplemental medication is desired, follow directions
below before preparing for administration. Some opacity of the plastic
due to moisture absorption during the sterilization process may be
observed. This is normal and does not affect the solution quality
or safety. The opacity will diminish gradually. To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, Hospira List
4900, and other supplemental medication, follow directions below before
preparing for administration. To Add Medication Preparation for Administration (Use aseptic technique)
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dailymed-instance:descripti... |
Plegisol (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 Hospira 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 stored
under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter):
Ca2.4 mEq, Mg32 mEq, K16
mEq, Na120 mEq, Cl���160 mEq and bicarbonate (HCO���) 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. Plegisol 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 (CaCl���2 HO), white fragments or granules freely soluble
in water. Magnesium Chloride, USP is chemically
designated magnesium chloride, hexahydrate (MgCl���6 HO), 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 HO. The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride. 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.
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dailymed-instance:clinicalP... |
Plegisol with added sodium bicarbonate when cooled
and instilled into the coronary artery vasculature, causes prompt
arrest of cardiac electromechanical activity, combats intracellular
ion losses and buffers ischemic acidosis. When used with hypothermia
and ischemia, the action may be characterized as cold ischemic potassium-induced
cardioplegia. This is conducive to providing the surgeon with a quiet,
relaxed heart and bloodless field of operation. Calcium (Ca) ion in low concentration is included in
the solution to maintain integrity of cell membrane to ensure that
there is no likelihood of calcium paradox during reperfusion. Magnesium (Mg) ion may help stabilize the
myocardial membrane by inhibiting a myosin phosphorylase, which protects
adenosine triphosphate (ATP) reserves for postischemic activity. The
protective effects of magnesium and potassium have been shown to be
additive. Potassium (K) ion concentration
is responsible for prompt cessation of mechanical myocardial contractile
activity. The immediacy of the arrest thus preserves energy supplies
for postischemic contractile activity in diastole. The chloride (Cl���) and sodium (Na) ions have no
specific role in the production of cardiac arrest. Sodium is essential
to maintain ionic integrity of myocardial tissue. The chloride ions
are present to maintain the electroneutrality of the solution. Added bicarbonate (HCO���) anion is included
as a buffer to render the solution slightly alkaline and compensate
for the metabolic acidosis that accompanies ischemia. Extemporaneous alternative buffering to the described formulation
of this solution is not recommended.
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dailymed-instance:contraind... |
Plegisol must not
be administered without the addition of 8.4% Sodium Bicarbonate Injection,
USP, Hospira List 4900. NOT FOR INTRAVENOUS INJECTION. This solution is only for instillation into cardiac vasculature
after buffering with sodium bicarbonate.
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dailymed-instance:supply |
Plegisol (Cardioplegic Solution)
is supplied (without sodium bicarbonate) in a single-dose 1000-mL
flexible plastic container (List No. 7969, NDC 0409���7969���05). 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. Revised: March, 2007
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dailymed-instance:precautio... |
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.<br/>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.)<br/>Pregnancy Category C.: 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.<br/>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.<br/>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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dailymed-instance:overdosag... |
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.)
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dailymed-instance:genericMe... |
Calcium chloride, magnesium chloride, potassium chloride, and
sodium chloride
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dailymed-instance:fullName |
Plegisol (Injection, Solution)
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dailymed-instance:adverseRe... |
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.
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dailymed-instance:warning |
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.
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dailymed-instance:indicatio... |
Plegisol (Cardioplegic Solution) when suitably buffered
in combination with ischemia and hypothermia is used to induce cardiac
arrest during open heart surgery.
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dailymed-instance:name |
Plegisol
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