Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/491
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Cardioplegic (Injection, Solution)
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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 AbbottList 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 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
balanced electrolyte replacement solution or Ringer's
Injection 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
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dailymed-instance:descripti... |
Baxter's
Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic,
formulation of electrolytes in Water for Injection, USP. 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 USP 17.6 mg, Magnesium
Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg, and
Sodium Chloride USP 643 mg, in Water for Injection, USP. May contain HCl
and/or NaOH for pH adjustment. Electrolyte content per liter (not
including ions for pH adjustment): Sodium (Na+) 110 mEq; Magnesium
(Mg++) 32 mEq; Potassium (K+) 16 mEq; Calcium (Ca++) 2.4 mEq; Chloride
(Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8
(3.5 - 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 AbbottList 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 addedjust 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): Na+ 120 mEq, Mg++ 32
mEq, K+ 16 mEq, Ca++ 2.4 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. 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
(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
polyvinylchloride. Water can permeate from inside the container into the
overwrap but not in amounts sufficient to effect the solution
significantly. Solutions inside the plastic container also can leach out
certain of its chemical components in very small amounts before the
expiration period is attained. However, the safety of the plastic has
been confirmed by tests in animals according to USP biological standards
for plastic containers.
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dailymed-instance:clinicalP... |
Cardioplegic
solution 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 the described formulation of this solution is not
recommended.
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Baxter's Cardioplegic Solution must
not be administered without the addition of 8.4% Sodium Bicarbonate,
Injection, USP, Abbott 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 |
Baxter's
Cardioplegic Solution is supplied (without sodium bicarbonate) in a
single-dose 1000 mL flexible plastic container as follows: 2B1462 NDC
0338-0341-04 WARNING: Do not use
flexible container in series connections. Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. Protect from freezing. It is recommended that the product be
stored at room temperature (25��C); however, brief exposure up
to 40��C does not adversely affect the product. For Product
Information Call 1-800-933-0303 Baxter Healthcare
Corporation Deerfield, IL 60015
USA *Bar Code Position
Only 071912303 ��Copyright 1997, Baxter Healthcare Corporation. All rights reserved. 07-19-12-303 Rev. June 2000
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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. .<br/>Pregnancy Category
C:: 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.<br/>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.
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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 Dihydrate, Magnesium Chloride
Hexahydrate, Potassium Chloride and Sodium
Chloride
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dailymed-instance:fullName |
Cardioplegic (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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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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Baxter's
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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Cardioplegic
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