A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Trasylol Indications, Dosage, Storage, Stability - Aprotinin
Trasylol Indications, Dosage, Storage, Stability - Aprotinin
INDICATIONS
Trasylol is indicated for prophylactic
use to reduce perioperative
blood loss and the need for blood
transfusion in patients
undergoing cardiopulmonary bypass in the course of coronary
artery bypass
graft surgery.
DOSAGE AND ADMINISTRATION
Trasylol given prophylactically in both Regimen A and Regimen B (half
Regimen A) to patients undergoing CABG
surgery significantly reduced
the donor blood transfusion
requirement relative to placebo
treatment. In low risk patients
there is no difference in efficacy
between regimen A and B. Therefore,
the dosage used (A vs. B) is
at the discretion of the practitioner. Trasylol is supplied as a solution
containing 10,000 KIU/mL, which is equal to 1.4 mg/mL. All intravenous
doses of Trasylol should be administered through a central
line. DO NOT ADMINISTER ANY OTHER DRUG USING THE SAME LINE. Both
regimens include a 1 mL test
dose, a loading dose, a dose
to be added to the priming fluid
of the ardiopulmonary bypass
circuit ( "pump prime"
dose), and a constant infusion
dose. Regimens A and B (both incorporating a 1 mL test
dose) are described in the table below:
| |
TEST DOSE
|
LOADING DOSE
|
"PUMP PRIME" DOSE
|
CONSTANT INFUSION DOSE
|
| TRASYLOL |
1 mL
|
200 mL
|
200 mL
|
50 mL/hr
|
| REGIMEN A |
(1.4 mg, or
10,000 KIU)
|
(280 mg, or
2.0 million KIU)
|
(280 mg, or
2.0 million KIU)
|
(70 mg/hr, or 500,000 KIU/hr)
|
| TRASYLOL |
1 mL
|
100 mL
|
100 mL
|
25 mL/hr
|
| REGIMEN B |
(1.4 mg, or
10,000 KIU)
|
(140 mg, or
1.0 million KIU)
|
(140 mg, or
1.0 million KIU)
|
(35 mg/hr, or
250,000 KIU/hr)
|
The 1 mL test dose
should be administered intravenously at least 10 minutes before the loading
dose. With the patient in
a supine position, the loading
dose is given slowly over 20-30
minutes after induction
of anesthesia but prior to sternotomy. In
patients with known previous exposure to Trasylol, the loading
dose should be given just prior
to cannulation. When the loading
dose is complete, it is followed
by the constant infusion
dose, which is continued until surgery
is complete and the patient
leaves the operating room. The "pump prime" dose
is added to the priming fluid of the cardiopulmonary
bypass circuit, by replacement
of an aliquot of the priming fluid,
prior to the institution of cardiopulmonary
bypass. Total doses of more than 7 million KIU have not been studied in
controlled trials.
Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to
administration whenever
solution and container permit.
Discard any unused portion.
Renal and Hepatic Impairment
No formal studies of the pharmacokinetics
of aprotinin in patients
with preexisting renal insufficiency
have been conducted. However, in the placebo-controlled clinical trials
conducted in the United States, patients with mildly elevated pretreatment
serum creatinine
levels did not have a notably higher incidence of clinically significant
post-treatment elevations in serum
creatinine following either Trasylol Regimen A or Regimen B compared to
administration of the placebo
regimen. Changes in aprotinin
pharmacokinetics
with age or impaired renal function
are not great enough to require any dose
adjustment. No pharmacokinetic data from patients with pre-existing hepatic
disease treated with Trasylol are available.
HOW SUPPLIED
|
Size
|
Strength
|
NDC
|
|
100 mL vials
|
1,000,000 KIU
|
0026 8196 36
|
|
200 mL vials
|
2,000,000 KIU
|
0026 8197 63
|
STORAGE Trasylol should be stored between 2o and 25o
C (36o-77o F)
Protect from freezing.
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