Composition: |
Each 50 ml
vial contains:
Aprotinin
........................500.000 KIU. |
 |
| Properties: |
Aprotinin is a natural proteinase
inhibitor obtained from bovine lung. It is a
broad spectrum protease inhibitor which
modulates the systemic inflammatory response
associated with cardiopulmonary bypass
surgery.
Aprotinin through its inhibition of
multiple mediators results in the
attenuation of inflammatory responses,
Fibrinolysis & thrombin generation.
|
| Pharmacokinetics: |
| After I.V. injection, rapid
distribution of Aprotinin occurs into the
total extra cellular space, leading to a
rapid initial decrease in plasma Aprotinin
concentration. Following this phase, a
plasma half-life of about 150 minutes is
observed. Beyond 5 hours after dosing there
is a terminal elimination phase with a
half-life of about 10 hours. After a 30
minutes infusion of 1 million KIU,about 2%
is excreted as unchanged drug. |
| Indications: |
Aprotinin is indicated for prophylactic
use to reduce pre-operative blood loss & the
need for blood transfusion in patients
undergoing cardiopulmonary bypass in the
course of coronary artery bypass graft
surgery.
|
| Contraindications: |
Hypersensitivity to Aprotinin.
|
| Use during pregnancy &
Lactation: |
►There
are no adequate & well-controlled studies in
pregnant women, so this drug should be used
during pregnancy only if clearly needed.
►It is not
applicable for nursing mother .
|
| Drug interactions: |
|
Aprotinin may inhibit the effects of
fibrinolytic agents. |
| Dosage & route of
administration & duration: |
►Test
dose......................................1
ml (1.4 mg or 10.000 KIU)
Should be given I.V at least 10 minutes
before the loading dose.
►Loading
dose.................................200
ml (280 mg or 2 million KIU)
Given slowly over 20-30 minutes after
induction of anesthesia.
►Pump prime
dose..........................200 ml
(280 mg or 2 million KIU)
Added to the priming fluid of the
cardiopulmonary bypass circuit.
►Constant
infusion dose...................50 mI /
hour (70 mg / hour, or 500,000 KIU / hour)
|
| Adverse
effects: |
Aprotinin is generally well tolerated,
the following adverse effects occurred in
less than 2% of patients as: Thrombosis,
shock , cerebrovasular accidents,
thrombophlebitis, lung edema, pulmonary
embolus & kidney failure.
|
| Storage: |
Should be stored between 2°
& 25°C ( avoid freezing ) .
Keep medicine out of reach of children.
|
| Presentation: |
50 ml vial.
|
