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Aprotinin information from DrugsUpdate  

See Available Brands of Aprotinin in India

P - Cautioned while taken during pregnancy
L - Cautioned while taken during lactation
LI - Lab*

Aprotinin, also known as bovine pancreatic trypsin inhibitor, BPTI (Trasylol, Bayer) is a protein, that is used as medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down of fibrinolysis, the process that leads to the breakdown of blood clots. The aim in its use is to decrease the need for blood transfusions during surgery, as well as end-organ damage due to hypotension (low blood pressure) as a result of marked blood loss. The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death[1]; this was confirmed by follow-up studies. Trasylol was entirely and permanently withdrawn in May 2008 (except for very restricted research use).

Pharmacodynamics

Pharmacokinetics

Aprotinin is a polypeptide and inhibits proteolytic enzymes including trypsin, chymotrypsin, kallikrein and plasmin. Inhibition of plasmin inhibits fibrinolysis and reduces operative blood loss.
Metabolism: Inactivated in the GI tract.
Excretion: Via urine as inactive degradation products; 5-10 hr (elimination half-life).

Aprotinin Indications / Aprotinin Uses

In open heart surgery, haemorrhage

Aprotinin Adverse Reactions / Aprotinin Side Effects

Fever and nausea. GI disturbances. Hypersensitivity or pseudo-allergic reactions may occur after 1st dose or thereafter e.g. skin rashes and eruptions, tachycardia, pallor or cyanosis, dyspnoea and anaphylactic shock.
Potentially Fatal: Fatal anaphylactic reactions.

Special Precautions

Test dose should be administered to all patients at least 10 minutes before loading dose to assess for risk of hypersensitvity. Neonates and children. Greater risk of anaphylactic reactions upon re-exposure within 12 mth of previous use. Renal impairment. Pregnancy, lactation. Activated clotting time may not be a reliable method to monitor heparin therapy when on aprotinin treatment.

Other Drug Interactions

May reduce hypotensive action of captopril and enalapril. Risk of apnoea when used with neuromuscular blockers. Risk of fatal thrombotic complications when used with tretinoin.

Other Interactions

Information Not Available

Dosage

Intravenous
Haemorrhage
Adult: Admin a test dose of 10,000 KIU at least 10 minutes before starting treatment. Loading dose: 500,000-1,000,000 KIU, given by slow inj or infusion (max rate: 100,000 KIU/minute) with the patient in supine position, may continue with 200,000 KIU/hr until the haemorrhage is controlled. Doses to be given via central venous line.
Child: 1 mth-18 yr: Test dose of 200 KIU/kg, followed after 10 minutes by a dose of 10,000 KIU/kg given over 20 minutes, then continuous infusion of 3,000 KIU/kg/hr until bleeding is controlled.
Intravenous
Open heart surgery
Adult: Admin a test dose of 10,000 KIU at least 10 minutes before starting treatment. Loading dose: 2,000,000 KIU over 20-30 minutes after induction of anaesthesia but before incision or reopening of wound, followed by continuous infusion of 500,000 KIU/hr until the end of the surgery. Add an additional dose of 2,000,000 KIU into the prime volume of the extracorporeal circuit. Doses to be given via central venous line. For patients with septic endocarditis, add a dose of 3 000 000 KIU into the prime volume of the circuit; may continue infusion into the early postoperative period. Usual total amount ≤7 000 000 KIU.

Incompatibility: Incompatible with corticosteroids, heparin, tetracyclines, and nutrient solutions containing amino acids or fat emulsions.

Food(before/after)

Information Not Available

List of Contraindications

Aprotinin and Pregnancy

Caution when used during pregnancy
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Aprotinin and Lactation

Caution when used during lactation

Aprotinin and Children

Information Not Available

Aprotinin and Geriatic

Information Not Available

Aprotinin and Other Contraindications

Hypersensitivity

Storage

Intravenous: Store at 2-25°C

Lab interference

Intravenous: Store at 2-25°C

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