Drug Interaction:
Drugs affecting haemostasis Coagulation assays based on APTT
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Drotecoglin Alpha For severe sepsis 23-07-2002
Severe sepsis with multiorgan failure
Adverse Reaction:
Ecchymosis g i bleeding Serious bleeding events Possible antibody formation
Contra-Indications:
Not indicated for patients with single organ dysfunction Active internal bleeding Recent ( less than 3 mths ) haemorrhage, stroke Recent ( less thsan 2 mths ) intracanial/intrspinal surgery Severe head trauma Tauma patients with increased risk of life threatening bleeding Epidural catheter Special Precautions- Recent GI bleeding ( less than 6 weeks ) Thrombolytic therapy ( less than 3 days ) Oral anticoagulants Glycoprotein IIb/IIIa inhibitors Aspirin more than 650mg/day Other platelet inhibitors ( less than 7 days ) Concurrent heparin Chronic severe hepatic disease Pregnancy Lactation
Dosages/ Overdosage Etc:
Severe sepsis with multiorgan failure 24mcg/kg/hour as continuous i v infusion for 96 hours total duration Therapy to be started within 24 hours of organ failure Not recommended for patients under 18 years
Pregnancy and lactation:
Use contraindicated Observe caution
Manufacturer Details