Drug Interaction:
None reported
Indication:
Platelet aggregation inhibition
To reduce risk of MI in patients with unstable angina scheduled for coronary angioplasty or
who do not respond to conventional therapy
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Abciximab Biopharmaceuticals Centocor Inc 23-6-2015
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref - IDMA Publication)
Name of Drug Indication Date of Approval
Abciximab Adjunct to PTCA 02-05-1997
Adverse Reaction:
Bleeding, thrombocytopenia, development of human anti-chimeric antibody (HACA),
diarrhea, constipation,
hemolytic anemia, petechiae,
abnormal thinking, dizziness,
coma, brain ischemia, insomnia
Contra-Indications:
Because abciximab increases risks of bleeding, it is contraindicated in- active internal bleeding, GI or GU bleeding of clinical significance, major surgery or trauma, intracranial neoplasm, severe uncontrolled hypertension.
Special precautions:
Monitoring before infusion of abciximab, measure platelet count, use caution when it is used with other drugs that affect hemostatis.
Thrombocytopenia- monitor platelet count prior to treatment
Dosages/ Overdosage Etc:
Approved by FDA on December 22, 1994
Indications:
Platelet aggregation inhibition
Dosage:
Abciximab is intended for use in patients undergoing PTCA. The safety and efficacy of abciximab have only been investigated with concomittant administration of heparin and aspirin.
Recommended dose- IV bolus of 0.25mg/kg administered 10 to 60 minutes before the start PTCA followed by a continous IV infusion of 10mcg/min for 12 hours
Missed dose :
1. If you miss a dose of this medicine, and remember within 6 hours of take it as soon as possible unless the dose is less than 4 hours.
2. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Other Information:
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Abciximab Biopharmaceuticals Centocor Inc 23-6-2015
EVIDENCE BASED MEDICINE (MIMS April 2003)
Stroke prevention Comparative effectiveness of various interventions
PRIOR TO STROKE OR TRANSIENT ISCHAEMIC ACCIDENT (TIA)
Beneficial
1. Antiplatelet treatment
2. Cholestrerol reduction (for those patients who also have coronary heart disease)
3. Carotid endarterectomy (in patients with severe symptomatic carotid artery stenosis)
Unknown effectiveness
1. Cholesterol reduction (for patients without CHD)
2. Blood pressure reduction
3. Carotid endarterectomy (in patients with severe symptomatic carotid artery stenosis)
4. Catotid angioplasty Likely to ineffective or even harmful
Oral anticoagulation ATRIAL FIBRILLATION AND A PRIOR STROKE OR TIA Beneficial 1. Oral anticoagulation
2. Aspirin for patients with contraindications to an anticoagulant
ATRIAL FIBRILLATION BUT NO OTHER MAJOR RISK FACTORS FOR STROKE
Likely to be beneficial.
KEY POINTS
In patients with a prior stroke or TIA
1. Insufficient evidence to support routine blood presure reduction
2. Statins may prevent stroke in those with a history of CHD but evidence inconclusive in those with no history of CHD.
3. Routine use of prolonged anti-platelet treatment beneficial ( if no contraindication)
4. Aspirin 75mg daily as effective as higher doses. No evidence that any other antiplatelet regimen is definitely superior in the prevention of vascular events. Clopidogrel or the combination of asprin and dipyridamole are safe and effective (but more costly) alternatives to aspirin
5. No evidence of benefit from anti-coagulation in patients in sinus rhythm, but an increased risk of serious bleeding
6. Carotid endarterectomy reduces risk of major stroke in patients with severe carotid stenosis provided the risks of imaging and surgery are small.
7. Percutaneous transluminal angioplastys role has not been evaluated adequately In patients with atrial fibrillation and a pror stroke or TIA
-
Anticoagulants reduce risk of stroke, provided there is low risk of bleeding and careful monitoring
-
Aspirin reduces risk of stroke but less effectively than anticoagulants. These findings support the use of aspirin among patients with atrial fibrillation and contra-indication to anticoagulants In patients with atrial fibrillation but neither major risk factors for stroke
-
Anticoagulants are of net benefit, if low risk of bleeding and careful monitoring
-
Aspirin is a reasonable alternative in patients with contra-indications to anticoagulants
Patient Information:
1.Advice patients that abciximab may reduce the number of blood cells that are needed
for clotting.
2.Patients should report any unusual bleeding, bruising, or blood in stools
Pharmacology/ Pharmacokinetics:
Pharmacology:
Abciximab is the Fab fragment of the chimeric human-murine monoclonal antibody 7ES. The drug inhibits platelet aggregation by preventing the binding of fibinogen von Willbrand factor and other adhesive molecules to receptor sites on activated platelets
Pharmacokinetics:
Following IV bolus admin, free plasma concentrations of abciximab decreases rapidly with an initial half-life of less than 10 minutes and a second phase half-life of about 30 minutes.
Pregnancy and lactation:
Pregnancy:
Give to a pregnant woman only if clearly needed.
Lactation:
Excercise caution when abciximab is administered to a nursing woman.