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ALTEPLASE
DIR Classification
Classification:Most-DIR concern
Severity Score:4
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- Cholesterol Embolization
- Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. Cholesterol embolism may present with livedo reticularis, "purple toe" syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, or rhabdomyolysis and can be fatal. It is associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
5
42907
Other ADRs
7817
14109462
Odds Ratio = 0.211
Drug Property Information
ATC Code(s):
- S01XA13 - alteplase
- S01XA - Other ophthalmologicals
- S01X - OTHER OPHTHALMOLOGICALS
- S01 - OPHTHALMOLOGICALS
- S - SENSORY ORGANS
- B01AD02 - alteplase
- B01AD - Enzymes
- B01A - ANTITHROMBOTIC AGENTS
- B01 - ANTITHROMBOTIC AGENTS
- B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:alteplase
Active Ingredient UNII:1RXS4UE564
Drugbank ID:DB00009
PubChem Compound:N/A
CAS Number:105857-23-6
Dosage Form(s):kit
Route(s) Of Administrator:-
Daily Dose:
- 100.0 mg/day B01AD02
Chemical Structure: 
SMILE Code:
-
-
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
N/ADisclaimer:
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