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RETEPLASE


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 in patients treated with thrombolytic agents. 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, and rhabdomyolysis and can be fatal. It is also 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
2
42910
Other ADRs
1118
14116161

Odds Ratio = 0.589

Drug Property Information



ATC Code(s):
  • B01AD07 - reteplase
    • B01AD - Enzymes
    • B01A - ANTITHROMBOTIC AGENTS
    • B01 - ANTITHROMBOTIC AGENTS
    • B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:reteplase
Active Ingredient UNII:DQA630RIE9
Drugbank ID:DB00015
PubChem Compound:N/A
CAS Number:133652-38-7
Dosage Form(s):kit
Route(s) Of Administrator:-
Daily Dose:
  • 20U B01AD07
Chemical Structure:
SMILE Code:
-

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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