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TREPROSTINIL
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- In a clinical trial of 240 healthy adult volunteers, single doses of inhaled treprostinil 54 µg (the target clinical dose) and 84 µg (supratherapeutic inhalation dose) prolonged the corrected QTc interval by approximately 10 msec. The QTc effect dissipated rapidly as the concentration of treprostinil decreased. Orenitram has not been evaluated in a thorough QTc study.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
5
24087
Other ADRs
159582
38222005
Odds Ratio = 0.05
Drug Property Information
ATC Code(s):
- B01AC21 - treprostinil
- B01AC - Platelet aggregation inhibitors excl. heparin
- B01A - ANTITHROMBOTIC AGENTS
- B01 - ANTITHROMBOTIC AGENTS
- B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:treprostinil
Active Ingredient UNII:RUM6K67ESG
Drugbank ID:DB00374
PubChem Compound:6918140
PharmGKB:PA164768801
CAS Number:81846-19-7
Dosage Form(s):tablet, extended release
Route(s) Of Administrator:oral
Daily Dose:
- 4.3 mg/day B01AC21
Chemical Structure: 
SMILE Code:
[H][C@]12C[C@@H](O)[C@H](CC[C@@H](O)CCCCC)[C@@]1([H])CC1=C(C2)C(OCC(O)=O)=CC=C1
[H][C@]12C[C@@H](O)[C@H](CC[C@@H](O)CCCCC)[C@@]1([H])CC1=C(C2)C(OCC(O)=O)=CC=C1
Reference
N/A
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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.
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