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ORITAVANCIN


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • In a thorough QTc study of 135 healthy subjects at a dose 1.3 times the 1200 mg recommended dose, ORBACTIV did not prolong the QTc interval to any clinically relevant extent.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587

Odds Ratio = N/A

Drug Property Information



ATC Code(s):
  • J01XA05 - oritavancin
    • J01XA0 -
    • J01XA - Glycopeptide antibacterials
    • J01X - OTHER ANTIBACTERIALS
    • J01 - ANTIBACTERIALS FOR SYSTEMIC USE
    • J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:ORITAVANCIN
Active Ingredient UNII:PUG62FRZ2E
Drugbank ID:DB04911
PubChem Compound:16136912
CTD ID: C100708
PharmGKB:
CAS Number:171099-57-3
Dosage Form(s):injection, powder, lyophilized, for solution
Route(s) Of Administrator:intravenous
Daily Dose:
Chemical Structure:
SMILE Code:
CN[C@H](CC(C)C)C(=O)N[C@@H]1[C@H](O)C2=CC=C(OC3=C(O[C@@H]4O[C@H](CO)[C@@H](O)[C@H](O)[C@H]4O[C@H]4C[C@](C)(NCC5=CC=C(C=C5)C5=CC=C(Cl)C=C5)[C@@H](O)[C@H](C)O4)C4=CC(=C3)[C@@H](NC(=O)[C@H](CC(N)=O)NC1=O)C(=O)N[C@@H]1C3=CC(=C(O)C=C3)C3=C(O)C=C(O)C=C3[C@H](NC(=O)[C@@H](NC1=O)[C@H](O[C@H]1C[C@](C)(N)[C@@H](O)[C@H](C)O1)C1=CC(Cl)=C(O4)C=C1)C(O)=O)C(Cl)=C2

Reference

1: Oritavancin, a new lipoglycopeptide antibiotic: results from a thorough QT study.

[Darpo Borje,Lee Sun K,Moon Thomas E,Sills Nancy,Mason Jay W]
J Clin Pharmacol,2010 Aug;50(8):895-903. PMID: 20484618

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