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OMADACYCLINE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically relevant QTc prolongation was observed at the maximum recommended dose of omadacycline.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
1
24091
Other ADRs
350
38381237
Odds Ratio = 4.552
Drug Property Information
ATC Code(s):
- J01AA15 - omadacycline
- J01AA - Tetracyclines
- J01A - TETRACYCLINES
- J01 - ANTIBACTERIALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:omadacycline
Active Ingredient UNII:090IP5RV8F
Drugbank ID:DB12455
PubChem Compound:54697325
CTD ID: C000591640
CAS Number:389139-89-3
Dosage Form(s):injection, powder, lyophilized, for solution; tablet, film coated
Route(s) Of Administrator:intravenous; oral
Daily Dose:
- 300.0 mg/day J01AA15
Chemical Structure: 
SMILE Code:
[H][C@@]12CC3=C(C=C(CNCC(C)(C)C)C(O)=C3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2)N(C)C
[H][C@@]12CC3=C(C=C(CNCC(C)(C)C)C(O)=C3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2)N(C)C
Reference
N/A
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