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TEDIZOLID PHOSPHATE
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 randomized, positive- and placebo-controlled crossover thorough QTc study, 48 enrolled subjects were administered a single oral dose of SIVEXTRO at a therapeutic dose of 200 mg, SIVEXTRO at a supratherapeutic dose of 1200 mg, placebo, and a positive control; no significant effects of SIVEXTRO on heart rate, electrocardiogram morphology, PR, QRS, or QT interval were detected. Therefore, SIVEXTRO does not affect cardiac repolarization.
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):
- J01XX11 - tedizolid phosphate
- J01XX - Other antibacterials
- J01X - OTHER ANTIBACTERIALS
- J01 - ANTIBACTERIALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:tedizolid phosphate
Active Ingredient UNII:O7DRJ6R4DW
Drugbank ID:DB09042
PubChem Compound:11476460
CTD ID:C515040
CAS Number:856867-55-5
Dosage Form(s):injection, powder, lyophilized, for solution; tablet, film coated
Route(s) Of Administrator:intravenous; oral
Daily Dose:
- 200.0 mg/day J01XX11
Chemical Structure: 
SMILE Code:
CN1N=NC(=N1)C1=CC=C(C=N1)C1=CC=C(C=C1F)N1C[C@H](COP(O)(O)=O)OC1=O
CN1N=NC(=N1)C1=CC=C(C=N1)C1=CC=C(C=C1F)N1C[C@H](COP(O)(O)=O)OC1=O
Reference
1: Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study.
[Flanagan Shawn,Litwin Jeffrey,Fang Edward,Prokocimer Philippe]Int J Antimicrob Agents,2016 Jul;48(1):33-40. PMID: 27342387
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