DIQTA 1.0: Drug-Induced QT Prolongation Atlas

LINEZOLID

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Ambiguous

Severity Score:1.0

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

CLINICAL PHARMACOLOGY
Pharmacodynamics
In a randomized, positive- and placebo-controlled crossover thorough QT study, 40 healthy subjects were administered a single ZYVOX 600 mg dose via a 1 hour IV infusion, a single ZYVOX 1,200 mg dose via a 1 hour IV infusion, placebo, and a single oral dose of positive control. At both the 600 mg and 1,200 mg ZYVOX doses, no significant effect on QTc interval was detected at peak plasma concentration or at any other time.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24018

Other ADRs

25177

38356410

Odds Ratio = 4.694

Drug Property Information

ATC Code(s):

J01XX08 - linezolid

J01XX0 -
J01XX - Other antibacterials
J01X - OTHER ANTIBACTERIALS
J01 - ANTIBACTERIALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

Active Ingredient:LINEZOLID

Active Ingredient UNII:ISQ9I6J12J

Drugbank ID:DB00601

PubChem Compound:441401

CTD ID:D000069349

PharmGKB:PA450233

CAS Number:165800-03-3

Dosage Form(s):injection, solution; suspension; tablet, film coated

Route(s) Of Administrator:intravenous; oral

Daily Dose:

1200.0 mg/day J01XX08

Chemical Structure:

SMILE Code:
CC(=O)NC[C@H]1CN(C(=O)O1)C1=CC(F)=C(C=C1)N1CCOCC1

Reference

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