DIQTA 1.0: Drug-Induced QT Prolongation Atlas

PLAZOMICIN

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
Cardiac Electrophysiology
The effect of ZEMDRI on the QTc interval was evaluated in a Phase 1 randomized, placebo and positive controlled, double-blind, single-dose, crossover thorough QTc study in 56 healthy adult subjects. At a single dose of 20 mg/kg (1.3 times the maximum recommended dose), ZEMDRI did not prolong the QTc interval to any clinically relevant extent.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

38381587

Odds Ratio = N/A

Drug Property Information

ATC Code(s):

J01GB14 - plazomicin

J01GB - Other aminoglycosides
J01G - AMINOGLYCOSIDE ANTIBACTERIALS
J01 - ANTIBACTERIALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

Active Ingredient:plazomicin

Active Ingredient UNII:LYO9XZ250J

Drugbank ID:DB12615

PubChem Compound:42613186

CTD ID:C550938

PharmGKB:

CAS Number:1154757-24-0

Dosage Form(s):injection

Route(s) Of Administrator:intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
CN[C@@H]1[C@@H](O)[C@@H](O[C@H]2[C@@H](C[C@H](N)[C@@H](O[C@H]3OC(CNCCO)=CC[C@H]3N)[C@@H]2O)NC(=O)[C@@H](O)CCN)OC[C@]1(C)O

Reference

1: A Phase 1 Study of Intravenous Plazomicin in Healthy Adults to Assess Potential Effects on the QT/QTc Interval, Safety, and Pharmacokinetics.

[Gall Jonathan,Choi Taylor,Riddle Valerie,Van Wart Scott,Gibbons Jacqueline A,Seroogy Julie]
Clin Pharmacol Drug Dev,2019 Nov;8(8):1032-1041. PMID: 30650259

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