DIQTA 1.0: Drug-Induced QT Prolongation Atlas

TIZANIDINE

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

PRECAUTIONS
CARDIOVASCULAR
Prolongation of the QT interval and bradycardia were noted in chronic toxicity studies in dogs at doses equal to the maximum human dose on a mg/m 2 basis. ECG evaluation was not performed in the controlled clinical studies. Reduction in pulse rate has been noted in association with decreases in blood pressure in the single dose controlled study (see WARNINGS).

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24076

Other ADRs

6471

38375116

Odds Ratio = 3.942

Drug Property Information

ATC Code(s):

M03BX02 - tizanidine

M03BX - Other centrally acting agents
M03B - "MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS"
M03 - MUSCLE RELAXANTS
M - MUSCULO-SKELETAL SYSTEM

Active Ingredient:TIZANIDINE HYDROCHLORIDE

Active Ingredient UNII:B53E3NMY5C

Drugbank ID:DB00697

PubChem Compound:5487

CTD ID: C023754

PharmGKB:PA451701

CAS Number:51322-75-9

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

12.0 mg/day M03BX02

Chemical Structure:

SMILE Code:
ClC1=C(NC2=NCCN2)C2=NSN=C2C=C1

Reference

1: Potassium wasting nephropathy in the setting of tizanidine overdose: a case report.

[Brucculeri Michael J,Garcia Juan]
J Med Case Rep,2021 May 1;15(1):250. PMID: 33931107

2: Drug safety of macrolide and quinolone antibiotics in a tertiary care hospital: administration of interacting co-medication and QT prolongation.

[Niedrig David,Maechler Sarah,Hoppe Liesa,Corti Natascia,Kovari Helen,Russmann Stefan]
Eur J Clin Pharmacol,2016 Jul;72(7):859-67. PMID: 27023463

3: Drug-induced QT prolongation and sudden death.

[Del Rosario Marc E,Weachter Richard,Flaker Greg C]
Mo Med,Jan-Feb 2010;107(1):53-8. PMID: 20222297

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