DIQTA 1.0: Drug-Induced QT Prolongation Atlas

SILODOSIN

Classification:Ambiguous

Severity Score:1.0

CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
The effect of silodosin on QT interval was evaluated in a double-blind, randomized, active- (moxifloxacin) and placebo-controlled, parallel-group study in 189 healthy male subjects aged 18 to 45 years. Subjects received either silodosin 8 mg, silodosin 24 mg, or placebo once daily for five days, or a single dose of moxifloxacin 400 mg on Day 5 only. The 24 mg dose of silodosin was selected to achieve blood levels of silodosin that may be seen in a “worst-case” scenario exposure (i.e., in the setting of concomitant renal disease or use of strong CYP3A4 inhibitors) [see Contraindications (4), Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. QT interval was measured during a 24-hour period following dosing on Day 5 (at silodosin steady state).
Silodosin was not associated with an increase in individual corrected (QTcI) QT interval at any time during steady state measurement, while moxifloxacin, the active control, was associated with a maximum 9.59 msec increase in QTcI.
There has been no signal of Torsade de Pointes in the post-marketing experience with silodosin outside the United States.

Current Drug

Other Drugs

QT Prolongation

24089

Other ADRs

3205

38378382

Odds Ratio = 1.492

ATC Code(s):

Active Ingredient:SILODOSIN

Active Ingredient UNII:CUZ39LUY82

Drugbank ID:DB06207

PubChem Compound:5312125

CAS Number:160970-54-7

Dosage Form(s):capsule

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
C[C@H](CC1=CC2=C(N(CCCO)CC2)C(=C1)C(N)=O)NCCOC1=CC=CC=C1OCC(F)(F)F

[Manjunatha R,Pundarikaksha H P,Madhusudhana H R,Amarkumar J,Hanumantharaju B K]
Indian J Pharmacol,Mar-Apr 2016;48(2):134-40. PMID: 27127315