DIQTA 1.0: Drug-Induced QT Prolongation Atlas

GADOBENATE DIMEGLUMINE

Classification:Ambiguous

Severity Score:1.0

WARNINGS AND PRECAUTIONS
Cardiac Arrhythmias
Cardiac arrhythmias have been observed in patients receiving MultiHance in clinical trials [see Adverse Reactions (6.1)]. Assess patients for underlying conditions or medications that predispose to arrhythmias.
A double-blind, placebo-controlled, 24-hour post dose continuous monitoring, crossover study in 47 subjects evaluated the effect of 0.2 mmol/kg MultiHance on ECG intervals, including QTc. The average changes in QTc values compared with placebo were minimal (<5 msec). QTc prolongation between 30 and 60 msec were noted in 20 subjects who received MultiHance vs. 11 subjects who received placebo. Prolongations ≥61 msec were noted in 6 subjects who received MultiHance and in 3 subjects who received placebo. None of these subjects had associated malignant arrhythmias. The effects on QTc by MultiHance dose, other drugs, and medical conditions were not systematically studied.
ADVERSE REACTIONS
Clinical Trials Experience
Investigations: Nonspecific changes in laboratory tests (including hematology, blood chemistry, liver enzymes and urinalysis), blood pressure and electrocardiogram parameters (including PR, QRS and QT intervals and ST-T segment changes).

Current Drug

Other Drugs

QT Prolongation

24092

Other ADRs

267

38381320

Odds Ratio = 0.0

ATC Code(s):

Active Ingredient:gadobenate dimeglumine

Active Ingredient UNII:3Q6PPC19PO

Drugbank ID:DB14578

PubChem Compound:N/ADIR Classification

CTD ID:C064572

PharmGKB:

CAS Number:22541-19-1

Dosage Form(s):injection, solution

Route(s) Of Administrator:intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
[Gd+3]

N/A