DIQTA 1.0: Drug-Induced QT Prolongation Atlas

FOSPHENYTOIN SODIUM

Classification:Most-DIQT concern

Severity Score:4.0

WARNINGS AND PRECAUTIONS
Cardiovascular Risk Associated with Rapid Infusion
Rapid intravenous administration of CEREBYX increases the risk of adverse cardiovascular reactions, including severe hypotension and cardiac arrhythmias. Cardiac arrhythmias have included bradycardia, heart block, QT interval prolongation, ventricular tachycardia, and ventricular fibrillation which have resulted in asystole, cardiac arrest, and death. Severe complications are most commonly encountered in critically ill patients, elderly patients, and patients with hypotension and severe myocardial insufficiency. However, cardiac events have also been reported in adults and children without underlying cardiac disease or comorbidities and at recommended doses and infusion rates.
ADVERSE REACTIONS
Clinical Trials Experience
Cardiovascular: Frequent: hypertension; Infrequent: cardiac arrest, migraine, syncope, cerebral hemorrhage, palpitation, sinus bradycardia, atrial flutter, bundle branch block, cardiomegaly, cerebral infarct, postural hypotension, pulmonary embolus, QT interval prolongation, thrombophlebitis, ventricular extrasystoles, congestive heart failure.

Current Drug

Other Drugs

QT Prolongation

24090

Other ADRs

2144

38379443

Odds Ratio = 1.487

ATC Code(s):

Active Ingredient:FOSPHENYTOIN SODIUM

Active Ingredient UNII:7VLR55452Z

Drugbank ID:DB00252

PubChem Compound:1775

CTD ID:D010672

PharmGKB:PA450947

CAS Number:57-41-0

Dosage Form(s):injection, solution

Route(s) Of Administrator:intramuscular; intravenous

Daily Dose:

Chemical Structure:

SMILE Code:
O=C1NC(=O)C(N1)(C1=CC=CC=C1)C1=CC=CC=C1

N/A