DIQTA 1.0: Drug-Induced QT Prolongation Atlas

HYDROCODONE BITARTRATE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIQT concern

Severity Score:2.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
QTc Interval Prolongation
QTc prolongation has been observed with HYSINGLA ER following daily doses of 160 mg [see Clinical Pharmacology (12.2)]. This observation should be considered in making clinical decisions regarding patient monitoring when prescribing HYSINGLA ER in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that are known to prolong the QTc interval.
HYSINGLA ER should be avoided in patients with congenital long QT syndrome. In patients who develop QTc prolongation, consider reducing the dose by 33 – 50%, or changing to an alternate analgesic.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
QTc interval prolongation was studied in a double-blind, placebo- and positive-controlled 3-treatment parallel-group, dose-escalating study of HYSINGLA ER in 196 healthy subjects. QTc interval prolongation was observed following HYSINGLA ER 160 mg per day. The maximum mean (90% upper confidence bound) difference in the QTc interval between HYSINGLA ER and placebo (after baseline-correction) at steady state was 6 (9) milliseconds, 7 (10) milliseconds, and 10 (13) milliseconds at HYSINGLA ER doses of 80 mg, 120 mg and 160 mg respectively. For clinical implications of the prolonged QTc interval, see Warnings and Precautions (5.10).
PATIENT COUNSELING INFORMATION
QTc interval prolongation
Inform patients that QT prolongation has been observed with HYSINGLA ER [see Clinical Pharmacology (12.2)]. HYSINGLA ER should be avoided in patients with congenital long QT syndrome. Instruct patients with a history of congestive heart failure or bradyarrhythmias, and patients at risk for electrolyte abnormalities or who are taking other medications known to prolong the QT interval, that periodic monitoring of electrocardiograms and electrolytes may be necessary during therapy with HYSINGLA ER [see Warnings and Precautions (5.10)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24087

Other ADRs

11539

38370048

Odds Ratio = 0.691

Drug Property Information

ATC Code(s):

R05DA03 - hydrocodone bitartrate

R05DA - Opium alkaloids and derivatives
R05D - "COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS"
R05 - COUGH AND COLD PREPARATIONS
R - RESPIRATORY SYSTEM

Active Ingredient:HYDROCODONE BITARTRATE

Active Ingredient UNII:NO70W886KK

Drugbank ID:DB00956

PubChem Compound:5284569

CTD ID:D006853

PharmGKB:PA449900

CAS Number:125-29-1

Dosage Form(s):tablet, extended release

Route(s) Of Administrator:oral

Daily Dose:

15.0 mg/day R05DA03

Chemical Structure:

SMILE Code:
[H][C@@]12OC3=C(OC)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O

Reference

N/A