DIQTA 1.0: Drug-Induced QT Prolongation Atlas

CIPROFLOXACIN

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIQT concern

Severity Score:4.0

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

WARNINGS AND PRECAUTIONS
Prolongation of the QT Interval
Some fluoroquinolones, including ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia. Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including ciprofloxacin.
Avoid ciprofloxacin in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. Elderly patients may also be more susceptible to drug-associated effects on the QT interval [see ADVERSE REACTIONS (6.2), USE IN SPECIFIC POPULATIONS (8.5)].
DRUG INTERACTIONS
ADVERSE REACTIONS
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS (5.12)]
[Postmarketing Experience]
PATIENT COUNSELING INFORMATION
Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
who are elderly
with a family history of prolonged QT interval
with low blood potassium (hypokalemia)
who take certain medicines to control heart rhythm (antiarrhythmics)
USE IN SPECIFIC POPULATIONS
Geriatric Use
In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see WARNINGS AND PRECAUTIONS (5.12)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

213

23879

Other ADRs

128160

38253427

Odds Ratio = 2.663

Drug Property Information

ATC Code(s):

J01MA02 - ciprofloxacin

J01MA - Fluoroquinolones
J01M - QUINOLONE ANTIBACTERIALS
J01 - ANTIBACTERIALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

S01AE03 - ciprofloxacin

S01AE -
S01A - ANTIINFECTIVES
S01 - OPHTHALMOLOGICALS
S - SENSORY ORGANS

S02AA15 - ciprofloxacin

S02AA - Antiinfectives
S02A - ANTIINFECTIVES
S02 - OTOLOGICALS
S - SENSORY ORGANS

S03AA07 - ciprofloxacin

S03AA - Antiinfectives
S03A - ANTIINFECTIVES
S03 - OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S - SENSORY ORGANS

Active Ingredient:CIPROFLOXACIN HYDROCHLORIDE

Active Ingredient UNII:4BA73M5E37

Drugbank ID:DB00537

PubChem Compound:2764

CTD ID:D002939

PharmGKB:PA449009

CAS Number:85721-33-1

Dosage Form(s):tablet

Route(s) Of Administrator:oral

Daily Dose:

1000.0 mg/day J01MA02

Chemical Structure:

SMILE Code:
OC(=O)C1=CN(C2CC2)C2=CC(N3CCNCC3)=C(F)C=C2C1=O

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