DIQTA 1.0: Drug-Induced QT Prolongation Atlas

CHLOROQUINE PHOSPHATE

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
Cardiac Effects
Cases of cardiomyopathy resulting in cardiac failure, in some cases with fatal outcome, have been reported in patients treated during long term therapy at high doses with chloroquine (see ADVERSE REACTIONS and OVERDOSAGE). Monitor for signs and symptoms of cardiomyopathy and discontinue chloroquine if cardiomyopathy develops. Chronic toxicity should be considered when conduction disorders (bundle branch block / atrio-ventricular heart block) are diagnosed. If cardiotoxicity is suspected, prompt discontinuation of chloroquine may prevent life-threatening complications. QT interval prolongation, torsades de pointes, and ventricular arrhythmias have been reported. The risk is greater if chloroquine is administered at high doses. Fatal cases have been reported. Chloroquine should be used with caution in patients with cardiac disease, a history of ventricular arrhythmias, uncorrected hypokalemia and/or hypomagnesemia, or bradycardia (˂50 bpm), and during concomitant administration with QT interval prolonging agents due to potential for QT interval prolongation (see WARNINGS, PRECAUTIONS, DRUG INTERACTIONS, ADVERSE REACTIONS and OVERDOSAGE).
PRECAUTIONS
Drug Interactions
Arrhythmogenic drugs: There may be an increased risk of inducing ventricular arrhythmias if chloroquine is used concomitantly with other arrhythmogenic drugs, such as amiodarone or moxifloxacin.
OVERDOSAGE
Signs and Symptoms: Chloroquine is very rapidly and completely absorbed after ingestion. Toxic doses of chloroquine can be fatal. As little as 1 g may be fatal in children. Toxic symptoms can occur within minutes. The symptoms of overdosage may include nausea, vomiting, headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required, as these effects may appear shortly after the overdose. Cases of extrapyramidal disorders have also been reported in the context of chloroquine overdose (see WARNINGS and ADVERSE REACTIONS).
ADVERSE REACTIONS
Cardiac arrhythmias, conduction disorders such as bundle branch block / atrio-ventricular block, QT interval prolongation, torsade de pointes, ventricular tachycardia and ventricular fibrillation have been reported with therapeutic doses of chloroquine as well as with overdose. The risk is greater if chloroquine is administered at high doses. Fatal cases have been reported (see WARNINGS, CARDIAC EFFECTS and OVERDOSAGE).

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24063

Other ADRs

2591

38378996

Odds Ratio = 17.852

Drug Property Information

ATC Code(s):

P01BA01 - chloroquine phosphate

P01BA - Aminoquinolines
P01B - ANTIMALARIALS
P01 - ANTIPROTOZOALS
P - "ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS"

Active Ingredient:CHLOROQUINE PHOSPHATE

Active Ingredient UNII:6E17K3343P

Drugbank ID:DB00608

PubChem Compound:2719

CTD ID:D002738

PharmGKB:PA448948

CAS Number:54-05-7

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

500.0 mg/day P01BA01

Chemical Structure:

SMILE Code:
CCN(CC)CCCC(C)NC1=CC=NC2=CC(Cl)=CC=C12

Reference

1: {'i': 'Torsade de Pointes', '#text': 'Lethal Arrhythmia () in COVID-19: An Event Synergistically Induced by Viral Associated Cardiac Injury, Hyperinflammatory Response, and Treatment Drug?'}

[Yasmin Kusumawardhani Nuraini,Huang Ian,Martanto Erwan,Sihite Teddy Arnold,Nugraha Eka Surya,Prodjosoewojo Susantina,Hamijoyo Laniyati,Hartantri Yovita]
Clin Med Insights Case Rep,2020 Dec 14;13:1179547620972397. PMID: 33402858

2: Hydroxychloroquine and COVID-19 - A narrative review.

[Bajpai Jyoti,Pradhan Akshyaya,Singh Abhishek,Kant Surya]
Indian J Tuberc,2020 Dec;67(4S):S147-S154. PMID: 33308661

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