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AZITHROMYCIN MONOHYDRATE
DIR Classification
Classification:Most-DIQT concern
Severity Score:4.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- WARNINGS AND PRECAUTIONS
- QT Prolongation
- Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:
- patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
- patients on drugs known to prolong the QT interval
- patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Elderly patients may be more susceptible to drug-associated effects on the QT interval.
- ADVERSE REACTIONS
- Clinical Trials Experience
- Cardiovascular:Arrhythmias including ventricular tachycardia and hypotension. There have been reports of QT prolongation and torsades de pointes.
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- QTc interval prolongation was studied in a randomized, placebo-controlled parallel trial in 116 healthy subjects who received either chloroquine (1000 mg) alone or in combination with oral azithromycin (500 mg, 1000 mg, and 1500 mg once daily). Co-administration of azithromycin increased the QTc interval in a dose- and concentration- dependent manner. In comparison to chloroquine alone, the maximum mean (95% upper confidence bound) increases in QTcF were 5 (10) ms, 7 (12) ms and 9 (14) ms with the co-administration of 500 mg, 1000 mg and 1500 mg azithromycin, respectively.
- PATIENT PACKAGE INSERT
- Serious heart rhythm changes (QT prolongation and torsades de pointes).
- Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel faint and dizzy. Azithromycin 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 happening are higher in people:
- who are elderly
- with a family history of prolonged QT interval
- with low blood potassium
- who take certain medicines to control heart rhythm (antiarrhythmics)
- Worsening of myasthenia gravis (a problem that causes muscle weakness).
- Certain antibiotics like azithromycin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
423
23669
Other ADRs
48647
38332940
Odds Ratio = 14.083
Drug Property Information
ATC Code(s):
- J01FA10 - azithromycin monohydrate
- J01FA - Macrolides
- J01F - "MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS"
- J01 - ANTIBACTERIALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
- S01AA26 - azithromycin monohydrate
- S01AA - Antibiotics
- S01A - ANTIINFECTIVES
- S01 - OPHTHALMOLOGICALS
- S - SENSORY ORGANS
Active Ingredient:AZITHROMYCIN MONOHYDRATE
Active Ingredient UNII:JTE4MNN1MD
Drugbank ID:DB00207
PubChem Compound:447043
CTD ID:D017963
PharmGKB:PA448519
CAS Number:83905-01-5
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 300.0 mg/day J01FA10
Chemical Structure: 
SMILE Code:
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O
Reference
N/A
Disclaimer:
The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.
Any mention of commercial products is for clarification and not intended as endorsement.