DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

LEVOFLOXACIN

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Less-DIR concern

Severity Score:1

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

WARNINGS AND PRECAUTIONS
Prolongation of the QT Interval
Some fluoroquinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including levofloxacin. Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions (6.3), Use in Specific Populations (8.5), and Patient Counseling Information (17.3)].
ADVERSE REACTIONS
Prolongation of the QT Interval [seeWarningsandPrecautions(5.10)]
Cardiac Disorders
isolated reports of torsade de pointes,electrocardiogram QT prolonged[seeWarnings and Precautions(5.10)]
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.
Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child's physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child's physician of any joint-related problems that occur during or following levofloxacin therapy [see Warnings and Precautions (5.11) and Use in Specific Populations (8.4)].
Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking fluoroquinolones. If patients need to be outdoors while using fluoroquinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.
MEDICATION GUIDE
Serious heart rhythm changes (QT prolongation and torsades 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. Levofloxacin 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 (hypokalemia)
who take certain medicines to control heart rhythm (antiarrhythmics)
USE IN SPECIFIC POPULATIONS
Elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using levofloxacin with concomitant drugs that can result in prolongation of the QT interval (e.g., Class IA or Class III antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions (5.10)].

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

166

42746

Other ADRs

31663

14085616

Odds Ratio = 1.728

Drug Property Information

ATC Code(s):

A02BD10 - levofloxacin

A02BD - Combinations for eradication of Helicobacter pylori
A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02 - DRUGS FOR ACID RELATED DISORDERS
A - ALIMENTARY TRACT AND METABOLISM

J01RA05 - levofloxacin

J01RA - Combinations of antibacterials
J01R - COMBINATIONS OF ANTIBACTERIALS
J01 - ANTIBACTERIALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

S01AE05 - levofloxacin

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

J01MA12 - levofloxacin

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

Active Ingredient:levofloxacin

Active Ingredient UNII:6GNT3Y5LMF

Drugbank ID:DB01137

PubChem Compound:149096

CAS Number:100986-85-4

Dosage Form(s):solution

Route(s) Of Administrator:oral

Daily Dose:

500.0 mg/day J01MA12

Chemical Structure:

SMILE Code:
C[C@H]1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=O)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

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[Seegobin Karan,Maharaj Satish,Baldeo Cherisse,Downes Julio Perez,Reddy Pramod]
Case Rep Infect Dis.2017;2017:8051096. doi: 10.1155/2017/8051096. Epub 2017 Oct 4. PMID: 29109879

2: ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations; Statin-Induced Muscle Rupture; Mefloquine-Induced Rhabdomyolysis; Methimazole-Induced Cholestatic Hepatitis; Decitabine-Induced Hand and Foot Syndrome.

[Mancano Michael A]
Hosp Pharm.2017 May;52(5):330-333. doi: 10.1177/0018578717715349. Epub 2017 May 1. PMID: 28804147

3: Levofloxacin-induced rhabdomyolysis: a case report.

[John Febin,Oluronbi Ruby,Pitchumoni C S]
J Med Case Rep.2016 Aug 24;10(1):235. doi: 10.1186/s13256-016-1004-6. PMID: 27557756

4: Acute rhabdomyolysis associated with coadministration of levofloxacin and simvastatin in a patient with normal renal function.

[Paparoupa Maria,Pietrzak Sebastian,Gillissen Adrian]
Case Rep Med.2014;2014:562929. doi: 10.1155/2014/562929. Epub 2014 Jul 22. PMID: 25140181

5: [Young male with fever and muscle pain after a visit to the dentist].

[de la Guerra Acebal Carla,Moreno Rodrigo Ana,Manterola Martija José María,Madariaga Ordeñana Idoia]
Enferm Infecc Microbiol Clin.2014 Nov;32(9):612-3. doi: 10.1016/j.eimc.2014.02.021. Epub 2014 May 9. PMID: 24813927

6: Quantitative evaluation of initial symptoms as predictors to detect adverse drug reactions using Bayes' theory: expansion and evaluation of drug-adverse drug reaction-initial symptom combinations using adverse event reporting system database.

[Kobayashi Daisuke,Hosaka Shigeru,Inoue Emiko,Ohshima Kimie,Kutsuma Nobuaki,Oshima Shinji,Okuno Yasushi]
Biol Pharm Bull.2013;36(12):1891-901. PMID: 24292049

7: Levofloxacin-induced rhabdomyolysis in a hemodialysis patient.

[Gupta Ankur,Guron Nita,Harris Michael,Bell Robert]
Hemodial Int.2012 Jan;16(1):101-3. doi: 10.1111/j.1542-4758.2011.00592.x. PMID: 22098607

8: Levofloxacin and rhabdomyolysis in a renal transplant patient.

[Korzets Asher,Gafter Uzi,Dicker Dror,Herman Michal,Ori Yaacov]
Nephrol Dial Transplant.2006 Nov;21(11):3304-5. Epub 2006 Sep 12. PMID: 16968728

9: Acute rhabdomyolysis associated with ofloxacin/levofloxacin therapy.

[Hsiao Shu-Hwa,Chang Chia-Ming,Tsao Chao-Jung,Lee Yu-Yun J,Hsu May-Ying,Wu Ta-Jen]
Ann Pharmacother.2005 Jan;39(1):146-9. Epub 2004 Nov 23. PMID: 15562138

10: A case of rhabdomyolysis with fatal outcome after a treatment with levofloxacin.

[Petitjeans Fabrice,Nadaud Julien,Perez Jean Paul,Debien Bruno,Olive Frederic,Villevieille Thierry,Pats Bruno]
Eur J Clin Pharmacol.2003 Dec;59(10):779-80. Epub 2003 Oct 24. PMID: 14576967

11: Toxic effects of quinolone antibacterial agents on the musculoskeletal system in juvenile rats.

[Kashida Y,Kato M]
Toxicol Pathol.1997 Nov-Dec;25(6):635-43. PMID: 9437810

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