DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

OFLOXACIN

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

PRECAUTIONS
Torsade de Pointes
Some quinolones, including ofloxacin, 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 quinolones, including ofloxacin. Ofloxacin 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.
[Other Information]
Patients should be advised:
that convulsions have been reported in patients taking quinolones, including ofloxacin, and to notify their physician before taking this drug if there is a history of this condition;
to inform their physician of any personal or family history of QTc 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. Patients should notify their physicians if they have any symptoms of prolongation of the QTc interval including prolonged heart palpitations or a loss of consciousness.
[Drug Interactions]
Elderly patients may be more sensitive to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ofloxacin 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 PRECAUTIONS, GENERAL, TORSADE DE POINTES).
MEDICATION GUIDE
Other serious side effects of ofloxacin tablets include:
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. Ofloxacin 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)

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42895

Other ADRs

2603

14114676

Odds Ratio = 2.15

Drug Property Information

ATC Code(s):

J01MA01 - ofloxacin

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

S02AA16 - ofloxacin

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

J01RA09 - ofloxacin

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

S01AE01 - ofloxacin

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

Active Ingredient:ofloxacin

Active Ingredient UNII:A4P49JAZ9H

Drugbank ID:DB01165

PubChem Compound:4583

CAS Number:82419-36-1

Dosage Form(s):tablet, coated

Route(s) Of Administrator:oral

Daily Dose:

400.0 mg/day J01MA01

Chemical Structure:

SMILE Code:
CC1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=O)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: 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

2: An unusual cause of acute renal failure in a kidney transplant recipient: salmonella enteritidis post-infectious glomerulonephritis.

[Pillet A,Guitard J,Mehrenberger M,Kamar N,Orfila C,Ribes D,Modesto A,Rostaing L]
Clin Nephrol.2007 May;67(5):321-4. PMID: 17542342

3: 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

4: 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

5: 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

6: Acute rhabdomyolysis during treatment with ofloxacin-a case report.

[Baril L,Maisonobe T,Jasson-Molinier M,Haroche J,Bricaire F,Caumes E]
Clin Infect Dis.1999 Dec;29(6):1598-9. PMID: 10585836

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