Generic Medicine Info
May be taken with or without food. Avoid antacids or supplements containing Fe or Zn w/in 2 hr before or after ofloxacin. Ensure adequate hydration.
Hypersensitivity to ofloxacin or to other quinolone antibacterials. History of tendon disorders associated with quinolone use, epilepsy or lowered seizure threshold.
Special Precautions
Patient with known/suspected CNS disorders (e.g. epilepsy, severe cerebral arteriosclerosis) or risk factors that may predispose to seizures or lower the seizure threshold; myasthenia gravis, rheumatoid arthritis, latent or diagnosed G6PD deficiency, risk factors for QT interval prolongation (e.g. congenital long QT syndrome, uncorrected hypokalaemia or hypomagnesaemia, heart failure, MI, bradycardia), history of aneurysm disease, pre-existing aortic aneurysm/dissection or its predisposing conditions (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu/giant cell arteritis, Behcet's disease); psychiatric disease, history of psychotic disorder or risk factor for depression; diabetes. Organ transplant recipients. Not indicated for the treatment of syphilis as it may mask symptoms (oral). Renal and hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause drowsiness, dizziness and visual disturbances; if affected, do not drive or operate machinery. Avoid excessive exposure to sunlight or artificial UV light. Do not wear contact lenses during treatment of ophthalmic infections. Monitoring Parameters Monitor CBC, hepatic and renal function periodically (prolonged therapy). Perform culture and sensitivity tests and consult local recommendations before treatment initiation due to antibiotic resistance risks; test for syphilis at the time of gonorrheal diagnosis and 3 months later. Assess for signs and symptoms of glucose disturbances, CNS effects, and tendon problems. Monitor ofloxacin serum concentration for patient with severe renal impairment and on dialysis (IV).
Adverse Reactions
Significant: Tendon rupture or tendinitis, aortic aneurysm ruptures or dissection, CNS effects (e.g. seizures, tremors, dizziness, lightheadedness, increased intracranial pressure), hyperglycaemia, psychiatric reactions (e.g. hallucinations, toxic psychosis), phototoxicity. Rarely, peripheral neuropathy, QT interval prolongation, torsades de pointes, haemolytic reactions (G6PD deficient patients). Cardiac disorders: Chest pain. Ear and labyrinth disorders: Vertigo. Otic: Earache, application site reactions. Eye disorders: Visual disturbance. Ophthalmic: Blurred vision, ocular burning or discomfort (transient), lacrimation, photophobia, foreign body sensation in eyes, chemical conjunctivitis, keratitis; eye discomfort, dryness, pain, pruritus or redness. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dysgeusia, abdominal pain or cramps, flatulence, gastrointestinal distress, dry mouth. General disorders and administration site conditions: Fever, infusion site reaction (IV). Infections and infestations: Pathogen resistance, fungal infection. Metabolism and nutrition disorders: Decreased appetite. Nervous system disorders: Headache, dizziness, drowsiness. Psychiatric disorders: Insomnia, agitation, sleep disorder, nervousness, somnolence. Reproductive system and breast disorders: Vaginitis, genital pruritus. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, cough. Skin and subcutaneous tissue disorders: Pruritus, rash. Vascular disorders: Phlebitis (IV).
Potentially Fatal: Fungal or bacterial superinfection including C. difficile-associated diarrhoea (CDAD) and pseudomembranous colitis (prolonged use); liver failure, myasthenia gravis exacerbation, severe hypoglycaemia. Rarely, severe bullous skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome), hypersensitivity reactions (e.g. anaphylaxis, anaphylactic shock).
ROUTE(S) : Ophth / Otic: C
ROUTE(S) : PO: C Caution esp in 1st trimester.
Drug Interactions
Increased risk of tendon rupture or inflammation with concomitant use of corticosteroids. Increased risk of QT interval prolongation with Class IA and III anti-arrhythmics, TCAs, macrolides, antipsychotics. May increase the risk of bleeding when given with vitamin K antagonists (e.g. warfarin). Reduced absorption with Mg-, Ca- or Al-containing antacids, Zn or Fe preparations, sucralfate and didanosine chewable or buffered tab. Decreased clearance with drugs that affect the renal tubular secretion (e.g. probenecid, furosemide, cimetidine, methotrexate). May slightly increase plasma levels of glibenclamide. Theophylline and NSAIDs may cause pronounced lowering of cerebral seizure threshold.
CIMS Class
Ear Anti-Infectives & Antiseptics / Eye Anti-Infectives & Antiseptics / Quinolones
ATC Classification
J01MA01 - ofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
S01AE01 - ofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
S02AA16 - ofloxacin ; Belongs to the class of antiinfectives used in the treatment of ear infections.
Disclaimer: This information is independently developed by CIMS based on ofloxacin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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