Adult: As 0.3% ophthalmic solution: Instil 1-2 drops into the affected eye(s) 2-4 hourly on days 1 and 2, then reduce frequency to 4 times daily on days 3-7. Max treatment duration: 10 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines). Child: ≥1 year Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Ophthalmic Bacterial corneal ulcer
Adult: As 0.3% ophthalmic solution: On days 1 and 2, instil 1-2 drops into the affected eye(s) every 30 minutes while awake and at approx 4 and 6 hours after retiring. On days 3 to 7 or 9, instil 1-2 drops hourly while awake, then instil 1-2 drops 4 times daily until completely healed. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines). Child: ≥1 year Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Complicated skin and soft tissue infections
Adult: 400 mg bid for 7-10 days. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Prostatitis
Adult: 200 mg bid for 14 or 28 days. Alternatively, 300 mg bid for 6 weeks. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Pelvic inflammatory disease
Adult: 400 mg bid for 10-14 days. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Nongonococcal cervicitis due to Chlamydia trachomatis, Nongonococcal urethritis due to Chlamydia trachomatis
Adult: 400 mg daily as a single dose or in divided doses. Alternatively, 300 mg 12 hourly. Treatment duration: 7 days. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Lower respiratory tract infections
Adult: 400 mg daily, may increase to 400 mg bid for 7-10 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Uncomplicated cystitis
Adult: 200 mg bid for 3-7 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Uncomplicated skin and skin structure infections
Adult: 400 mg 12 hourly for 10 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Adult: 200 mg bid, may be increased to 400 mg bid for 7-10 days. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Oral Uncomplicated gonorrhoea
Adult: 400 mg as a single dose. Treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Otic/Aural Acute otitis media
Child: 1-12 years In patients with tympanostomy tubes: As 0.3% otic solution: Instil 5 drops into the canal of the affected ear(s) bid for 10 days.
Otic/Aural Otitis externa
Adult: As 0.3% otic solution: Instil 10 drops into the canal of the affected ear(s) once daily for 7 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines). Child: 6 months to 13 years As 0.3% otic solution: Instil 5 drops into the canal of the affected ear(s) once daily for 7 days; >13 years Same as adult dose.
Otic/Aural Otitis media
Adult: Chronic suppurative cases with perforated tympanic membranes: As 0.3% otic solution: Instil 10 drops into the canal of the affected ear(s) bid for 14 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to local or specific product guidelines). Child: ≥12 years Same as adult dose.
What are the brands available for Ofloxacin in Hong Kong?
Oral: Uncomplicated cystitis; Complicated urinary tract infections; Pyelonephritis; Prostatitis; Uncomplicated skin and skin structure infections; Lower respiratory tract infections; Complicated skin and soft tissue infections; Pelvic inflammatory disease; Nongonococcal urethritis or cervicitis due to Chlamydia trachomatis:
Patient on haemodialysis or peritoneal dialysis: Reduce dose to 100 mg 24 hourly after the usual initial dose.
CrCl (mL/min)
Dosage
<20
Reduce dose to 100 mg 24 hourly or half of the normal recommended dose 24 hourly after the usual initial dose.
20-50
Reduce dose to 100-200 mg 24 hourly or the normal recommended dose 24 hourly after the usual initial dose.
Hepatic Impairment
Oral: Uncomplicated cystitis; Complicated urinary tract infections; Pyelonephritis; Prostatitis; Uncomplicated skin and skin structure infections; Lower respiratory tract infections; Complicated skin and soft tissue infections; Pelvic inflammatory disease; Nongonococcal urethritis or cervicitis due to Chlamydia trachomatis:
Severe (e.g. cirrhosis with or without ascites): Dose reduction may be required. Max: 400 mg daily.
Administration
Ofloxacin May be taken with or without food. Do not take polyvalent cation-containing products w/in 2 hr of ofloxacin.
Contraindications
Hypersensitivity to ofloxacin or any quinolone antibiotics. Oral: History of tendon disorders associated with quinolone use, history of epilepsy or with a lowered seizure threshold.
Special Precautions
Patient with known risk factors for QT interval prolongation (e.g. congenital long QT syndrome, uncorrected hypokalaemia or hypomagnesaemia, heart failure, MI, bradycardia; concurrently receiving class IA or III antiarrhythmics, antipsychotic agents, TCAs or macrolides); family history of aneurysm disease, congenital heart valve disease, pre-existing aortic aneurysm and/or dissection or other risk factors or conditions predisposing to aortic aneurysm and dissection (e.g. Takayasu arteritis, giant cell arteritis, Sjogren's syndrome, known atherosclerosis), heart valve disease or conditions predisposing to heart valve regurgitation/incompetence (e.g. infective endocarditis), risk factors for both aortic aneurysm and heart valve regurgitation/incompetence (e.g. Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Behcet's disease, rheumatoid arthritis, hypertension); psychiatric disease or history of psychotic disorder, history of or risk factors for depression; latent or diagnosed G6PD deficiency, diabetes; corneal epithelial defects or ulcers (ophthalmic). Solid organ (e.g. heart, kidney, lung) transplant recipients. Avoid use in patients with known history of myasthenia gravis. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Tendon rupture or tendinitis, arthralgia, myalgia, peripheral neuropathy, CNS effects (e.g. seizures, tremors, lightheadedness, increased intracranial pressure), blood glucose regulation disturbances (including hyperglycaemia), psychiatric reactions (e.g. hallucinations, anxiety, depression, insomnia, confusion, agitation, toxic psychosis), photosensitivity or phototoxicity; fungal or bacterial superinfection (prolonged use); increased risk of heart valve regurgitation. Rarely, QT interval prolongation, torsades de pointes; haemolytic reactions (particularly in G6PD deficient patients). Cardiac disorders: Chest pain. Ear and labyrinth disorders: Vertigo; earache, application site reactions (otic). Eye disorders: Blurred vision, transient ocular burning or discomfort, increased lacrimation, photophobia, foreign body sensation in eyes, chemical conjunctivitis or keratitis, ocular or periocular oedema, eye dryness, pain, stinging, pruritus or redness (ophthalmic). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dysgeusia, abdominal pain or cramps, flatulence, gastrointestinal distress, dry mouth. General disorders and administration site conditions: Fever, fatigue; facial oedema (ophthalmic). Metabolism and nutrition disorders: Decreased appetite. Nervous system disorders: Headache, dizziness, somnolence. Psychiatric disorders: Sleep disorder. Reproductive system and breast disorders: Vaginitis, genital pruritus. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, cough. Skin and subcutaneous tissue disorders: Pruritus, rash. Potentially Fatal: Hypersensitivity reactions (e.g. anaphylaxis, anaphylactic shock), severe bullous skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome); Clostridioides difficile-associated diarrhoea or pseudomembranous colitis; fulminant hepatitis potentially leading to hepatic failure; aortic aneurysm and dissection (sometimes complicated by rupture), exacerbation of myasthenia gravis; severe hypoglycaemia.
PO: C (Caution especially in 1st trimester); Ophth/Otic: C
Patient Counseling Information
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 (e.g. sunlamps, solarium) during treatment and for 48 hours after discontinuation of treatment; use protective measures (e.g. sunscreen, loose-fitting clothes) when going outdoors. Ophthalmic: Wearing of contact lenses during treatment of an eye infection is not recommended.
Monitoring Parameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor CBC, hepatic and renal function periodically (prolonged therapy); blood glucose levels in diabetic patients. Assess for signs and symptoms of hypersensitivity reactions, tendinitis, severe or bloody diarrhoea, neuropathy, altered mental status, and hepatic disease. In patients with gonorrhoea, conduct a test for syphilis at the time of diagnosis and 3 months after treatment.
Overdosage
Symptoms: Dizziness, confusion, impaired consciousness, increased QT interval, convulsive seizures, nausea, vomiting, mucosal erosions. Management: Symptomatic and supportive treatment. May employ gastric lavage or administer adsorbents and Na sulfate during the 1st 30 minutes to remove any unabsorbed drug. Antacids may be given to protect the gastric mucosa. Elimination may be increased by forced diuresis. Monitor ECG.
Drug Interactions
Concomitant use with corticosteroids may increase the risk of tendon rupture or tendinitis. Increased risk of QT interval prolongation with class IA or class III antiarrhythmic agents, antipsychotics, TCAs, and macrolides. May reduce absorption with Mg-, Ca- or Al-containing antacids, Zn or Fe preparations, sucralfate, and didanosine chewable or buffered tab. May enhance the effects of vitamin K antagonists (e.g. warfarin). May decrease clearance and increase serum levels with drugs that undergo renal tubular secretion (e.g. probenecid, cimetidine). Concurrent use with agents that decrease seizure threshold (e.g. theophylline, certain NSAIDs) may cause a pronounced lowering of the cerebral seizure threshold. Concomitant administration with oral hypoglycaemic agents (e.g. glibenclamide) or insulin may cause alterations in blood glucose levels resulting in hypoglycaemia.
Lab Interference
May cause false-positive results in the determination of opiates or porphyrin levels in urine.
Action
Description: Mechanism of Action: Ofloxacin is a broad-spectrum fluoroquinolone antibiotic with bactericidal action. It inhibits DNA gyrase and topoisomerase IV enzymes required for DNA replication, transcription, repair, transposition and recombination, which leads to bacterial cell death. Pharmacokinetics: Absorption: Rapidly and well absorbed from the gastrointestinal tract. Bioavailability: 85-100% (oral). Time to peak plasma concentration: 0.5-2 hours. Distribution: Widely distributed into body tissues and fluids, including CSF, sputum, blister fluid, skin, lung, cervix, ovary, and prostatic tissue. Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 120 L. Plasma protein binding: 20-32%. Metabolism: Limited metabolism into desmethyl and N-oxide metabolites. Excretion: Via urine (65-80% as unchanged drug, <5% as metabolites); faeces (4-8%). Elimination half-life: Biphasic: Approx 4-5 hours and 20-25 hours.
Chemical Structure
Ofloxacin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4583, Ofloxacin. https://pubchem.ncbi.nlm.nih.gov/compound/Ofloxacin. Accessed Feb. 25, 2025.
Storage
Tab/Otic solution: Store between 20-25°C. Protect from light. Protect the tab from moisture. Ophthalmic solution: Store between 15-25°C. Protect from light. Storage recommendations may vary between individual products (refer to specific product guidelines).
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. J01MA01 - ofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
References
Anon. Ofloxacin (Systemic). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/07/2024.Anon. Ofloxacin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 24/01/2025.Brayfield A, Cadart C (eds). Ofloxacin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/07/2024.Effexin Otic Solution (Pharmaforte [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/01/2025.Exocin 3 mg/mL Eye Drops, Solution (AbbVie Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/07/2024.Hovid Ofloxacin Eye Drops 0.3% w/v (Hovid Berhad). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/07/2024.Joint Formulary Committee. Ofloxacin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/07/2024.Ocuflox Ophthalmic Solution/Drops (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/07/2024.Ofcin Film Coated Tablet 200 mg and 400 mg (Y.S.P. Industries [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/01/2025.Oflomac Tablets 200 mg (Zulat Pharmacy Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/01/2025.Ofloxacin (Ophthalmic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 24/01/2025.Ofloxacin (Otic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 24/01/2025.Ofloxacin (Systemic). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 24/01/2025.Ofloxacin 200 mg Tablets (Bristol Laboratories Ltd). MHRA. https://products.mhra.gov.uk. Accessed 24/01/2025.Ofloxacin Otic Solution/Drops (Caplin Steriles Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 24/01/2025.Ofloxacin Tablet, Coated (Nivagen Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/07/2024.Tarivid Ophthalmic Solution (Santen Pharma Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 24/01/2025.
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