Fluoroquinolone antibiotic Pregnancy: Contraindicated — ofloxacin must not be used during pregnancy (§4.3/§4.6). Breast-feeding should be discontinued during treatment because of potential arthropathy and other serious toxicity in the nursing infant.

Ofloxacin

Brand names: Tarivid, Exocin (eye)

Ofloxacin is a fluoroquinolone antibacterial used for certain urinary, respiratory and genital infections and as eye and ear drops.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 200 mg to 800 mg daily (dosage range for adults; the dose is determined by the type and severity of the infection)

Route: Oral

Frequency: Up to 400 mg may be given as a single daily dose, preferably in the morning; daily doses of more than 400 mg must be divided into two separate doses given at approximately equal intervals

Max: 800 mg daily total, given as 400 mg twice daily

Recommended doses by indication: gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae — a single 400 mg dose; uncomplicated cystitis — 200 mg to 400 mg daily; acute pyelonephritis and complicated urinary tract infections — 400 mg daily, increasing if necessary to 400 mg twice a day; community-acquired pneumonia and acute exacerbations of COPD including bronchitis — 400 mg daily, increasing if necessary to 400 mg twice a day; non-gonococcal urethritis and cervicitis — 400 mg daily. Increasing to the 800 mg daily maximum may be appropriate for pathogens with reduced or variable susceptibility, severe and/or complicated infections (e.g. respiratory or urinary tract), or inadequate response. Duration: treatment should not exceed 2 months. Hepatic impairment: in severe hepatic dysfunction (e.g. cirrhosis with ascites) the dose should not exceed 400 mg daily. Elderly: no dosage adjustment required other than that imposed by renal or hepatic function (see SPC §4.4 QT interval prolongation). Paediatric population: ofloxacin is contraindicated in children or growing adolescents (§4.3). Administration: swallow tablets whole with sufficient liquid before or during meal times; do not take within two hours of mineral antacids, sucralfate or metal ion preparations (aluminium, iron, magnesium or zinc) or didanosine chewable/buffered tablets. The openFDA record in this bundle is for ofloxacin OTIC solution 0.3% (a different route and indication set) and was not used for the systemic dose.

Dose adjustments

Renal

Following a normal initial dose, reduce maintenance dose in renal impairment: creatinine clearance 20-50 mL/min (plasma creatinine 1.5-5 mg/dL) — 100 mg to 200 mg ofloxacin per day; creatinine clearance below 20 mL/min (plasma creatinine 5 mg/dL) — 100 mg ofloxacin per day. Patients undergoing haemodialysis or peritoneal dialysis should be given 100 mg ofloxacin per day. Serum ofloxacin concentration should be monitored in severe renal impairment and dialysis patients.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance, to any other fluoroquinolone antibacterials, or to any of the excipients
History of epilepsy or an existing central nervous system disorder with a lowered seizure threshold
History of tendon disorders related to fluoroquinolone administration
Children or growing adolescents, and pregnant or breastfeeding women (risk of damage to growth-plate cartilage cannot be entirely excluded)
Latent or actual defects in glucose-6-phosphate dehydrogenase activity (risk of haemolytic reactions)

Side effects

Gastrointestinal: abdominal pain, diarrhoea, nausea, vomiting (uncommon)
Nervous system: dizziness, headache (uncommon); somnolence, paraesthesia, dysgeusia (rare); convulsion and peripheral neuropathy (very rare)
Psychiatric: agitation, sleep disorder, insomnia (uncommon); psychotic disorder, anxiety, confusional state, nightmares, depression (rare)
Skin: pruritus, rash (uncommon); urticaria, hyperhidrosis (rare); photosensitivity reaction, erythema multiforme, toxic epidermal necrolysis (very rare)
Hepatobiliary: increased hepatic enzymes and blood bilirubin (uncommon); severe liver injury including acute liver failure, sometimes fatal (very rare)
Prolonged, disabling and potentially irreversible reactions affecting musculoskeletal, nervous, psychiatric and sensory systems have been reported with fluoroquinolones (§4.4)

Interactions

Mineral antacids, sucralfate and metal ion preparations (aluminium, iron, magnesium, zinc) and didanosine chewable or buffered tablets reduce ofloxacin absorption — separate administration by at least two hours (eMC §4.2, cross-referencing §4.5)
Hypoglycaemic agents in diabetics — hypoglycaemia reported (eMC §4.8)
Other medicinal products that prolong the QT interval — ventricular arrhythmias and torsades de pointes reported predominantly in patients with risk factors for QT prolongation (eMC §4.8)

Clinical monograph

How it works

It inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA supercoiling and replication and producing a bactericidal effect.

Prescribing in practice

The MHRA advises systemic fluoroquinolones may cause disabling, potentially long-lasting or irreversible tendon, muscle, joint and nervous-system effects, and they should be reserved for when other antibiotics cannot be used.
Tendon rupture risk is higher in older patients, those on corticosteroids and those with renal impairment, and any tendon pain warrants stopping treatment.
It lowers the seizure threshold and can prolong the QT interval, so caution applies in epilepsy and with other QT-prolonging drugs.

Monitoring

Monitor for tendon, neurological and psychiatric symptoms during and after treatment, with cardiac assessment where QT risk factors exist.

Counselling the patient

Stop and seek advice if you get tendon pain or swelling, new numbness or tingling, or changes in mood.
Avoid excessive sun exposure as the skin may become more sensitive to light.

Evidence & guidelines

Reserve-use restrictions follow MHRA Drug Safety Updates, and antibacterial efficacy is established in the SPC.

Reference: MHRA Drug Safety Update; UK AMR; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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