Each film coated tablet contains 200 mg or 400 mg ofloxacin USP.
Ofloxacin is an antibacterial of the group of quinolones. It is active against a wide range of micro-organisms including Haemophilus influenzae, Escherichia coli, Kiebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Chlamydia trachometis and Neisseria gonorrhoeae. It also inhibits the growth of Mycobacterium spp. It is used in a wide range of infections including lower respiratory infection and urinary tract infection. Ofloxacin is also used in sexually transmitted diseases such as gonorrhoea and pelvic inflammatory disease (PID) due to chlamydia, but is not effective against syphilis.
It is also part of a regimen to treat multiresistant tuberculosis and has been proven to be effective in lepra.
Swallow the tablets with liquid. Dosage and duration of treatment is dependent on severity and sensitivity of causative organism. Treatment should not exceed 2 months duration.
Lower respiratory tract infections: 400 mg daily increasing, if necessary, to 400 mg twice daily.
Lower urinary tract infection: 200 – 400 mg daily.
Upper urinary tract infection: 200 – 400 mg daily increasing, if necessary, to 400 mg twice daily.
Gonorrhoea: 400 mg as a single dose.
Pelvic inflammatory disease: 400 mg twice daily for 14 days.
Non-gonococcal urethritis: 400 mg daily in single or divided doses.
Skin and soft tissue infections: 400 mg twice daily.
Multidrug-resistant tuberculosis: 600 – 800 mg daily in single or divided doses, with other anti tuberculosis drugs according to the treatment protocol.
Single-lession paucibacillary leprosy: 400 mg as a single dose in combination with minocycilne and rifampicin.
Impaired renal function
Creatinine clearance 20-50 ml/minute: Following a normal initial dose, half dosage.
Creatinine clearance < 20 ml/minute and patients undergoing dialysis: Following a normal initial doses, 100 mg every 24 hours.
Pregnancy and breast-feeding
Avoid use of ofloxacin during pregnancy. If the mother is breastfeeding, use alternative drug if possible.
Contraindications and warnings
Ofloxacin should not be used in patients who are hypersensitive to quinolone antibacterials, with a history of epilepsy or tendinitis, CNS disorders or conditions that predispose to seizures. Ofloxacin should be used with caution in G6PD deficiency or in myasthenia gravis (risk of exacerbation) Reduce dose in severe hepatic impairment and renal impairment. Avoid exposure to excessive sunlight (discontinue if photosensitivity reactions occur) Ofloxacin is not recommended for children and growing adolescents.
Antacids (aluminium hydroxide; magnesium hydroxide), sucralfate and ferrous salts may reduce the absorption of ofloxacin. Ofloxacin should be given at least 2 hours before the intake of such products. Ofloxacin enhances the anticoagulant effect of coumarins. Concomitant use of cyclosporin may increase the risk of nephrotoxicity. Ibuprofen and/or theophylline may increase possible risk of convulsions. Ofloxacin may impair the ability to perform skilled tasks, for example operating machinery or driving. Avoid concomitant use of ofloxacin and artemether and lumefantrine.
Convulsions in patients with or without history of convulsions, nausea, vomiting abdominal pain, diarrhoea, headache, dizziness, visual disturbance, pruritus, fever, sleep disorders and CNS disturbances. Rarely Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis, anorexia, increase in liver enzymes, bilirubin or
blood urea, depression, confusion and hallucinations, tremor, disturbances in taste and smell, extrapyramidal symptoms, tachycardia, transient hypotension. Very rarely cholestatic jaundice, hepatitis, pseudomembranous colitis, blood disorders, changes in blood-sugar levels, joint and muscle pains. Ther drug should be discontinued if hypersensitivity (including severe rash), psychiatric or neurological reactions occur.
Symptoms: Confusion, dizziness, impairment of consciousness and seizures as well as gastro-intestinal reactions such as nausea and mucosal erosions.
Treatment: Gastric lavage and symptomatic treatment should be implemented. No specific antidote exists.
Store in a dry place below 25oC.
Ofloxacin 200 mg – NAFDAC Reg. No. A4-6369
Ofloxacin 400 mg – NAFDAC Reg. No. A4-6370
Macleods Pharmaceutical Ltd.,
Damian – India.
1030 AB Amsterdam,