Brand Name, Dosage Format and Strength
200 mg Tablet
Anti-infectives (Systemic), Eye Anti-Infectives
Aminoglycoside, Cephalosporin, Chloramphenicol, Lincosamide, Macrolide, Penicillin, Penicillin + Beta lactamase Inhibitor , Penicillinase-resistant isoxazolylpenicillin, Penicillin; Beta-lactam + Beta-lactamase Inhibitor, Quinolone, Sulfonamide + Folate Inhibitor, Tetracycline, Triazole Antibiotic, Immunostimulant, Neuraminidase Inhibitor, Quinolone
STATEMENT ON USAGE FOR HIGH RISK GROUPS
Pregnancy: (Pregnancy Category C) Ofloxacin crosses the placenta and is distributed into cord blood and amniotic fluid. There have been no adequate and well-controlled studies using ofloxacin in pregnant women. Since ofloxacin, like most other fluoroquinolones, can cause arthropathy in immature animals, ofloxacin should not be used in pregnant women unless the benefits justify the potential risks.
Lactation: Ofloxacin is distributed in breast milk. It is therefore advised that breastfeeding women refrain from using the drug unless there are no other safe and effective antibiotic that can be used as an alternative.
Children: Safety and efficacy in children < 18 yrs old have not been established.
In immature rats, oral ofloxacin dosages 5 to 16 times the usual human dose increased the incidence and severity of osteochondrosis and lesions were still present and had not regressed even after 13 wks of drug discontinuation. Studies in various species of immature animals also showed that ofloxacin and other fluoroquinolones can cause erosion of the cartilage in weight-bearing joints and other signs of arthropathies.
Elderly: Precaution should be taken when using ofloxacin with concomitant drugs which can result in prolongation of the QT interval or with risk factors for torsades de pointes.
Patients over 65 yrs old being treated with fluoroquinolones such as ofloxacin are at increased risk for developing severe tendon disorders including tendon rupture. This risk is further increased with concomitant steroid therapy.
Renal and Hepatic Impairment: Ofloxacin’s serum concentrations are higher and the drug’s t1/2 may be prolonged in patients with renal impairment. In patients with end-stage renal disease, the drug’s t1/2 may range from 25 to 48 hrs. Although there is insufficient data regarding the drug’s PK in patients with hepatic impairment, it is expected that the drug’s elimination may be reduced. Ofloxacin should, therefore, be used with caution in patients with impaired renal or hepatic function. Careful patient monitoring and appropriate laboratory studies should be performed prior to and during therapy with ofloxacin.