Ofloxacin

DRUG INFORMATION

  ADULT
    - The usual dose of ofloxacin tablets is 200 mg to 400 mg orally every 12 h as
      described in the following dosing chart.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29
    - Unit Dose Frequency Duration Daily Dose Acute Bacterial Exacerbation of Chronic
      Bronchitis 400 mg q12h 10 days 800 mg Comm.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29
    - A maximum dose of 400 mg of ofloxacin per day should therefore not be exceeded.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients and adolescents below the age of 18
      years have not been established. Ofloxacin causes arthropathy (arthrosis) and
      osteochondrosis in juvenile animals of several species (see WARNINGS ).
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'pediatric use', retrieved
      2026-08-29
    - The usual dose of ofloxacin tablets is 200 mg to 400 mg orally every 12 h as
      described in the following dosing chart. These recommendations apply to patients
      with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients
      with altered renal function (i.e., creatinine clearance ≤ 50 mL/min), see the
      Patients With Impaired Renal Function subsection. Infection DUE TO THE DESIGNATED
      PATHOGENS (see INDICATIONS AND USAGE ).
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29
    - Acquired Pneumonia 400 mg q12h 10 days 800 mg Uncomplicated Skin and Skin
      Structure Infections 400 mg q12h 10 days 800 mg Acute, Uncomplicated Urethral and
      Cervical Gonorrhea 400 mg single dose 1 day 400 mg Nongonococcal
      Cervicitis/Urethritis due to C. trachomatis 300 mg q12h 7 days 600 mg Mixed
      Infection of the Urethra and Cervix due to C. trachomatis and N.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - These recommendations apply to patients with normal renal function (i.e.,
      creatinine clearance > 50 mL/min).
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29
    - For patients with altered renal function (i.e., creatinine clearance ≤ 50 mL/min),
      see the Patients With Impaired Renal Function subsection.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29
    - Patients With Impaired Renal Function Dosage should be adjusted for patients with
      a creatinine clearance ≤ 50 mL/min.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for ofloxacin (OFLOXACIN),
      retrieved 2026-08-29

  PREGNANCY
    - Teratogenic Effects Pregnancy Category C Ofloxacin has not been shown to have any
      teratogenic effects at oral doses as high as 810 mg/kg/day (11 times the
      recommended maximum human dose based on mg/m 2 or 50 times based on mg/kg) and 160
      mg/kg/day (4 times the recommended maximum human dose based on mg/m 2 or 10 times
      based on mg/kg) when administered to pregnant rats and rabbits, respectively.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'pregnancy', retrieved
      2026-08-29
    - Additional studies in rats with oral doses up to 360 mg/kg/day (5 times the
      recommended maximum human dose based on mg/m 2 or 23 times based on mg/kg)
      demonstrated no adverse effect on late fetal development, labor, delivery,
      lactation, neonatal viability, or growth of the newborn.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'pregnancy', retrieved
      2026-08-29
    - Doses equivalent to 50 and 10 times the recommended maximum human dose of
      ofloxacin (based on mg/kg) were fetotoxic (i.e., decreased fetal body weight and
      increased fetal mortality) in rats and rabbits, respectively.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In lactating females, a single oral 200 mg dose of ofloxacin resulted in
      concentrations of ofloxacin in milk that were similar to those found in plasma.
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'nursing mothers',
      retrieved 2026-08-29
    - Because of the potential for serious adverse reactions from ofloxacin in nursing
      infants, a decision should be made whether to discontinue nursing or to
      discontinue the drug, taking into account the importance of the drug to the mother
      (see WARNINGS and ADVERSE REACTIONS ).
      Source: US FDA label for ofloxacin (OFLOXACIN), section 'nursing mothers',
      retrieved 2026-08-29