Gatifloxacin

DRUG INFORMATION

  ADULT
    - • Day 1: Instill one drop every two hours in the affected eye(s) while awake, up
      to 8 times. • Day 2 through Day 7: Instill one drop two to four times daily in the
      affected eye(s) while awake. Day 1: Instill one drop every two hours in the
      affected eye(s) while awake, up to 8 times on Day 1. Days 2 through 7: Instill one
      drop two to four times daily in the affected eye(s) while awake on Days 2 through
      7. ( 2 )
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of gatifloxacin ophthalmic solution in infants below
      one year of age have not been established. Gatifloxacin ophthalmic solution has
      been demonstrated in clinical trials to be safe and effective for the treatment of
      bacterial conjunctivitis in pediatric patients one year or older [see Clinical
      Studies (14) ].
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'pediatric use',
      retrieved 2026-08-29

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

  PREGNANCY
    - Risk Summary There are no available data on the use of gatifloxacin ophthalmic
      solution in pregnant women to inform a drug-associated risk.
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'pregnancy',
      retrieved 2026-08-29
    - Administration of oral gatifloxacin to pregnant rats and rabbits throughout
      organogenesis did not produce adverse development outcomes at clinically relevant
      doses.
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'pregnancy',
      retrieved 2026-08-29
    - Administration of gatifloxacin to rats during late gestation through lactation did
      not produce adverse maternal, fetal or neonatal effects at clinically relevant
      doses.
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Administration of gatifloxacin to rats during late gestation through lactation did
      not produce adverse maternal, fetal or neonatal effects at clinically relevant
      doses.
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'use in specific
      populations', retrieved 2026-08-29
    - In a perinatal/postnatal study in rats, oral administration of gatifloxacin during
      late gestation through lactation produced an increase in late gestation fetal loss
      and neonatal/perinatal mortality at 200 mg/kg/day (approximately 800-fold higher
      than the MRHOD on a mg/m 2 basis).
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'use in specific
      populations', retrieved 2026-08-29
    - Gatifloxacin was found in the breast milk of rats following oral administration of
      gatifloxacin during lactation.
      Source: US FDA label for gatifloxacin (Gatifloxacin), section 'use in specific
      populations', retrieved 2026-08-29