What is the recommended dosage of ofloxacin (fluoroquinolone antibiotic) for pediatric patients?

Ofloxacin Pediatric Dosing

For systemic ofloxacin in pediatric patients, administer 15-20 mg/kg/day for drug-resistant tuberculosis, or 7.5 mg/kg every 12 hours (maximum 400 mg/dose) for other infections; for ophthalmic use, instill 1-2 drops of 0.3% solution every 2-4 hours for 2 days, then four times daily for days 3-5; for otic use, administer 5 drops once daily for 7 days in children 6 months to <13 years. 1, 2, 3

Systemic (Oral/IV) Dosing

Drug-Resistant Tuberculosis

• Administer 15-20 mg/kg/day as the standard dosing range for multidrug-resistant tuberculosis (MDR-TB) treatment in children. 1, 2
• The dosing table from the American Thoracic Society provides weight-based guidance: children 5-6.9 kg receive 150 mg daily, 7-9.9 kg receive 200 mg daily, 10-13.9 kg receive 300 mg daily, 14-19.9 kg receive 400 mg daily, 20-29.9 kg receive 600 mg daily, 30-39.9 kg receive 800 mg daily, and ≥40 kg receive 1200 mg daily (maximum 1.0 g/day). 1
• This dosing can be given as a single daily dose or divided into two doses. 2

Important Caveat for TB Dosing

• Current pediatric dosing of 15-20 mg/kg results in significantly lower drug exposures compared to adults, with mean AUC0-24 of only 66.7 μg·h/ml versus the adult median of 103 μg·h/ml after standard 800 mg dosing. 4
• Pharmacokinetic studies demonstrate that children achieve approximately half the systemic exposure of adults, suggesting potential need for dosage modifications in certain clinical scenarios. 4

General Infections (Non-TB)

• Administer 7.5 mg/kg every 12 hours with a maximum of 400 mg per dose for general pediatric infections. 2
• This dosing applies to children ≥1 month to ≤17 years of age. 2

Community-Acquired Pneumonia

• For pneumonia caused by susceptible pathogens, ofloxacin may be used at 16-20 mg/kg/day in 2 doses for children 6 months to 5 years old, or 8-10 mg/kg/day once daily for children 5-16 years old (maximum 750 mg daily). 1
• Note that these are levofloxacin doses from the guidelines; ofloxacin is less commonly used for pneumonia and levofloxacin is preferred when a fluoroquinolone is indicated. 1

Ophthalmic (Eye Drop) Dosing

Bacterial Conjunctivitis

• For children ≥1 year old, instill 1-2 drops of ofloxacin 0.3% ophthalmic solution in affected eye(s) every 2-4 hours while awake for the first 2 days. 3
• Then reduce to 1-2 drops four times daily for days 3-5. 3
• Total treatment duration should be 5-7 days to ensure complete pathogen eradication. 3
• The intensive initial dosing (every 2-4 hours) for the first 1-2 days is critical for achieving adequate antimicrobial concentrations. 3

Administration Technique for Eye Drops

• Wash hands thoroughly before administration. 3
• Have the child lie down or tilt head back, gently pull down the lower eyelid to create a pocket. 3
• Apply gentle pressure to the inner corner of the eye for 1-2 minutes after instillation to minimize systemic absorption. 3
• For resistant infants and young children, administer drops while sleeping or use a helper to gently hold the child. 3

Otic (Ear Drop) Dosing

Otitis Externa

• For children 6 months to <13 years: instill 5 drops of ofloxacin 0.3% otic solution once daily in the affected ear(s) for 7 days. 5
• For adolescents/adults ≥13 years: instill 10 drops once daily for 7 days. 5
• This once-daily regimen achieves cure rates of 91-94% and is as effective as neomycin/polymyxin B/hydrocortisone given four times daily. 6, 5
• The once-daily dosing provides superior adherence (98% compliance) compared to more frequent regimens. 5

Safety Considerations and Warnings

Cartilage Development Concerns

• Fluoroquinolones, including ofloxacin, should be used with caution in young children due to potential effects on cartilage development. 2
• Use only when benefits clearly outweigh risks, particularly for systemic administration. 2

Topical Safety Profile

• Topical ophthalmic and otic ofloxacin have minimal systemic absorption and are considered safe in pediatric patients, with no concerns for cartilage toxicity. 3
• Ofloxacin otic lacks the ototoxicity risk associated with neomycin-containing preparations, making it particularly safe when tympanic membrane perforation status is uncertain. 7

Monitoring Requirements

• Regular monitoring for potential adverse effects is recommended with prolonged systemic use. 2
• No serious adverse events were observed in otic studies; minor events included pruritus (1%), increased earache (0.8%), and application-site reactions (0.6%). 5

Formulation Availability

• Ofloxacin oral suspension is not available in the United States, limiting options for young children who cannot swallow tablets. 2, 8
• Tablets must be crushed or split for weight-based dosing in smaller children when treating tuberculosis. 1