Ofloxacin – topical administration in the eye/ear

Generic name
Ofloxacin – topical administration in the eye/ear
Brand name
ATC Code
S01AE01
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Ofloxacin – topical administration in the eye/ear

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

After administration in the ear, serum concentrations are very low to undetectable [Okyama 1999].

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Eye infection, broad spectrum
  • Ocular
    • Eye salve
      • 1 month up to 18 years

        • As an addition to the treatment with eye drops during the day: Apply once a day before going to sleep.

      • 1 month up to 18 years
        [1] [5] [6] [9]

        • As an addition to the treatment with eye drops during the day: Apply once a day before going to sleep.
Chronic suppurative middle ear inflammation with perforated eardrum, middle ear inflammation with tubes, external ear inflammation
  • Auricular
    • Term neonate
      [14]
      • 5 drop(s)/dose 1-2x daily.

      • No studies have been carried out in children aged less than 6 months.

    • 1 month up to 12 years
      • 5 drop(s)/dose 1-2x daily.

      • No studies have been carried out in children aged less than 6 months.

    • 12 years up to 18 years
      • 10 drop(s)/dose 1-2x daily.
      • Duration of treatment:

        7-10 days

    • Eye salve
      • Term neonate
        • 5 drop(s)/dose 1-2x daily.

        • No studies have been carried out in children aged less than 6 months.

      • Term neonate
        • 5 drop(s)/dose 1-2x daily.

        • No studies have been carried out in children aged less than 6 months.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

When applied to the eye: burning sensation, photophobia, reduced vision
When applied to the ear: bitter taste, dizziness, dry mouth, itching, vertigo, ear pain, paraesthesia, tinnitus. No effects on hearing.
 

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In general, children´s eyes show a stronger response to irritations than the adults´ eyes. Irritations can affect the compliance of children. [SmPC Floxal® 3 mg/ml eye drops (GER)]

The use of contact lenses is not recommended in patients being treated for an eye infection [SPC ofloxacin].

Contact lens wearers have an increased risk of infectious keratitis, which can lead to serious complications such as corneal ulceration and permanent vision loss within 24 hours. Ask every patient with a corneal abnormality explicitly about contact lens use. According to the dutch NHG Standard Red Eye and Eye Trauma, traumatic corneal erosion in contact lens wearers—both adults and children—is treated with ofloxacin eye drops 0.3% 6–8 times a day or eye ointment 6 times a day until the symptoms and erosion have disappeared. Please note that the optimal frequency of application is not substantiated in the literature; it is based on expert opinion (ophthalmologists, microbiologists and pharmacists) and has not been studied in children. Consult an ophthalmologist for children who wear contact lenses [NHG Red Eye and Eye Trauma].

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIINFECTIVES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
S01AA26
S01AA01
S01AA13
S01AA11
S01AA24
S01AA20
S01AA12
Antivirals
S01AD03
ANTIBIOTICS
S01AA26
S01AA01
S01AA13
S01AA11
S01AA24
S01AA20
S01AA12
ANTIVIRALS
S01AD03
Fluoroquinolones
S01AE07

References

  1. Constantinou M, et al, Clinical efficacy of moxifloxacin in the treatment of bacterial keratitis: a randomized clinical trial, Ophthalmology, 2007, Sep;114(9), 1622-9
  2. Schwartz RH., Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients , Curr Med Res Opin, 2006, Sep;22(9), 1725-36
  3. Torum B, et al, Efficacy of ofloxacin otic solution once daily for 7 days in the treatment of otitis externa: a multicenter, open-label, phase III trial., Clin Ther, 2004, Jul;26(7), 1046-54
  4. Roland PS, et al, Topical ciprofloxacin/dexamethasone otic suspension is superior to ofloxacin otic solution in the treatment of children with acute otitis media with otorrhea through tympanostomy tubes, Pediatrics, 2004, Jan;113(1 Pt 1), e40-6
  5. Lichtenstein SJ, et al, Efficacy and safety of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in pediatric patients, J AAPOS, 2003, Oct;7(5), 317-24
  6. Schwab IR, et al, A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis, Ophthalmology, 2003, Mar;110(3), 457-65
  7. Goldblatt EL., Efficacy of ofloxacin and other otic preparations for acute otitis media in patients with tympanostomy tubes, Pediatr Infect Dis J., 2001, Jan;20(1), 116-9; discussion 120-2
  8. Bluestone CD, Efficacy of ofloxacin and other ototopical preparations for chronic suppurative otitis media in children, Pediatr Infect Dis J, 2001, Jan;20(1), 111-5; discussion 120-2
  9. Tabbara KF, et al, Treatment of acute bacterial conjunctivitis with topical lomefloxacin 0.3% compared to topical ofloxacin 0.3%, Eur J Ophthalmol, 1999, Oct-Dec;9(4), 269-75
  10. Dohar JE, et al, Topical ofloxacin treatment of otorrhea in children with tympanostomy tubes, Arch Otolaryngol Head Neck Surg, 1999, May;125(5), 537-45
  11. Ohyama M, et al, Ofloxacin otic solution in patients with otitis media: an analysis of drug concentrations, Arch Otolaryngol Head Neck Surg, 1999, Mar;125(3), 337-40
  12. Goldblatt EL, et al, Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes, Int J Pediatr Otorhinolaryngol, 1998, Nov 15;46(1-2), 91-101
  13. Agro AS, et al, Clinical trial of ototopical ofloxacin for treatment of chronic suppurative otitis media, Clin Ther., 1998, Jul-Aug;20(4), 744-59
  14. Kaga K, et al, A preliminary report: clinical effects of otic solution of ofloxacin in infantile myringitis and chronic otitis media, Int J Pediatr Otorhinolaryngol., 1998, Jan;42(3), 199-205
  15. Jones RN, et al, Ofloxacin otic solution for treatment of otitis externa in children and adults, Arch Otolaryngol Head Neck Surg, 1997, Nov;123(11), 1193-200
  16. NHG Richtlijnen, Rood oog en oogtrauma, 12-2017, https://richtlijnen.nhg.org/standaarden/rood-oog-en-oogtrauma
  17. URSAPHARM Benelux B.V., SPC Ofloxacine (RVG 110894 ) 06-2020
  18. Schwartz RH., Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension four times a day: a multicenter, randomized, evaluator-blinded trial to compare the efficacy, safety, and pain relief in pediatric patients, Curr Med Res Opin, 2006, Sep;22(9), 1725-36

Changes

Therapeutic Drug Monitoring


Overdose