VIGAMOX OPHTHALMIC SOLUTION 0.5%

4.1 Therapeutic indications

VIGAMOX solution is indicated for the treatment of bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible strains, as well as preoperative and postoperative prophylaxis.

Susceptible strains include:

Aerobic Gram‐positive microorganisms:

Corynebacterium species

Enterococcus faecalis*

Micrococcus luteus*

Staphylococcus aureus

Staphylococcus capitis*

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus lugdunensis*

Staphylococcus warneri*

Streptococcus pneumoniae

Streptococcus viridans group

Aerobic Gram‐negative microorganisms:

Acinetobacter lwoffii*

Burkholderia cepacia*

Haemophilus influenzae

Haemophilus parainfluenzae*

Klebsiella planticola*

Klebsiella pneumoniae*

Moraxella catarrhalis*

Proteus mirabilis*

Proteus vulgaris*

Pseudomonas aeruginosa*

Serratia liquefaciens*

Serratia marcescens*

Stenotrophomonas (Xanthomonas) maltophilia*

Other microorganisms:

Chlamydia trachomatis

Propionibacterium acnes

*Efficacy for this organism was studied in fewer than 10 infections.

Pediatric Use: The safety and effectiveness of VIGAMOX solution in bacterial conjunctivitis have been established in all ages including children and neonates.

There is no evidence that the ophthalmic administration of VIGAMOX solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.

4.3 Contraindications

Hypersensitivity to the active substance, to other quinolones or to any of the excipients.

4.2 Posology and method of administration

For blepharitis, dacryocystitis, hordeolum, conjunctivitis, tarsadenitis, keratitis (including corneal ulcer):

Usually instill one drop in the affected eye 3 times a day. Increase or decrease of frequency of instillation can be adjusted according to the symptoms.

For preoperative and postoperative prophylaxis: Usually, instill one drop in the affected eye 5 times per day for 2 days before operation, and 3 times a day up to 14 days after operation.

Patients should be instructed to leave at least 5 minutes between administrations if using VIGAMOX solution concurrently with other ophthalmic solutions.

Special populations

Renal impairment

Dose adjustment of moxifloxacin does not appear to be necessary in patients with renal dysfunction.

Hepatic impairment

Dose adjustment of moxifloxacin does not appear to be necessary in patients with mild to moderate hepatic impairment. The pharmacokinetics of moxifloxacin has not been studied in patients with severe hepatic insufficiency.

Pediatric patients (below 18 years)

Vigamox may be used in pediatric patients at the same dose as in adults.