- Approval Id
- 68dd399eda4f6978
- Drug Name
- VIGAMOX OPHTHALMIC SOLUTION 0.5%
- Product Name
- VIGAMOX OPHTHALMIC SOLUTION 0.5%
- Approval Number
- SIN12614P
- Approval Date
- 2004-11-17
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- NOVARTIS (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- **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.
- Route Of Administration
- OPHTHALMIC
- Indication Info
- **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.
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to the active substance, to other quinolones or to any of the excipients.
- Atc Code
- S01AX22
- Atc Item Name
- xs 01 ax 22
- Pharma Manufacturer Name
- NOVARTIS (SINGAPORE) PTE LTD
- Company Detail Path
- /organization/novartis-singapore-pte-ltd
