Composition
Vofox Eye Drops: Each ml contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin 5 mg.
Preservative: Benzalkonium Chloride Solution BP 0.033%
Pharmacology
Vofox (Levofloxacin) is a 3rd generation fluoroquinolone antimicrobial that shows antibacterial activity by inhibiting bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes required for DNA replication, transcription, repairing and recombination. Vofox (Levofloxacin) has a wide spectrum of activities against different Gram-positive bacteria e.g., Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococci Group C/F, Streptococci Group G, streptococci Viridans Group and Gram-negative bacteria e.g., Pseudomonas aeruginosa, Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens.
Indication
Vofox (Levofloxacin) Sterile Eye Drop is indicated for the treatment of bacterial conjunctivitis and other superficial infections caused by susceptible strains of bacteria. It is also effective in post-operative infections. It is also effective as prophylaxis and in the treatment of endophthalmitis. Vofox (Levofloxacin) also indicated for the treatment of corneal ulcer & other severe infections caused by susceptible strains of bacteria.
Dosage & Administration
Vofox (Levofloxacin) Sterile Eye Drops: Days 1 & 2 Instill 1 drop in the affected eyes every 2 hours while awake, up to 8 times per day. Days from 3 to 7 Instill 1 drop in the affected eyes every 4 hours while awake, up to 4 times per day.
Contraindication
Contraindicated in patients who are hypersensitive to Levofloxacin, to other quinolones or to any of the components in this preparation.
Side Effects
Most frequently reported side effects are transient decreased vision, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia.
Precautions
Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, Levofloxacin should be discontinued and alternative therapy should be instituted. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis or corneal ulcer. It should not be injected subconjunctivally or should not be introduced directly into the anterior chamber of the eye.
Drug Interaction
There is no clinical data and specific drug interaction studies have not been conducted with Levofloxacin eye drops.
Use in Pregnancy & Lactation
There are no adequate and well controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.
Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin is administered to a nursing mother.
Use in Children
Safety and effectiveness of levofloxacin in children below the age of 1 year have not been established.
Use in Elderly Patients
For elderly patients same safety or effectiveness have been observed like adult patients.
Storage
Store below 25˚C, protect from light and moisture. Keep out of the reach of children.
Note: Do not use longer than 30 days after first opening.
Packaging
Vofox eye drops: Each dropper contains 5 ml sterile eye drops.
