Dexalev (Dexamethasone 0.1% & Levofloxacin 0.5%)
Dexalev Ophthalmic Solution, we are introducing from Aristovision, and this combination is a new era of eye care excellence. It is a new fixed-dose combination (FDC) of levofloxacin and dexamethasone offers only 7-day therapy approved by MHRA & EMA than other combinations of topical antibiotic/corticosteroid. It is indicated for the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after ocular surgery.
Description
Dexalev Ophthalmic Solution is a new fixed dose combination (FDC) of levofloxacin and dexamethasone offers only 7-days therapy approved by MHRA & EMA than other combination of topical antibiotic/corticosteroid. It is indicated for the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after ocular surgery. 7 days combination (Dexamethasone & Levofloxacin) therapy followed by dexamethasone alone for next 7 days, prevents infections and reduces inflammation (95.2%) and pain & discomfort (95%) after ocular surgery. In the meantime, Levofloxacin is a fluoroquinolone antibacterial agent, has wide spectrum of activities against different gram-positive microorganisms (e.g. S. aureus MSSA, S. pyogenes, S. pneumoniae, viridans group streptococci), aerobic Gram-negative bacteria (e.g. E. coli, H. influenzae, M. catarrhalis, P. aeruginosa community isolates), other organisms (e.g. Chlamydia trachomatis). Beside this Dexalev is manufactured with European raw material from Spain.
Presentation
Dexalev Ophthalmic Solution: Each ml contains Dexamethasone Sodium Phosphate USP equivalent to Dexamethasone 1 mg & Levofloxacin Hemihydrate USP equivalent to Levofloxacin 5 mg.
Indications
Dexalev ophthalmic solution is indicated in the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after eye surgery.
Dosage & Administration
One drop is instilled into the conjunctival sac after surgery every 6 hours. The duration of treatment is 7 days. If one dose is missed, treatment should continue with the next dose as planned or as directed by the physician.
Contrainidications
Contraindicated in patients with hypersensitivity to active substance levofloxacin or to other quinolones, to dexamethasone, or to other steroids, or to any of the excipients.
Warning & Precautions
For ophthalmic use only.
- Prolonged use may induce antibiotic resistance with the result of overgrowth of non-susceptible organisms, including fungi.
- Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension/glaucoma. In any case, it is advisable that the intraocular pressure be checked frequently.
- Topical ophthalmic corticosteroids may slow corneal wound healing
Side effects
In clinical studies, 438 patients have been treated with Dexamethasone & Levofloxacin fixed dose combination ophthalmic solution. No serious adverse reactions occurred. The most commonly reported non-serious adverse reactions are eye irritation, ocular hypertension, and headache.
Drug interaction
No interaction studies have been performed.
Use in special groups
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Pediatric: Safety and effectiveness in children and adolescents below the age of 18 years have not been established.
Use in Elderly Patients: No dosage adjustment in elderly patients is necessary.
Packing
Dexalev Ophthalmic Solution: Each LDPE dropper bottle contains 5 ml of Sterile Eye Drops.
