Dexalev Ophthalmic Solution, we are introducing from Aristovision, and this combination is a new era of excellence in eye care. It is a new fixed-dose combination (FDC) of levofloxacin and dexamethasone which offers only 7-day therapy 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 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. In the meantime, Levofloxacin is a fluoroquinolone antibacterial agent, has a 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

    According to clinical studies, no serious adverse reactions occurred. The most 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.