Vigadexa

Vigadexa

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Moxifloxacin HCl 0.5%, dexamethasone Na phosphate 0.1%
Indications/Uses
Ocular infections caused by susceptible microorganisms. Prevention of inflammation & bacterial infection after ocular surgery.
Dosage/Direction for Use
Prevention of post-op ocular inflammation & infection Instill 1 drop qid in the eye, starting 1 day pre-op & during 15 days post-op. Cataract surgery Instill immediately post-op. Refractive surgery by LASIK Instill w/in 15 min post-op. Ocular infections caused by susceptible organisms Instill 1 drop qid for 7 days.
Contraindications
Hypersensitivity to moxifloxacin, dexamethasone or other quinolones. Herpes simplex keratitis, vaccinia, varicella & other viral infections of the cornea or conjunctiva. Fungal diseases of ocular structures or untreated parasitic eye infections. Mycobacterial ocular infection.
Special Precautions
Discontinue use if allergic reaction to moxifloxacin, first sign of tendon rupture, superinfection occurs. Prolonged use may result in ocular HTN &/or glaucoma w/ damage to the optic nerve, reduced acuity & visual field defects, posterior subcapsular cataract formation; may cause overgrowth of nonsusceptible organisms including fungi. Cushing's syndrome &/or adrenal suppression may occur after intensive or long-term continuous therapy in predisposed patients especially those treated w/ CYP3A4 inhibitors (including ritonavir & cobicistat). Discontinue if fungal infections occurs in patients w/ persistent corneal ulceration. Concomitant use w/ topical NSAIDs; superinfection. Monitor IOP routinely & frequently in patients receiving prolonged ophth corticosteroid therapy & w/ ocular HTN especially ped patients. Renal & hepatic impairment. Pregnancy, lactation. Ped patients <18 yr.
Adverse Reactions
Drug Interactions
Increased potential corneal healing problems w/ topical NSAIDs. Increased systemic exposure w/ CYP3A4 inhibitors (including ritonavir & cobicistat).
MIMS Class
Eye Antiseptics with Corticosteroids
ATC Classification
S03CA01 - dexamethasone and antiinfectives ; Belongs to the class of combinations of corticosteroids and antiinfectives used in ophthalmologic and otologic preparations.
Presentation/Packing
Form
Vigadexa ophth soln
Packing/Price
5 mL x 1's
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