NAVANA PHARMACEUTICALS LTD.
MOXIFLOXACIN HYDROCHLORIDE + DEXAMETHASONE PHOSPHATE
This combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.
Ophthalmic Steroid preparations
This Eye Drops is a combination of a fourth generation fluoroquinolone Moxifloxacin and a potent corticosteroid Dexmethasone. Moxifloxacin controls infection by inhibitting the DNA gyrase & Topoisomerase IV. Dexamethasone effectively controls the inflammation by inhibiting the release inflammatory mediators.
One or two drops instilled into the conjunctival sac(s), every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every two hours. Frequency must be decreased gradually or warranted by improvement in clinical signs. Care should be taken not to discontinue the therapy prematurely. Prevention of Post-Surgery Ocular Inflammation and Infection: Instill 1 drop, 4 times/day in the eye to be operated, starting 1 day before the surgery and during 15 days after the surgery. Treatment of Ocular Infections Caused by Susceptible Organisms: Instill 1 drop 4 times/day during 7 days, or as directed by the doctor. Observe the appearance of the medicine before using it. Patients Submitted to Cataract Surgery: Instil the solution immediately after the surgery. Patients Submitted to Refractive Surgery by LASIK: Instill the solution within 15 min after the surgery.
This ophthalmic solution is contraindicated in epithelial herpes simplex keratitis (Dendritic keratitis), vaccinia, varicella, and in many other viral diseases of the conjunctiva and cornea, Mycobacterial infection of the eye and fungal diseases of ocular structures and in individuals hypersensitive to any of the components of the medication.
The most frequently reported drug-related undesirable effects seen with Moxifloxacin are conjunctival irritation, increased lacrimation, keratitis and papillary conjunctivitis.
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. Caution should be exercised when Dexamethasone ophthalmic solution is administered to a nursing woman.
No information is available on overdosage with this product in humans.
Prolonged use of steroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
Store in a cool place, below 308C, protected from light. Once the container is opened the contents must be used within 28 days and may be stored at room temperature up to 308C. Discard after the 28 days. Keep out of reach of children