Flomox D Ophthalmic Solution

Moxifloxacin & Dexamethasone eye drop 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.

Each ml contains-

• Moxifloxacin Hydrochloride BP equivalent to Moxifloxacin 5 mg &
• Dexamethasone Sodium Phosphate USP equivalent to Dexamethasone Phosphate 1 mg.

Moxifloxacin is a broad spectrum 4th generation fluorinated quinolone. It inhibits both topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Dexamethasone is a cortisone derivative that shows high activity due to the presence of methyl group in the 16-alpha position and of a fluorine atom in the 9-alpha position. Like other glucocorticoids, it is anti-allergic, anti-exudative and anti-proliferative. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

In the prevention of infection and post-surgical ocular inflammation: Instill 1 drop, 4 times a day, in the eye to be operated, from 1 day before surgery until 15 days after surgery.

In patients undergoing cataract surgery: The day of surgery instill the medication immediately after eye surgery.

In patients undergoing LASIK refractive surgery: On the day of surgery instill the medication at least 15 minutes after ocular surgery.

In eye infections caused by susceptible microorganisms: Instill 1 drop, 4 times a day, for up to 7 days.

Hypersensitivity to other quinolones and any components of the product. Patients with glaucoma and/or ocular disease causing thinning of the cornea or sclera; inflammation in the eye caused by virus, fungi or mycobacteria. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea, and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures.

Moxifloxacin: Conjunctivitis decreased visual acuity, dry eye, keratitis, Ocular discomfort, hyperemia, pain, Subconjunctival hemorrhage and tearing.

Dexamethasone: Visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response & perforation of the globe.

There are no adequate and well-controlled studies in pregnant women. Moxifloxacin & Dexamethasone combination eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution is advised when Moxifloxacin & Dexamethasone combination eye drops is given to nursing women.

If an allergic reaction to Moxifloxacin occurs, discontinue use of the product and contact with doctor. Prolonged steroid use may result in ocular hypertension and/or glaucoma with damage to the optic nerve, defect in visual acuity and fields of vision, posterior subcapsular cataract formation, or increased hazard of developing secondary ocular infections. The intraocular pressure must be evaluated routinely. In those diseases causing thinning of the cornea or sclera (white part of the eye), perforations have been known to occur with use of topical corticosteroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.

Use in the elderly: No change in dosage is required when the product is administered in elderly patients.

Use in Children: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.

No information is available on overdosage with Flomox D in humans.

Ophthalmic Steroid preparations

Store in a cool place, below 30°C, 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 30°C. Discard after the 28 days. Keep out of reach of children.