Moxifloxacin & Dexamethasone eye drop is indicated for the treatment of eye infections caused by susceptible microorganisms. It is also used to prevent inflammation and bacterial infection that may occur after eye surgery.

Each ml contains

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

Moxifloxacin is a broad-spectrum 4th generation fluoroquinolone. It inhibits both topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is essential for replication, transcription, and repair of bacterial DNA, while topoisomerase IV plays a key role in the separation of chromosomal DNA during bacterial cell division.

Dexamethasone is a cortisone derivative with high activity due to the presence of a methyl group at the 16-alpha position and a fluorine atom at the 9-alpha position. Like other glucocorticoids, it has anti-allergic, anti-exudative, and anti-proliferative effects. It works by inhibiting phospholipase A2 (the first step in prostaglandin synthesis) and reducing neutrophil infiltration at 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 or any ingredient of the product. Patients with glaucoma and/or ocular diseases that cause thinning of the cornea or sclera; eye inflammation caused by viruses, fungi, or mycobacteria. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal infections of ocular structures.

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

Dexamethasone: Visual acuity and visual field defects, cataract formation, secondary ocular infection due to suppression of host response, and globe perforation.

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 used in nursing women.

If an allergic reaction to Moxifloxacin occurs, discontinue use and contact a doctor. Prolonged steroid use may cause ocular hypertension and/or glaucoma, optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, and increased risk of secondary ocular infections. Intraocular pressure should be monitored regularly. In diseases causing thinning of the cornea or sclera, perforation may occur with topical corticosteroids. In acute purulent eye infections, steroids may mask or worsen the infection.

Use in the elderly: No dosage adjustment is required.

Use in Children: Safety and efficacy in pediatric patients have not been established.

No information is available on overdose in humans.

Ophthalmic Steroid preparations

Store in a cool place below 30°C, protected from light. After opening, use within 28 days and may be stored at room temperature up to 30°C. Discard after 28 days. Keep out of reach of children.