Moxifloxacin Hydrochloride + Dexamethasone

Indications

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.

Pharmacology

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.

Dosage And Administration

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.

Contraindications

Hypersensitivity to quinolones. Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella & other viral diseases of cornea & conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Glaucoma & diseases causing thinning of cornea or sclera.

Side Effects

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.

Pregnancy And Lactation

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.

Precautions And Warnings

For ophthalmic use only. The solution should not be injected under the conjunctiva, nor introduced directly into the anterior chamber of the eye. Prolonged use of steroids may result in ocular hypertension.

Overdose Effects

No information is available on overdosage with this product in humans.

Therapeutic Class

Ophthalmic Steroid preparations.

Use in special populations

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.

Storage Conditions

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.