Moxifloxacin Hydrochloride + Dexamethasone

Generic Name

Moxifloxacin Hydrochloride + Dexamethasone

Therapeutic Class: Anti-bacterial Ophthalmic Steroid preparations

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.

Presentation:
Each ml contains-

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

Description:
This Eye Drop is a combination of a fourth-generation fluoroquinolone Moxifloxacin and a potent corticosteroid Dexamethasone. Moxifloxacin controls infection by inhibiting the DNA gyrase & Topoisomerase IV. Dexamethasone effectively controls inflammation by inhibiting the release of inflammatory mediators.

Dosage & 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.

Interaction:
Drug-drug interaction studies have not been conducted with Moxifloxacin & Dexamethasone combination eye drops

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 & Lactation:

• Use in pregnancy: 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.
• Use in lactation: Caution is advised when Moxifloxacin & Dexamethasone combination eye drops are given to nursing women.
• Pediatric use: The efficacy and safety of Moxifloxacin & Dexamethasone combination eye drops in pediatric patients have not been established.
• Use in the elderly: No change in dosage is required when the product is administered to elderly patients

Precautions & 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

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.

Overdose:
In case of excessive instillation in the eye, rinse with sufficient warm water. Do not instill the product again until the time of the next dose.

Storage:
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 28 days. Keep out of reach of children.