Moxigram-D

Composition

Each ml contains Moxifloxacin Hydrochloride USP equivalent to Moxifloxacin 5 mg & Dexamethasone Sodium Phosphate BP equivalent to Dexamethasone Phosphate1 mg.

Pharmacology

The mechanism of action of Moxifloxacin involves the inhibition of topoisomerase IV and DNA gyrase. Dexamethasone inhibits phospholipase A2 enzyme and thus inhibits prostaglandin synthesis and gives anti-inflammatory action.

Indications

Moxigram-D ophthalmic solution 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.

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.

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.

Precautions

• For ophthalmic use only

• 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

Side Effects

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

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

Use in pregnancy

There are no adequate and well-controlled studies in pregnant women. Moxifloxacin & Dexamethasone combination ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in Children

The efficacy and safety of Moxifloxacin & Dexamethasone combination ophthalmic solution in pediatric patients have not been established.

Use in lactation

Caution is advised when Moxifloxacin & Dexamethasone combination ophthalmic solution is given to nursing women

Packing

Each Plastic dropper bottle contains 5 ml sterile eye drops

Keep away from light & moisture and store below 30°C. Keep out of the reach of children. Use within one month after the first opening.