Dexalev Ophthalmic Solution

Dexalev ophthalmic solution is indicated for prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults.

Each ml sterile ophthalmic solution contains-

• Dexamethasone 1 mg (as Dexamethasone Sodium Phosphate USP)
• Levofloxacin 5 mg (as Levofloxacin Hemihydrate USP)

Preservative: Benzalkonium Chloride 0.005%.

Levofloxacin is a synthetic third-generation fluoroquinolone anti-bacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. Levofloxacin, the active L-isomer of ofloxacin that inhibits bacterial type II topoisomerases-DNA gyrase and topoisomerase IV. Levofloxacin preferentially targets DNA gyrase in Gram-negative bacteria and topoisomerase IV in Gram-positive bacteria. On the other hand, the action of Dexamethasone Phosphate is to inhibit the phospholipase A 2 , the first step in prostaglandin synthesis. Also, inhibits the chemotactic infiltration of neutrophils into the site of inflammation. Its anti-inflammatory activity is 30 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone. Like other glucocorticoids, it is anti-allergic, anti-exudative & anti-proliferative.

Adult: One drop is instilled into the conjunctival sac after surgery every 6 hours for 7 days.

Children and adolescents: This is not recommended for children and adolescents below 18 years due to a lack of data on safety and efficacy in this age group.

Instruction for use: If possible, ask someone else to apply the drops for you. Ask them to read these instructions with you before applying the drops.

• Wash carefully your hands.
• Open the bottle. Remove the loose collar from the cap when the bottle is first opened. Take special care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers.
• Twist off the bottle cap. Hold the bottle pointing down, between your thumb and fingers.
• Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here.
• Tilt your head back and bring the bottle tip close to the eye and squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard.
• After using this eye drop press a finger into the corner of your eye by the nose. This helps to stop the medicine getting into the rest of the body.

Tell your doctor or pharmacist-

• if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
• if you are applying any other type of eye drop or eye ointment before you start to use this eye drop.
• if you are using ocular NSAIDs (used against pain and inflammation in the eye) like ketorolac, diclofenac, bromfenac and nepafenac. Simultaneous use of ocular steroids and ocular NSAIDs may increase the potential for healing problems in your eye.
• if you are using ritonavir or cobicistat (used in HIV treatment), as these may increase the amount of dexamethasone in the blood.
• if you are using probenecid (to treat gout), cimetidine (to treat stomach ulcer) and cyclosporin (to prevent transplant rejection) as they may change absorption and metabolism of levofloxacin.

Contraindicated in hypersensitivity to any of the components of the formulation, herpes simplex keratitis, varicella, and another viral disease of the cornea and conjunctiva, mycobacterial infections of the eye, fungal diseases of ocular structures.

The most commonly reported non-serious adverse reactions are eye irritation, ocular hypertension and headache. An increase of intra-ocular pressure (IOP) of eyes and glaucoma may occur. Diabetics are also more prone to develop subcapsular cataracts following prolonged topical steroid administration. There are some possible adverse reactions related to cornea as like thinning of the cornea, perforation in some cases in cornea.

There are no or limited amount of data from the use of Dexamethasone and Levofloxacin in pregnant women. Corticosteroids cross the placenta. Prolonged or repeated corticosteroid use during pregnancy has been associated with an increased risk of lower birth weight and risk for high blood pressure, vascular disorders and insulin resistance in the adulthood. Dexamethasone and Levofloxacin are excreted into human milk. There is no
data available to indicate whether relevant amounts of Dexamethasone or Levofloxacin are transferred into human breast milk and which are capable of producing clinical effects in the infant. Caution should be exercised when the combination is administered to a nursing woman.

This eye drop is for ocular use only. Prolonged use may induce antibiotic resistance with the result of overgrowth of non-susceptible organisms, including fungi. If an infection develops, the treatment should be discontinued and alternative therapy used. Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension/glaucoma but this is unlikely when This eye drop is used for the recommended treatment period (7 days).

Overdose through local or accidental oral administration is not likely. An overdose of this medication is unlikely to threaten life.

Store below 30°C and dry place, away from light. Keep out of the reach of children, do not touch the tip of the dropper bottle since this may contaminate the product. Do not use after 1 month of first opening of the dropper.