This ophthalmic combination solution is used in adults for the prevention and treatment of inflammation, as well as for preventing infections associated with cataract surgery.

Each mL of 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 antibacterial agent that works by inhibiting the supercoiling activity of bacterial DNA gyrase, thereby stopping DNA replication. It is the active L-isomer of ofloxacin and acts by targeting bacterial type II topoisomerases, including DNA gyrase and topoisomerase IV. In Gram-negative bacteria, it primarily acts on DNA gyrase, while in Gram-positive bacteria, it mainly targets topoisomerase IV. On the other hand, Dexamethasone Phosphate works by inhibiting phospholipase A2, which is the initial step in prostaglandin synthesis. It also reduces the chemotactic movement of neutrophils to the site of inflammation. Its anti-inflammatory effect is about 30 times stronger, and its overall therapeutic efficacy is 8–10 times greater than hydrocortisone. Like other glucocorticoids, it also exhibits anti-allergic, anti-exudative, and anti-proliferative properties.

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 may use any other medicines, including non-prescription medicines.
• Inform them if you are using any other eye drops or eye ointments before starting this medication.
• Mention if you are using ocular NSAIDs such as ketorolac, diclofenac, bromfenac, or nepafenac, as using them with ocular steroids may increase the risk of delayed eye healing.
• Inform your doctor if you are taking ritonavir or cobicistat (used in HIV treatment), as they may increase dexamethasone levels in the blood.
• Also inform them if you are using probenecid (for gout), cimetidine (for stomach ulcers), or cyclosporine (to prevent transplant rejection), as these may affect the absorption and metabolism of levofloxacin.

This medicine is contraindicated in patients who are hypersensitive to any of its components. It should not be used in cases of herpes simplex keratitis, varicella (chickenpox), or other viral infections affecting the cornea and conjunctiva. It is also not indicated for ocular mycobacterial infections or fungal diseases of the eye structures.

The most frequently reported non-serious side effects include eye irritation, increased intraocular pressure, and headache. Elevated intraocular pressure may lead to ocular hypertension or glaucoma. Patients with diabetes are at a higher risk of developing subcapsular cataracts after prolonged use of topical steroids. There are also potential corneal-related adverse effects, such as thinning of the cornea, and in rare cases, corneal perforation.

There are limited or no adequate data on the use of Dexamethasone and Levofloxacin in pregnant women. Corticosteroids can cross the placenta, and prolonged or repeated use during pregnancy has been linked to an increased risk of low birth weight, as well as a higher risk of hypertension, vascular disorders, and insulin resistance later in life. Both Dexamethasone and Levofloxacin are excreted in human breast milk. However, there is insufficient information on whether clinically significant amounts of these drugs pass into breast milk or affect the nursing infant. Therefore, caution should be exercised when this combination is administered to breastfeeding women.

This eye drop is intended for ocular use only. Extended or prolonged use may lead to the development of antibiotic resistance, resulting in the overgrowth of non-susceptible organisms, including fungi. If an infection occurs, treatment should be stopped and an alternative therapy should be initiated. Long-term use of topical ophthalmic corticosteroids may cause ocular hypertension or glaucoma; however, this risk is unlikely when this eye drop is used for the recommended treatment duration of 7 days.

Overdose due to local use or accidental oral ingestion is unlikely. Even in the event of an overdose, it is not expected to be life-threatening.

Store the product below 30°C in a dry place, protected from light. Keep it out of reach of children. Avoid touching the tip of the dropper bottle, as this may contaminate the solution. Do not use the product after one month from the first opening of the dropper.