Trevox D 0.1%+0.5%

INDICATIONS

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

PHARMACOLOGY

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.

DOSAGE

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.

INTERACTION

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.

SIDE EFFECTS

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.

PREGNANCY & LACTATION

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 nodata 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.

PRECAUTIONS & WARNINGS

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).

STORAGE CONDITIONS

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.