Opdex Ophthalmic Solution

Dexamethasone is glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.

For Ear:

• Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
• Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.

Pediatric Use: Safety and effectiveness in pediatric patients below 1 year have not been established.

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

Hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

Eye: The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness have been received. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Ear: The most common adverse effects are discomfort and ear pain. Others reported reactions are irritability, dizziness, erythema etc.

Pregnancy: There are no adequate and well controlled studies in pregnant women. This Sterile Eye & Ear Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. So, caution should be exercised when using this Sterile Eye & Ear Drops to a nursing mother.

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing and in patients with persistent corneal ulceration. Prolonged use of antibiotic may result in overgrowth of non-susceptible organisms. Prolonged use of topical ophthalmic steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored.

Aural steroid & antibiotic combined preparations

Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use. The drug is to be used within 30 days after first opening. The bottle is to be closed strongly immediately after use.