Infladex-TN Ophthalmic Solution

This sterile Eye Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA. The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

Insert 1 drop into the conjunctival sac 3-5 times per day. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every 2 hours.

No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium. Fungal diseases of ocular structures. Untreated purulent infection of the eye. Hypersensitivity to any component of the medication.

The most frequent side effects to topical ocular Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjuntival erythema. The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsule cataract formation.

Safety for use during pregnancy and lactation in humans has not been established

Shake the bottle well before use. To prevent contamination do not touch the tip of the bottle to affected eye, eyelid or any surface of of the affected eye. Keep the bottle tightly closed after use.

Overdose of this eye drops may be flushed from the eye(s) with lukewarm tap water.

Ophthalmic steroid - antibiotic combined preparations

Use in paediatric: Safety and effectiveness in paediatric patients below 2 years have not been established.

Store at room temperature. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.