Generic

Dexamethasone + Tobramycin

Indications

T-Mycin Plus Ophthalmic Suspension & Ointment 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.

Pharmacology

The bactericidal activity of Tobramycin is accomplished by specific inhibition of protein synthesis in susceptible bacteria. Dexamethasone, a potent corticosteroid, suppresses the inflammatory response to chemical, immunological or mechanical irritants.

Dosage & Administration

Ophthalmic Suspention: 1 drop into the conjunctival sac every 4 hours. During the initial 24 to 48 hours the dosage may be increased to 1 drop every 2 hours. Frequency should be decreased gradually by improvement in clinical signs.

Eye ointment: It should be applied thinly and evenly into the conjunctival sac(s) up to 3 or 4 times daily or may be used adjunctively with drops at bedtime.

Interaction

This combination eye drop has not been subjected to any particular interaction studies. In the case of simultaneous therapy with other topical ophthalmic drugs, a 10-minute delay between applications should be given.

Contraindications

Herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and many other viral diseases of the cornea and conjunctiva. Hypersensitivity to any component of this medication.

Side Effects

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

Pregnancy & Lactation

It has not been determined whether or not it is safe to use during pregnancy and lactation in humans.

Precautions & Warnings

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. Prolonged use of antibiotic may result in overgrowth of nonsusceptible 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.

Therapeutic Class

Combinations of ophthalmic steroid and antibiotic formulations

Storage Conditions

Allow to cool to room temperature before using. After each usage, immediately close the bottle. After opening the bottle, do not use it for more than one month.

Pharmaceutical Name

Aristopharma Ltd.