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THERAPEUTIC CLASSIFICATION:

Corticosteroids and anti-infectives in association, ophthalmic use

 

COMPOSITION

TOBRAMYCIN / DEXAMETHASONE 3 mg / 1 mg per 1 mL of ophthalmic suspension

SUSPENSION

 

USES AND ADMINISTRATION

Dexatobrin is an association of: corticosteroid inhibitor of inflammatory response and bactericidal aminoglycoside component, potent, broad spectrum, which acts on bacterial cells by inhibiting the synthesis and binding of polypeptides on the ribosome.

 

INDICATIONS:

Dexatobrin ophthalmic suspension is indicated in inflammatory processes of the anterior segment of the eye that respond to treatment with steroids, associated with superficial bacterial ocular infection caused by microorganisms sensitive to tobramycin, or where there is a risk of such infection.

 

HOW TO USE:

2 drops in each eye every 4 hours, or according to medical indication.

 

CONTRAINDICATIONS:

Epithelial keratitis due to Herpes simplex (dendritic keratitis), vaccine, varicella and other viral pathologies of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal pathologies of ocular structures. Hypersensitivity to any component of the medication. The use of this preparation is always contraindicated after the simple extraction of a foreign body from the cornea.

 

“Contraindicated in pregnancy or when its existence is supposed”

 

ADVERSE EFFECTS:

Prolonged use of corticosteroids can cause ocular hypertension / glaucoma, optic nerve damage, alterations in visual acuity and visual fields, and posterior subcapsular cataract formation. Prolonged use can also cause secondary ocular infections due to the suppression of the body’s immune response. Acute purulent infections of the eye can be masked or enhanced by the presence of dexamethasone in the medication. Cases of perforation have been described with the topical use of steroids in those diseases that cause thinning of the cornea and sclera. It is recommended to check the intraocular pressure frequently.

 

Cushing’s syndrome and / or adrenal suppression associated with the systemic absorption of dexamethasone administered by ophthalmic route may occur after intensive or continued long-term treatment in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In these cases, the treatment should be interrupted progressively.

Some patients may be sensitive to topically administered aminoglycosides, in which case treatment should be discontinued.

The development of fungal infections of the cornea is especially favored in periods that coincide with prolonged treatment with topical steroids. The possibility of a fungal invasion in persistent ulcerations of the cornea should be considered when steroids are used or used.