Tobradex Sterile Ophthalmic Suspension 5 ml

Tobradex Sterile Ophthalmic Suspension 5 ml

Composition:

Each ml of suspension contains:
Tobramycin 0.3% (3 mg) and Dexamethasone 0.1% (1 mg).
Excipients include:
benzalkonium chloride (as a preservative), disodium edetate, sodium chloride, tyloxapol, hydroxyethylcellulose, sodium sulfate, and purified water, with sulfuric acid and/or sodium hydroxide added for pH adjustment.

Product Description:

Tobradex is a sterile ophthalmic combination containing an aminoglycoside antibiotic and a potent corticosteroid.
Tobramycin provides broad-spectrum bactericidal activity by inhibiting protein synthesis in susceptible bacterial pathogens, while dexamethasone suppresses inflammatory responses such as edema, fibrin deposition, and capillary dilation.
This synergistic combination treats ocular inflammation when a bacterial infection coexists or when there is a high risk of superficial bacterial infection.

Indications for Use:

Steroid-responsive inflammatory ocular conditions where a corticosteroid is indicated and a superficial bacterial eye infection exists or a risk of infection exists.
Ocular inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis).
Chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Method of Administration and Dosage:

• The medication is for topical ophthalmic use only.
• Shake the bottle well before each use.
• Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours. 
• During the initial 24 to 48 hours, the dosage may be increased to 1 to 2 drops every 2 hours. 
• Treatment frequency should be gradually decreased as clinical signs improve, and care should be taken not to discontinue therapy prematurely.

Contraindications:

Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella.
Mycobacterial infection of the eye and fungal diseases of ocular structures.
Hypersensitivity to tobramycin, dexamethasone, or any other component of the formulation.

Precautions:

• Prolonged use of topical ocular corticosteroids may result in ocular hypertension or 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 during therapy.
• Corticosteroid therapy may mask signs of infection or enhance susceptibility to secondary ocular infections, including fungal invasions during prolonged corneal ulceration. 
• Contact lenses should not be worn during treatment with this product.

Adverse Reactions / Side Effects:

Ocular Side Effects: localized ocular toxicity and hypersensitivity (including conjunctival erythema, eyelid itching and swelling, and lacrimation); elevation of intraocular pressure; glaucoma; delayed wound healing; subcapsular cataract formation; secondary fungal or bacterial ocular infections.
Systemic Side Effects: systemic absorption may occur with intensive topical use, occasionally causing headache, dizziness, or systemic corticosteroid effects.

Pregnancy and Lactation:

Topical corticosteroid and aminoglycoside use during pregnancy should be considered only if the potential benefit to the mother justifies the potential risk to the fetus.
Caution should be exercised when Tobradex is administered to a nursing woman, and a decision should be made to either discontinue nursing or discontinue the medication.

Storage Conditions:

Store at room temperature between 8 °C and 25 °C.
Keep the bottle upright, tightly closed when not in use, and out of reach of children.

Packaging:

The cardboard box contains a 5 ml plastic dropper bottle of sterile ophthalmic suspension and a medical instruction insert.