Dexatobrin Ophthalmic Suspension 5 ml

Dexatobrin 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 for pH adjustment.

Product Description:

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

Indications for Use:

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

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, avoiding premature discontinuation of therapy.

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 component of the formulation.

Precautions:

• Prolonged use of topical ocular corticosteroids may cause ocular hypertension or glaucoma, with damage to the optic nerve, visual acuity defects, and posterior subcapsular cataract formation.
• Intraocular pressure should be routinely monitored during prolonged 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 leading to systemic corticosteroid effects.

Pregnancy and Lactation:

Topical corticosteroid and aminoglycoside combinations should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Caution should be exercised when administered to a nursing woman, considering whether to discontinue nursing or discontinue the drug based on clinical necessity.

Storage Conditions:

Store at a temperature not exceeding 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.