1. COMPOSITION
Each mL contains:
• Tobramycin 3 mg (0.3% w/v).
• Dexamethasone 1 mg (0.1% w/v).
• Benzalkonium Chloride 0.1 mg (0.01% w/v).
• Excipients: As applicable.
• Sterile aqueous vehicle q.s. 2. PHARMACEUTICAL FORM
Sterile ophthalmic suspension for topical ocular administration. 3. THERAPEUTIC CLASS
Ophthalmic Antibiotic – Corticosteroid Combination. 4. INDICATIONS
Tobramycin and Dexamethasone Eye Drops are indicated for steroid-responsive inflammatory ocular conditions where a superficial bacterial infection or risk of bacterial infection exists, including:
• Inflammatory conditions of the conjunctiva.
• Inflammatory conditions of the eyelids.
• Other steroid-responsive inflammatory conditions of the anterior segment of the eye where antibacterial therapy is appropriate. Treatment should be guided by the clinical diagnosis and applicable ophthalmic treatment guidelines. 5. CONTRAINDICATIONS
• Hypersensitivity to tobramycin, dexamethasone, aminoglycosides, benzalkonium chloride, or any component of the formulation.
• Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis.
• Fungal diseases of ocular structures.
• Mycobacterial infections of the eye. 6. DRUG INTERACTIONS
• Concurrent use with other aminoglycosides may increase the risk of toxicity if significant systemic absorption occurs.
• Other ophthalmic preparations should generally be administered with an appropriate interval between applications.
• The treating physician should review all concomitant medications before use. 7. ADMINISTRATION
For topical ophthalmic use only. Instill the prescribed number of drops into the affected eye(s) according to the approved product information. Shake well before use. Do not touch the dropper tip to the eye or surrounding surfaces. If using other ophthalmic preparations, separate administration by an appropriate interval. 8. STORAGE
Store according to the storage conditions stated on the approved product label. Protect from excessive heat, moisture and light. Keep the container tightly closed when not in use. Do not use if the suspension shows visible particles, unexpected discoloration or other abnormal changes.
Market : international export Private Label : Avilable Registration Support : Avilable Regulatory documents : Avilable on request | 