Tobradex Ophthalmic Ointment 3.5 g

Tobradex Ophthalmic Ointment 3.5 g

Composition:

Tobramycin 0.3% w/w,
dexamethasone 0.1% w/w.
Other Ingredients:
Chlorobutanol, mineral oil, petrolatum base.

Product Description:

A combined ophthalmic preparation containing dexamethasone, a corticosteroid that blocks inflammatory mediators, and tobramycin, an aminoglycoside antibiotic that inhibits bacterial growth.
Together they provide anti‑inflammatory and antibacterial effects for the treatment of eye conditions.

Indications for Use:

• Inflammatory eye diseases with actual or potential bacterial infection.
• Chronic inflammation of the uveal tract.
• Eye injuries caused by chemical, radiation, or thermal burns.
• Eye injuries due to foreign bodies.
• Effective only against bacterial infections (not viral or fungal).

Method of Administration and Dosage:

• Adults: Apply a ribbon of ointment about 1.5 cm into the conjunctival sac of the affected eye(s) 3–4 times daily.
• May be combined with Tobradex suspension (e.g., at bedtime). 
• When using other ophthalmic preparations, allow at least 5 minutes between applications; ointments should be applied last. 
• In case of overdose, rinse with warm water.
• Do not double the dose if one is missed.

Contraindications:

• Hypersensitivity to tobramycin, dexamethasone, or other components.
• Allergy to aminoglycoside antibiotics.
• Herpes simplex keratitis.
• Varicella or other viral eye infections.
• Fungal or parasitic eye infections.
• Mycobacterial eye infections, including tuberculosis.
• Active untreated eye infections.

Precautions:

• Not tested in children under 18 years.
• Long‑term use increases risk of glaucoma, cataract, elevated intraocular pressure, and infections.
• Regular monitoring of intraocular pressure is required during prolonged therapy.
• Contact lens use is not recommended during treatment.
• Caution in patients with myasthenia gravis, Parkinson’s disease, or diabetes.
• Inform physician about concomitant medications (NSAIDs, antivirals, HIV treatments such as ritonavir or cobicistat).
• Vision may be blurred immediately after application; avoid driving or operating machinery until vision clears.
• Keep out of reach of children.

Adverse Reactions / Side Effects:

• Common: eyelid redness or swelling, tearing, dry eyes, ocular allergy, irritation, pain, itching, blurred vision, headache, nausea, metallic taste, skin rash, eyelid drooping.
• Rare: severe allergic reactions (facial swelling, difficulty breathing, hives, erythema multiforme, blisters), increased intraocular pressure, glaucoma, cataract, serious vision problems.

Pregnancy and Lactation:

Use only under medical supervision.

Storage Conditions:

Store at temperatures not exceeding 25 °C, in a dry place, away from direct sunlight.

Packaging:

Cardboard box containing a 3.5 g tube and leaflet.