TobraDex® (Dexamethasone + Tobramycin) 5 ml eye drops

What Is TobraDex®?

TobraDex® is an eye drop that combines two active ingredients: dexamethasone, a corticosteroid, and tobramycin, an antibiotic.

It is used to treat inflammation of the eye and prevent or manage bacterial infections.

This medication is available as a 5 ml suspension for use directly in the eye.

TobraDex® provides both anti-inflammatory and antibacterial effects, making it effective for a range of eye conditions.

It is particularly beneficial for treating eye inflammation that involves or risks bacterial infections.

What Are the Uses of TobraDex® Eye Drops?

TobraDex® is specifically formulated to manage steroid-responsive inflammatory eye diseases where the risk of bacterial infection exists or there is an existing infection. It is particularly useful for conditions such as:

• Inflammation of the palpebral and bulbar conjunctiva.
• Corneal and anterior eye segment inflammation.
• Chronic anterior uveitis.
• Corneal injuries from chemicals, radiation, thermal burns, or foreign objects.

TobraDex® is effective for treating cases where steroid treatment is required to manage inflammation, and there is a need for antibiotic therapy to manage or prevent bacterial infections. The antibiotic tobramycin is especially beneficial in treating infections caused by bacteria like Pseudomonas aeruginosa, which can be resistant to other antibiotics.

Who Should Avoid Using TobraDex®?

Not everyone can use TobraDex® safely. It should not be used by individuals with:

• Known allergy to tobramycin, dexamethasone, or any other components of the formulation.
• History of hypersensitivity to aminoglycosides.
• Active viral infections such as herpes simplex keratitis, chickenpox, or other viral corneal or conjunctival infections.
• Fungal infections of eye structures or untreated parasitic eye infections.
• Mycobacterial eye infections.
• Surface epithelial injuries that are restricted to the corneal epithelium.
• A simple removal of a foreign body from the cornea without complications.

What Precautions Should Be Taken Before Using TobraDex®?

Using TobraDex® requires careful attention to several important precautions to ensure safety and effectiveness:

• Allergic Reactions: Patients with hypersensitivity to aminoglycosides may experience a range of reactions, from local irritation to systemic allergic responses like itching, redness, rash, or even anaphylaxis. If any signs of hypersensitivity develop, discontinue the medication immediately.
• Cross-Sensitivity Risk: Individuals allergic to tobramycin may also be sensitive to other aminoglycosides, whether applied locally or systemically. Monitoring for allergic reactions is crucial.
• Risk of High Eye Pressure: Prolonged or excessive use of corticosteroid-containing eye drops, such as TobraDex®, can increase the risk of elevated intraocular pressure, potentially leading to glaucoma, optic nerve damage, reduced visual acuity, or cataracts. It is important to monitor intraocular pressure regularly, particularly if used for over ten days, even though it may be challenging for pediatric patients or those who have difficulty with eye exams.
• Systemic Effects: Corticosteroids, even when used locally in the eye, can sometimes be absorbed and suppress the hypothalamic-pituitary-adrenal (HPA) axis, leading to systemic side effects like Cushing’s syndrome or reduced growth rates in children. Long-term high-dose use should be avoided, and if necessary, gradual discontinuation is recommended to minimize systemic effects.
• Suppression of Immune Response: The immune-suppressive effect of steroids may reduce resistance to bacterial, viral, fungal, or parasitic infections, making it easier for these pathogens to establish infections or for existing infections to worsen. Patients with persistent corneal ulceration should be evaluated for fungal involvement.
• Interaction with Contact Lenses: TobraDex® contains benzalkonium chloride, which can be absorbed by soft contact lenses and cause irritation. Patients are advised to remove contact lenses before application and wait at least 15 minutes before reinserting them.

How Should You Use TobraDex® Eye Drops?

Recommended Dosage: The usual dose for adults and children over the age of 8 is one to two drops in the affected eye(s) every four to six hours. In the first 24-48 hours, this can be increased to every two hours if needed for severe symptoms. As improvement occurs, the frequency of administration should be gradually reduced.

Application Instructions:

1. Shake the bottle well before use.
2. Wash your hands thoroughly.
3. Tilt your head back slightly and pull down your lower eyelid to create a small pocket.
4. Hold the dropper above the eye and squeeze out the prescribed number of drops.
5. After applying the drops, close your eyes for 2 minutes and apply gentle pressure to the inner corner of your eye to prevent drainage through the tear duct.
6. Avoid touching the dropper tip to prevent contamination.

Possible Side Effects of TobraDex®

TobraDex® may cause side effects, although not everyone will experience them. These side effects include:

• Common Side Effects: Increased intraocular pressure, eye discomfort, itching, and blurred vision.
• Less Common Side Effects: Allergic reactions such as eyelid swelling, eye redness, or periocular pain.
• Rare Side Effects: Serious effects like keratitis, cataracts, optic nerve damage, delayed wound healing, and suppression of adrenal gland function.

If any severe side effects occur, such as significant visual disturbances, intense pain, or signs of allergic reactions, contact your healthcare provider immediately.

How Should TobraDex® Be Stored?

Store TobraDex® at temperatures not exceeding 30°C (86°F). Keep the bottle upright and in a secure place out of the reach of children. After opening, use within four weeks and do not use past the expiration date.

Important Usage Notes:

• Do not discontinue treatment suddenly to avoid potential rebound inflammation or infection flare-ups.
• If using multiple types of eye medications, wait at least five minutes between applications, with ointments applied last.
• TobraDex® is intended for ophthalmic use only. It should not be injected or taken orally.

Can TobraDex® Be Used During Pregnancy or Breastfeeding?

• Pregnancy: There are limited data regarding the use of tobramycin and dexamethasone during pregnancy. Use of corticosteroids during pregnancy may carry risks, such as delayed fetal growth. It is generally advised to avoid using TobraDex® during pregnancy unless absolutely necessary.
• Breastfeeding: It is not known whether dexamethasone and tobramycin are excreted in human breast milk after topical use. Therefore, caution is advised. A decision should be made whether to discontinue breastfeeding or to stop using the medication based on the importance of treatment for the mother.

Can TobraDex® Affect the Ability to Drive or Use Machines?

TobraDex® may cause temporary blurred vision or other visual disturbances.

If this occurs, patients should wait until vision clears before driving or operating machinery.

Safety is of utmost importance, so avoid such activities until you are certain your vision is unimpaired.