Tobramycin and dexamethasone are commonly used in combination as eye drops. Tobramycin is an antibiotic that helps treat bacterial infections, while dexamethasone is a corticosteroid that reduces inflammation. This combination is often prescribed for eye conditions such as bacterial conjunctivitis (pink eye) or certain types of eye inflammation. The tobramycin works to kill the bacteria causing the infection, while the dexamethasone helps to reduce swelling, redness, and irritation in the eye.
TobraDex contains tobramycin and dexamethasone. It is available as eye drops and ointments for the therapy of inflammatory conditions of the eyes where the risk of bacterial infection exists. Tobrex alone can be advised where inflammation is not marked and bacterial infection is there.
Tobramycin and dexamethasone Uses:
- Ocular inflammatory conditions:
- Utilized to treat steroid-responsive ocular inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (where either a superficial bacterial ocular infection exists or there is a risk of bacterial ocular infection); chronic anterior uveitis; corneal injury from chemical, radiation, or thermal burns; and foreign body penetration.
Tobramycin and Dexamethasone Dose in Adults
Tobramycin and Dexamethasone Dose in the therapy of Ocular inflammatory conditions: Ophthalmic:
Ointment:
- Put a small amount of ointment (about the size of a small ribbon) in the affected eye(s) 3 to 4 times a day.
Suspension (Eye Drops):
- For TobraDex: Put 1 to 2 drops in the affected eye(s) every 4 to 6 hours. Your doctor might tell you to use it more often, like every 2 hours, for the first day or two, then less often as your eye gets better.
- For TobraDex ST: Put 1 drop in the affected eye(s) every 4 to 6 hours. Your doctor might say to use it more often, like every 2 hours, for the first day or two, then less often as your eye improves.
Tobramycin and Dexamethasone Dose in Children
TobraDex Dose in the treatment of Ocular inflammatory conditions:
- Children ≥2 years and Adolescents:
- See adult dosing.
Pregnancy Risk Category: N
- When using eye medications containing corticosteroids during pregnancy, it's essential to be cautious because studies in animals have shown some adverse effects.
- If you need to use these medications, it's best to use the lowest effective dose and also consider punctual occlusion to minimize the amount of medication that reaches the fetus.
- For more detailed information on each medication, refer to their individual descriptions.
Use during breastfeeding:
- It's uncertain whether tobramycin and dexamethasone, when applied topically, can be detected in human breast milk.
- The manufacturer advises caution when using tobramycin/dexamethasone eye drops while breastfeeding.
- For more detailed information on each medication, refer to their individual descriptions.
Tobramycin and Dexamethasone Dose in Kidney Disease:
- The manufacturer's instructions do not include dosage adjustments for renal impairment, as systemic absorption of the medication is typically low when applied topically.
- Therefore, dosage adjustment is unlikely to be necessary for individuals with renal impairment.
- For more detailed information on each medication, refer to their individual descriptions.
Tobramycin and Dexamethasone Dose in Liver disease:
- The manufacturer's instructions do not specify dosage adjustments for hepatic impairment because systemic absorption of the medication is typically low when applied topically.
- Therefore, dosage adjustment is unlikely to be necessary for individuals with hepatic impairment.
- For more detailed information on each medication, refer to their individual descriptions.
Side effects of Tobramycin and Dexamethasone (TobraDex):
- Dermatologic:
- Allergic Contact Dermatitis
- Miscellaneous:
- Wound Healing Impairment
- Infection:
- Secondary Infection
- Ophthalmic:
- Keratitis
- Lacrimation
- Swelling Of Eye
- Cataract
- Conjunctival Erythema
- Eyelid Pruritus
- Glaucoma
- Increased Intraocular Pressure
- Optic Nerve Damage
Contraindications to Tobramycin and dexamethasone (TobraDex):
- People who have a known allergy to tobramycin, dexamethasone, or any ingredients in the medication should not use it.
- It's also not suitable for those with certain viral infections of the cornea and conjunctiva, such as herpes simplex keratitis or varicella, as well as mycobacterial or fungal eye infections.
- In Canada, additional contraindications include known or suspected allergies to other aminoglycosides, after simple removal of a corneal foreign body, or in cases of untreated parasitic or acute purulent eye infections.
- While there's limited documentation on allergic reactions to corticosteroids, due to similarities in structure and function, cross-sensitivity may be possible.
Warnings and precautions
Hypersensitivity reactions
- Some people might be sensitive to aminoglycoside medications when applied on the skin or in the eyes.
- If you notice any signs of sensitivity, like irritation or redness, stop using the medication and talk to your doctor.
- There's a chance you could also be sensitive to other similar antibiotics in the aminoglycoside family.
Immunosuppression:
- Using corticosteroids for a long time can weaken the immune system and raise the risk of getting other infections in the eyes, like fungal infections.
- They can also make it harder to spot or even make worse some types of eye infections that cause pus.
- If someone has a long-lasting sore on their cornea after using corticosteroids, a fungal infection might be the cause, so it's important to tell the doctor about it.
Ocular effects
- Using corticosteroids for a long time can cause several eye problems, like glaucoma, which is high pressure in the eyes.
- It can also hurt the nerve that connects the eye to the brain, mess up how well someone can see, and cause cloudy areas on the lens inside the eye, called cataracts.
- If someone already has glaucoma, corticosteroids can make it worse.
- Using steroids after cataract surgery can slow down healing and make it more likely for a pocket of fluid to form in the eye.
- If someone uses this product for more than 10 days, it's important to have their eye pressure checked regularly.
- Also, using steroids in eye conditions that make the cornea or sclera thin can make the eye tear.
Ocular herpes simplex
- If someone has had ocular herpes simplex before, it's super important to be really careful when using this medication.
- Corticosteroids like this one could make the herpes infection last longer and make it worse.
- So, if someone has a history of ocular herpes simplex, they need to be really cautious when using this medication, and it's a good idea to talk to a doctor about it first.
Tobramycin and dexamethasone: Drug Interaction
Risk Factor C (Monitor therapy) |
|
CYP3A4 Inhibitors (Strong) |
Dexamethasone serum concentration can rise (Ophthalmic). |
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) |
May intensify the negative or harmful effects of corticosteroids (Ophthalmic). When ophthalmic products are administered concurrently, the healing of ocular tissue may be delayed. |
Ritodrine |
Corticosteroids may intensify Ritodrine's harmful or hazardous effects. |
Monitoring parameters:
Monitoring and Evaluation:
- Intraocular Pressure: Keep an eye on the pressure inside the eye if using the medication for more than 10 days or if the person has glaucoma.
- Signs of Infection: Watch out for any signs or symptoms of a new infection.
- Re-evaluation: If the signs or symptoms don't go away after 2 days, it's important to get them checked again by a doctor.
How to administer Tobramycin and dexamethasone (TobraDex)?
Contact Lenses:
- Do not wear contact lenses while using this medication.
For Eye Use Only:
- Only use this medication on the eyes.
- Avoid touching the tip of the container to the eyelids or any other surfaces to prevent contamination.
Ointment Application:
- Place the ointment between the eyeball and the lower lid.
- The person should look downwards before closing their eye.
Suspension Application:
- Shake the suspension well before using.
- Tilt the head back, put the drops in the space between the eyeball and the lower lid, and then close the eye(s).
- Gently press on the inner corner of the eye for about a minute after applying the drops.
Mechanism of action of Tobramycin and dexamethasone (TobraDex):
Tobramycin:
- Mechanism of Action: Interferes with bacterial protein synthesis by attaching to the 30S ribosomal subunit, causing a defective bacterial cell membrane.
Dexamethasone:
- Mechanism of Action: Reduces inflammation by stopping neutrophils from moving to the site of inflammation, decreasing the production of substances that cause inflammation, and reversing increased permeability of blood vessels. It also suppresses the normal immune response.
For more detailed information on each medication, refer to their individual descriptions.
International Brand Names of Tobramycin and dexamethasone:
- TobraDex
- TobraDex ST
- Bralifex Plus
- Combidex
- Dexage T
- Duocom
- Infladex-TN
- Mytodex
- Orbidex T
- Orbidex-T
- Ramtrex
- Steron-T
- Tobesyn Eye Drop
- Tobicort
- Tobidex
- Tobracort
- Tobradex
- Tobragan D
- Tobral D
- Tobrasone
- Tobraxona
- Vitodex Eye Drop
- Xolof D
Tobramycin and dexamethasone Brand Names in Pakistan:
Tobramycin and dexamethasone Eye Drops 0.3 %w/v in Pakistan |
|
Amgydex |
Kobec Pharmacals |
Bracin-D |
Atco Laboratories Limited |
Bradex |
Azron Pharmaceuticals (Pvt) Ltd |
Bromycin-D |
Innvotek Pharmaceuticals |
Cindex |
Ethical Laboratories (Pvt) Ltd. |
Dexadron T |
Epoch Pharmaceutical |
Dicon Eye Drops |
Global Pharmaceuticals |
Eyebradex |
Barrett Hodgson Pakistan (Pvt) Ltd. |
Klozen |
Zinta Pharmaceuticals Industries |
Mebradex |
Medipak Limited |
Mydex |
Shaigan Pharmaceuticals (Pvt) Ltd |
Myret |
Rex Pharmaceuticals Pakistan |
Obradex |
Vega Pharmaceuticals Ltd. |
Ocutob-Dex |
Farmigea Pak (Pvt) Ltd. |
Ophth-Tobra-D |
Ophth-Pharma (Pvt) Ltd. |
Santodex |
Sante (Pvt) Limited |
Tobra-D |
The Schazoo Laboratories Ltd. |
Tobracin-D |
Helix Pharma (Private) Limited |
Tobradex |
Novartis Pharma (Pak) Ltd |
Tobramet |
Polyfine Chempharma (Pvt) Ltd. |
Todex |
Mascon Pharmacal |
Tobramycin and dexamethasone Eye Drops 0.35 %w/v in Pakistan |
|
Tobcydex |
Valor Pharmaceuticals |
Tobramycin and dexamethasone Eye Oint 0.3 %w/w in Pakistan |
|
Amgydex |
Kobec Pharmacals |
Ophth-Tobra-D |
Ophth-Pharma (Pvt) Ltd. |
Santodex |
Sante (Pvt) Limited |
Tobradex |
Novartis Pharma (Pak) Ltd |