TobraDex contains tobramycin and dexamethasone. It is available as eye drops and ointments for the treatment 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:

  • Used for management of steroid-responsive ocular inflammatory conditions (where either a superficial bacterial ocular infection or the risk of bacterial ocular infection exists) of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe; chronic anterior uveitis; corneal injury from chemical, radiation or thermal burns; foreign body penetration.

Tobramycin and Dexamethasone Dose in Adults

Tobramycin and Dexamethasone Dose in the treatment of Ocular inflammatory conditions: Ophthalmic:

• Ointment:

  • Apply ~ 1/2 -inch ribbon in the conjunctival sac of the affected eye(s) up to 3 to 4 times per 24 hours

• Suspension:

  • TobraDex: 1 to 2 drops should be instilled into the conjunctival sac of the affected eye(s) every 4 to 6 hourly; may increase to 1 to 2 drops every 2 hours for the first 24 to 48 hours, can then reduce the frequency of intervals as signs and symptoms improve.
  • TobraDex ST: 1 drop should be instilled into the conjunctival sac of the affected eye(s) every 4 to 6 hourly; may increase to 1 to 2 drops every 2 hours for the first 24 to 48 hours, can then reduce the frequency of intervals as signs and symptoms improve.

Tobramycin and Dexamethasone Dose in Childrens

TobraDex Dose in the treatment of Ocular inflammatory conditions:

• Children ≥2 years and Adolescents:

  • See adult dosing.

Pregnancy Risk Category: N

• Studies on animal reproduction have shown adverse effects of topical steroids.
• If you are pregnant, use the lowest effective dose and punctual occlusion in combination to reduce potential exposure to your baby. Refer to individual agents.

Use during breastfeeding:

• It is unknown whether human milk may have systemic absorption. Pregnant women should be cautious when using topical agents. Refer to the individual agents.

Dose in Kidney Disease:

• No dosage adjustments provided in the manufacturer’s labeling.
• However, owing to the fact that systemic absorption is low, dosage adjustment unlikely.

Dose in Liver disease:

• No dosage adjustments provided in the manufacturer’s labeling.
• However, owing to the fact that systemic absorption is low, dosage adjustment unlikely.

Side effects of Tobramycin and Dexamethasone (TobraDex):

• Dermatologic:

  • Allergic Contact Dermatitis

• Infection:

  • Secondary Infection

• Ophthalmic:

  • Conjunctival Erythema
  • Eyelid Pruritus
  • Swelling Of Eye
  • Cataract
  • Glaucoma
  • Increased Intraocular Pressure
  • Keratitis
  • Lacrimation
  • Optic Nerve Damage

• Miscellaneous:

  • Wound Healing Impairment

Contraindications to Tobramycin and dexamethasone (TobraDex):

• Hypersensitivity to dexamethasone, tobramycin or any other component of the formulation
• Viral diseases of conjunctiva and cornea (epithelial herpes simplex [dendritic] keratitis], varicella, vaccinia)
• Mycobacterial infection of your eyes
• Fungal diseases of the ocular structure

Canadian labeling: Additional contraindications not in US labeling

• Hypersensitivity known or suspected to other aminoglycosides
• The corneal foreign body was removed easily.
• Acute purulent infections of eyes that are not treated or parasitic.

Warnings and precautions

• Hypersensitivity reactions

  • Sensitivity to topically applied aminoglycosides may occur. Stop the drug immediately if you experience sensitivity.
  • Cross-sensitivity may also occur to other aminoglycoside antimicrobials.

• Immunosuppression:

  • Long-term steroids may increase the likelihood of secondary ocular infections, including fungal infections.
  • This may mask or exacerbate acute purulent ocular infection.
  • Any patient suffering from persistent corneal ulceration after receiving steroid therapy should suspect fungal infection.

• Ocular effects

  • The development of glaucoma, damage to the optic nerve, visual defects such as acuity or field of vision, and the formation of posterior subcapsular and glaucoma may all be possible with long-term use.
  • Steroids can raise IOP so they should not be used in the presence of glaucoma.
  • Topical steroids can cause perforation in patients with sclera or thinned corneas.
  • Steroids after cataract surgery can cause delayed healing and increase the likelihood of bleb formation.
  • If this product is being used for longer than 10 days, it is important to monitor your intraocular pressure.

• Ocular herpes simplex

  • Patients with a history ocular herpes should exercise extreme caution when using steroid medication. Steroids can prolong the course of the infection and increase the severity.

Tobramycin and dexamethasone: Drug Interaction

Monitoring parameters:

• Intraocular pressure should be monitored with use >10 days and in patients with glaucoma
• Signs/symptoms of a secondary infection; if signs and symptoms persist beyond 48 hours, the patient should be re-evaluated.

How to administer Tobramycin and dexamethasone (TobraDex)?

• Do not wear contact lenses during therapy.
• Only use topically in eyes; container tip to eyelids or other surfaces should not be touched when placing drops or ointment in eyes to avoid contamination.

Ointment:

• Ointment should be applied into the pocket between the eyeball and lower lid; advise patient to look down before closing eye.

Suspension:

• Shake well before using.
• Tilt head back, instill suspension in the conjunctival sac and close eye(s).
• Light finger pressure should be applied on the lacrimal sac for 1 minute following instillation.

Mechanism of action of Tobramycin and dexamethasone (TobraDex):

• Tobramycin: Binds with ribosomal Subunit 30S, which affects bacterial protein synthesis. This causes a deficient bacterial cell membrane.
• Dexamethasone - The body's inflammatory response is reduced by the following mechanism
• Neutrophil migration/chemotaxis inhibition
• The decrease in the synthesis of mediators that are inflammatory
• Reversal of increased capillarypermeability
• Normal immune response suppressed

See individual agents.

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: