TOBRADEX (dexamethasone/ tobramycine)

Key points

Maintenance of the favourable opinion for reimbursement in the local anti-inflammatory and antibacterial treatment of the eye in adults and children over the age of 2 years, following eye surgery.

Maintenance of the favourable opinion for reimbursement in the local anti-inflammatory and antibacterial treatment of the eye in adults and children over the age of 2 years of infections with an inflammatory component due to tobramycin-susceptible microorganisms, excluding infectious conjunctivitis.

Unfavourable opinion for reimbursement in other situations, including infectious conjunctivitis.

Role in the care pathwayEye surgery:

Eye surgery:

Given the available data and the validated care pathway, a fixed-combination ophthalmic corticosteroid + antibiotic treatment may be useful in the first-line treatment of inflammatory eye reactions following surgery and with the aim of preventing postoperative infectious complications in the eye. However, since the treatment durations differ for corticosteroids (treatment for several weeks with reduction of doses after 2 weeks of treatment) and antibiotics (until closure of incisions, i.e. 8 to 10 days maximum) and due to the risk of antibiotic resistance, these combinations are only useful for the antibiotic treatment period, i.e. 8 to 10 days maximum.

Role of the proprietary medicinal product in the care pathway:

TOBRADEX (dexamethasone, tobramycin) is a first-line treatment in the early management of infectious and inflammatory complications of the eye following eye surgery. Although the risk of antibiotic resistance is low with antibiotic eye drops, the correct use of antibiotics requires that their use be restricted. Consequently, their prescription must be limited to the antibiotic treatment duration (i.e. 8 to 10 days, until closure of incisions).

Eye infections:

In the context of the anti-inflammatory and antibacterial treatment of the eye during eye infections with an inflammatory component, the data supplied for these combinations does not support the benefit of using corticosteroid + antibiotic(s) ophthalmic products in these conditions. However, according to expert opinion, the combination of a topical corticosteroid with a topical antibiotic could be of benefit in rare situations in the event of a severe inflammatory reaction in case of blepharitis, a chalazion, a stye or a corneal abscess.

More specifically, in the event of a corneal abscess, a corticosteroid + antibiotic(s) combination may be administered once the infection has been controlled (for a very short period). In the event of a stye, this type of combination should be reserved for highly inflammatory recurrent forms.
Infectious conjunctivitis is generally viral and benign, resolving spontaneously with eye-washes. Antibiotic treatment is reserved for severe forms of infectious conjunctivitis and combination with a corticosteroid is not justified.

Role in the therapeutic strategy:

TOBRADEX (dexamethasone, tobramycin) is a second-line treatment in the local anti-inflammatory and antibacterial treatment of the eye, of eye infections with an inflammatory component due to tobramycin-susceptible microorganisms, excluding infectious conjunctivitis. Its prescription must be reserved for highly inflammatory forms and limited to the antibiotic treatment duration (i.e. 8 days maximum).

In other situations, including infectious conjunctivitis, this proprietary medicinal product has no role in the care pathway.