TOBRADEX STERILE OPHTHALMIC SUSPENSION [SIN04438P]

Product Info

TOBRADEX STERILE OPHTHALMIC SUSPENSION

[SIN04438P]

4.1 Therapeutic indications
TOBRADEX® contains tobramycin, an antibiotic, and dexamethasone, a corticosteroid.

TOBRADEX® is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

• Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

• Streptococci, including some of the Group A beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

• Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis. Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.

4.2 Posology and method of administration

TOBRADEX® ophthalmic Suspension
Adolescents and adults, including the elderly
1 or 2 drops instilled into the conjunctival sac(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to 1 or 2 drops every 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Pediatric patients
The safety and efficacy of TOBRADEX® ophthalmic suspension in children have not been established.

Hepatic or renal impairment
The safety and efficacy of TOBRADEX® ophthalmic suspension in patients with hepatic or renal impairment have not been established.

Method of administration

• For ocular use only.

• The bottle must be well shaken before use.

• After cap is removed, if tamper evident snap collar is loose, it should be removed before using the product.

• Keep the bottle tightly closed when not in use.

• To avoid contamination, the dropper tip should not touch any surface. The tip of the dropper/ tube should also not come into contact with the eye as this may cause injury to the eye.

• Either nasolacrimal occlusion or gently closing the eyelid(s) after administration is recommended. This may reduce the systemic absorption of medicinal products administered via ocular route and result in a decrease in systemic adverse reactions.

• If more than one topical ophthalmic medicinal products is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

TOBRADEX® ophthalmic ointment
Posology
Apply a small amount (approximately 1cm of the ointment), into the conjunctival sac(s) up to 3 or 4 times daily.
TOBRADEX® ophthalmic ointment may be used at bedtime in conjunction with TOBRADEX ophthalmic suspension used during the day.
Not more than 20 ml or 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Pediatric patients
The safety and efficacy of TOBRADEX® ophthalmic ointment in children have not been established.

Hepatic or renal impairment
The safety and efficacy of TOBRADEX® ophthalmic ointment in patients with hepatic or renal impairment have not been established.

Method of administration

• For ocular use only.

• To prevent contamination of the tube tip and ointment, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the tube tip. Keep the tube tightly closed when not in use.

• Do not let the tip of the tube touch your eye.

• Gently closing the eyelid and nasolacrimal occlusion after instillation is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic side effects.

• In case of concomitant therapy with other topical ocular medicinal products, an interval of 5 minutes should be allowed between successive applications. Eye ointments should be administered last.

4.3 CONTRAINDICATIONS

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Herpes simplex keratitis.

• Vaccinia, varicella, and other viral infection of cornea or conjunctiva.

• Mycobacterial ocular infections.

• Fungal diseases of ocular structures or untreated parasitic eye infections.

• The use of TOBRADEX® is always contraindicated after uncomplicated removal of a foreign body.