TOBRAMYCIN

Posology Adults One drop instilled into the conjunctival sac(s) every 4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the patient is awake. Dosing should continue for 14 days not to exceed a maximum of 24 days.

Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Use in the Elderly Clinical studies have indicated dosage modifications are not required for use in the elderly.

Paediatric population Tobramycin/dexamethasone may be used in children 2 years of age and older at the same dose as in adults. 1. The safety and efficacy in children younger than 2 years of age have not been established, and no data is available.

Shake the bottle well before use. Method of administration Ocular use. Shake the bottle well before use. To prevent contamination of the dropper tip and suspension, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle.

Keep the bottle tightly closed when not in use. In case of concomitant therapy with other topical ophthalmic medicinal products, an interval of 5 minutes should be allowed between successive applications. Eye ointments should be administered last.

During clinical studies involving over 1600 patients, tobramycin/dexamethasone was administered up to 6 times per day. No serious adverse reactions, either ocular or systemic, were described, related to the active substances or any components of the product.

The undesirable effects observed most often during treatment with tobramycin/dexamethasone were eye pain, intraocular pressure increased, eye irritation (burning sensation after instillation) and eye pruritus occurring in less than 1% of patients.

000), not know (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. 4) Nervous system disorders Common Headache Eye disorders Common Eye irritation,* Ocular hyperaemia,* Erythema of eyelid, Abnormal sensation in eye* Respiratory, thoracic, and mediastinal disorders Common Post nasal drip The following adverse reactions have been observed following use with Tobramycin ophthalmic suspension: System organ classification Frequency Adverse reaction Eye disorders Common Ocular hyperaemia*, Eye pain* Uncommon Eye pruritus,* Ocular discomfort,* Eye allergy, Eyelid oedema,* Conjunctivitis, * Glare, Increased lacrimation,* Keratitis* *These events were also observed with tobramycin/dexamethasone postmarketing.

Prolonged use of topical ophthalmic corticosteroids may result in increased intraocular pressure with damage to the optical nerve, reduced visual acuity and visual field defects, posterior subcapsular cataract formation and delayed wound healing.

4). The development of secondary infection has occurred after the use of combinations containing corticosteroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long term applications of steroids.

4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care professionals are asked to report any suspected adverse reactions via their national reporting system Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This product is for topical use only and not for injection or oral use. , longer than the maximum duration used in clinical trials [24 days]) may result in ocular hypertension/glaucoma with resultant damage to the optic nerve and reduced visual acuity and visual fields defects and may also result in posterior subcapsular cataract formation.

It is advisable that the intraocular pressure be checked frequently. This is especially important in paediatric patients receiving dexamethasone-containing products, as the risk of steroid-induced ocular hypertension may be greater in children below 6 years of age and may occur earlier than a steroid response in adults.

The frequency and duration of treatment should be carefully considered, and the intraocular pressure should be monitored from the outset of treatment, recognizing the risk for earlier and greater steroid-induced intraocular pressure increases in the paediatric patients.

g. diabetes). Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Caution should be exercised when prescribing this medicine to patients with known or suspected neuromuscular disorders such as myasthenia gravis or Parkinson's disease. Aminoglycosides may aggravate muscle weakness because of their potential effect on neuromuscular function.

Cushing’s syndrome and/or adrenal suppression associated with systemic absorption of ocular dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat).

In these cases, treatment should be progressively discontinued. Prolonged use may also result in secondary ocular infections due to suppression of host response. Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral or fungal infection and mask the clinical signs of infection.

Sensitivity to topically applied aminoglycosides may occur in some patients. If hypersensitivity develops during use of this medicine, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Caution is advised when used concomitantly. Fungal infection should be suspected in patients with persistent corneal ulceration.

If fungal infection occurs, corticosteroids therapy should be discontinued. Prolonged use of antibiotics such as tobramycin may result in overgrowth of non- susceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5). In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with topical corticosteroids.

The preservative in this product, benzalkonium chloride, has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.

Patients should be monitored in case of prolonged use. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Contact lens wear is not recommended during treatment of an ocular infection or inflammation.

If patients are allowed to wear contact lenses, they must be instructed to remove lenses prior to application and wait at least 15 minutes before reinsertion.

Paediatric population:

From the limited data available, there is no difference in the adverse event profile of benzalkonium chloride in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye.

Irritation may have an effect on treatment adherence in children.

1. • Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. • Mycobacterial infections of the eye caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium.

• Fungal diseases of ocular structures • Untreated purulent infection of the eye.