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4. CLINICAL FEATURES
4.1. Therapeutic indications
LOTEBRA is indicated in steroid responsive inflammatory ocular situations where a corticosteroid is indicated and a superficial ocular bacterial infection by susceptible bacteria is observed or there is a risk of bacterial ocular infection.
4.2. Posology and method of administration
Posology / application frequency and duration:
1-2 drops are applied to the conjunctival sac of the affected eye every 4-6 hours. For the first 24-48 hours, the dosage can be increased to one drop every 1-2 hours. The frequency of instillation should be reduced gradually, according to the improvement observed in clinical symptoms. Care should be taken not to stop the treatment early.
Method of Application:
It should be shaken well before use.
For ophthalmic use only. The initiation of the treatment and the repetition of the treatment after 14 days should be done by a physician after the patient is examined by magnification methods such as slit lamp microscopy and fluorescent staining under appropriate conditions.
If there is no improvement in signs and symptoms after 2 days, the patient should be re-evaluated.
To avoid contamination, the tip of the dropper should not touch any surface. In cases where pain, redness, itching or inflammation occurs or worsens, a doctor should be consulted.
Additional information on special populations:
Kidney / Liver failure:
There are no reports from this population regarding topical ophthalmic use. Pediatric population:
Safety and efficacy in pediatric patients has not been evaluated. No difference in safety and efficacy was observed between elderly and younger patients.
There are no reports from this population regarding topical ophthalmic use. No difference in safety and efficacy was observed between elderly and younger patients.
As with other steroid antiinfective ophthalmic combination drugs, LOTEBRA is contraindicated in most viral diseases associated with the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccine and varicella, mycobacterial infection of the eye, and fungal diseases of the ocular structures. LOTEBRA is contraindicated in people with known or suspected hypersensitivity to any of the components of this preparation and to other corticosteroids.
4.4. Special warnings and precautions for use
• It is not injected into the eye.
• Long-term use of corticosteroids can cause glaucoma and posterior subcapsular cataracts with optic nerve damage, visual acuity and visual field defects. Steroids should be used with caution in the presence of glaucoma.
• Some patients may develop sensitivity to topically applied aminoglycosides. If a sensitization reaction is observed, the drug should be discontinued.
• Long-term use of cortico steroids may suppress host response and increase the risk of secondary ocular infections. It is known that tears occur with the use of topical steroids in diseases that cause thinning of the cornea or sclera. In acute purulent cases in the eye, steroids may mask the infection or increase the existing infection.
• Ocular steroid use can prolong the course of the disease and exacerbate the severity of various viral infections in the eye (including herpes simplex). Care should be taken when using a corticosteroid-containing drug in the treatment of patients with a history of herpes simplex.
• The use of steroids after cataract surgery can delay healing and increase the incidence of blep formation.
• For ophthalmic use only.
• The initiation of the treatment and the repetition of the treatment after 14 days should be done by a physician after the patient is examined by magnification methods such as slit lamp microscopy and fluorescent dyeing under appropriate conditions,
• If there is no improvement in signs and symptoms after 2 days, the patient should be re-evaluated.
• If the product has been used for 10 days or more, intraocular pressure should be monitored, even in children and patients who are difficult to cooperate, although it is difficult.
• In long-term applications of local steroids, fungal infections may develop in the cornea.
Fungal invasion should be considered in persistent corneal ulcerations where a steroid has been or continues to be used. Mushroom culture should be done under appropriate conditions.
• As with other antibiotic preparations, prolonged use of antibiotics can result in the growth of some non-susceptible organisms, including fungi. In case of development of super infection, appropriate treatment should be initiated.
• Cross-sensitivity may develop to other antibiotics from the aminoglycoside group; In cases where hypersensitivity to this product is observed, use of the drug should be discontinued and appropriate precautions should be taken.
• During the use of LOTEBRA, the tip of the dropper should not be placed on any surface to avoid contamination.