Lotemax

Lotemax Adverse Reactions

loteprednol

Manufacturer:

Bausch & Lomb

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Adverse Reactions
Reactions associated with ophthalmic steroids include elevated intraocular pressure which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens eg, herpes simplex and the perforation of the globe where there is thinning of the cornea or sclera.
Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection and photophobia. Other ocular adverse reactions occurring in <5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae and uveitis. Some of these events were similar to the underlying ocular disease being studied.
Non-ocular adverse reactions occurred in <15% of patients. These include headache, rhinitis and pharyngitis.
In a summation of controlled, randomized studies of individuals treated for ≥28 days with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving prednisolone acetate 1% and 0.5% (3/583) among patients receiving placebo.
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