Important Safety Information | Prescribing Information







A Formulation Engineered to Deliver Dose Uniformity—
Every Drop, Every Time


The Formulation Features of LOTEMAX GEL





LOTEMAX GEL Delivers Consistent Concentration in Every Drop



*Digital simulation of drop demonstration; GEL and Suspension dispensed from conventional drop bottles.

DID YOU KNOW: Poor patient compliance has been observed with shaking of ocular drugs5

In one study, 63% of patients did not shake an ophthalmic suspension medication
despite a labeled direction to shake*
No shaking required with LOTEMAX GEL2

*This study reported patient compliance (n=100) with the use of ophthalmic corticosteroid suspensions in an analysis of the
concentration of corticosteroid delivered when the drug bottles are shaken a number of times or not at all. LOTEMAX GEL
was not used in this study.





Indication

LOTEMAX GEL (loteprednol etabonate ophthalmic gel) 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Important Safety Information

  • LOTEMAX GEL is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
  • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation.
  • Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation and occurrence of perforations in those with diseases causing corneal and scleral thinning. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, and where appropriate, fluorescein staining.
  • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infections.
  • Use of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
  • Patients should not wear contact lenses when using LOTEMAX GEL.
  • The most common ocular adverse drug reactions were anterior chamber inflammation (5%), eye pain (2%) and foreign body sensation (2%).

Please click here for full Prescribing Information about LOTEMAX GEL.

References: 1. Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013;30(10):907-923. 2. Coffey MJ, Decory HH, Lane SS. Development of non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop. Clin Ophthalmol. 2013;7:299-312. 3. LOTEMAX GEL [prescribing information]. Bausch & Lomb Incorporated. 4. LOTEMAX Suspension [prescribing information]. Bausch & Lomb Incorporated. 5. Apt L, Henrick A, Silverman LM. Patient compliance with use of topical ophthalmic corticosteroid suspensions. Am J Ophthalmol. 1979;87(2):210-214.

LGX.0072.USA.17