Important Safety Information | Prescribing Information







Established Efficacy In Post-Cataract Inflammation and Pain Control


More patients achieved complete resolution of anterior chamber
cells with LOTEMAX GEL vs vehicle at Days 8 and 151-4





  LOTEMAX GEL vs vehicle

  • Day 8: 31% (126/409) vs 15% (61/404); P<0.001
  • Day 15: 53% (218/409) vs 26% (105/404); P<0.001

*Pivotal trials: Two, independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled, pooled studies in 813 patients to examine the safety and efficacy of LOTEMAX GEL in the treatment of postoperative inflammation and pain following cataract surgery.

†Primary efficacy endpoint on Day 8; secondary endpoint on Day 15.


Please see Important Safety Information below.









More patients treated with LOTEMAX GEL
were pain free at Days 8 and Day 15 vs vehicle1-4





  LOTEMAX GEL vs vehicle

  • Day 8: 75% (304/409) vs 44% (177/404); P<0.001
  • Day 15: 77% (314/409) vs 41% (166/404); P<0.001

*Pivotal trials: Two, independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled, pooled studies in 813 patients to examine the safety and efficacy of LOTEMAX GEL in the treatment of postoperative inflammation and pain following cataract surgery.

†Primary efficacy endpoint on Day 8; secondary endpoint on Day 15.


Please see Important Safety Information below.










A Tolerability Profile You Expect From Loteprednol Etabonate1

 

Low incidence of IOP elevations vs vehicle

Risk of significant IOP elevations (≥ 10mm Hg) was similar to that of vehicle: 0.49% (2/409)
for LOTEMAX GEL vs 0.25% (1/404) for vehicle
If this product is used for 10 days or longer, IOP should be monitored2

Pivotal trials: Two, independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled, pooled
studies in 813 patients to examine the safety and efficacy of LOTEMAX GEL in the treatment of postoperative
inflammation and pain following cataract surgery.

 





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. LOTEMAX GEL [prescribing information]. Bausch & Lomb Incorporated. 3. Rajpal RK, Roel L, Siou-Mermet R, Erb T. Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2013;39(2):158-167. 4. Fong R, Leitritz M, Siou-Mermet R, Erb T. Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial. Clin Ophthalmol. 2012; 6:1113-1124.

LGX.0072.USA.17