HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LOTEMAX® SM safely and effectively. See full prescribing informationfor LOTEMAX® SM.
LOTEMAX® SM(loteprednol etabonate ophthalmic gel)0.38%, fortopical ophthalmic use
Initial U.S. Approval: 1998
INDICATIONS AND USAGE
LOTEMAX® SM is a corticosteroid indicated for the treatment of postoperativeinflammation and pain following ocular surgery. (1)
DOSAGE AND ADMINISTRATION
Invert closed bottle and shake once to fill tip before instilling drops. (2)
Apply one drop of LOTEMAX® SM into the conjunctival sac of the affectedeye three times daily beginning the day after surgery and continuingthroughout the first 2 weeks of the post-operative period. (2)
DOSAGE FORMS AND STRENGTHS
LOTEMAX® SM is a sterile preserved ophthalmic gel containing 3.8 mg ofloteprednol etabonate per gram of gel. (3)
CONTRAINDICATIONS
LOTEMAX® SM, as with other ophthalmic corticosteroids, is contraindicatedin most viral diseases of the cornea and conjunctiva including epithelialherpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and alsoin mycobacterial infection of the eye and fungal diseases of ocular structures.(4)
WARNINGS AND PRECAUTIONS
Intraocular pressure (IOP) increase - Prolonged use of corticosteroidsmay result in glaucoma with damage to the optic nerve, defects in visualacuity and fields of vision. If this product is used for 10 days or longer,IOP should be monitored. (5.1)
Cataracts - Use of corticosteroids may result in posterior subcapsularcataract formation. (5.2)
Delayed healing – The use of steroids after cataract surgery may delayhealing and increase the incidence of bleb formation. In those diseasescausing thinning of the cornea or sclera, perforations have been knownto occur with the use of topical steroids. The initial prescription andrenewal of the medication order should be made by a physician onlyafter examination of the patient with the aid of magnification such as slitlamp biomicroscopy and, where appropriate, fluorescein staining. (5.3)
Bacterial infections – Prolonged use of corticosteroids may suppress thehost response and thus increase the hazard of secondary ocularinfections. In acute purulent conditions, steroids may mask infection orenhance existing infection. (5.4)
Viral infections – Employment of a corticosteroid medication in thetreatment of patients with a history of herpes simplex requires greatcaution. Use of ocular steroids may prolong the course and mayexacerbate the severity of many viral infections of the eye (includingherpes simplex). (5.5)
Fungal infections – Fungal infections of the cornea are particularlyprone to develop coincidentally with long-term local steroid application.
Fungus invasion must be considered in any persistent corneal ulcerationwhere a steroid has been used or is in use. (5.6)
ADVERSE REACTIONS
There were no treatment-emergent adverse drug reactions that occurred inmore than 1% of subjects in the three times daily group compared to vehicle.(6)
To report SUSPECTED ADVERSE REACTIONS, contact Bausch +Lomb, a division of Valeant Pharmaceuticals North America LLC, at1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 02/2019
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