Indications
LOTEMAX ® SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. LOTEMAX ® SM is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )
Contraindications
LOTEMAX ® SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures. LOTEMAX ® SM, as with other ophthalmic corticosteroids, 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.
( 4 )
Warnings and precautions
Intraocular pressure (IOP) increase - 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. () Cataracts - Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed healing – The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. 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 such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. ( 5.3 ) Bacterial infections – Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.
In acute purulent conditions, steroids may mask infection or enhance existing infection. ( 5.4 ) Viral infections – Employment of a 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 may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.5 ) Fungal infections – Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application.
At a glance
- Brand name
- Lotemax SM
- Active substance
- loteprednol etabonate
- Route
- Eye
- Dosage form
- Gel
- Applicant
- Bausch and Lomb Inc
- Status
- Prescription
- FDA approval
- 22 Feb 2019
- Application
- NDA208219-001
- RxCUI
- 52177



