Loteprednol Etabonate
Generic: LOTEPREDNOL ETABONATE
Basic Information
Manufacturer
ARMAS PHARMACEUTICALS INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
091a068f-f9b0-b02b-e063-6294a90a95e6
Indications & Usage
1 INDICATIONS AND USAGE Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
( 1 )
Loteprednol etabonate ophthalmic gel is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
The most common adverse drug reactions reported in the clinical trials (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation.
The most common adverse drug reactions (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The most common adverse drug reactions reported in the clinical trials (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation.
The most common adverse drug reactions (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.