Inveltys
Generic: LOTEPREDNOL ETABONATE
Basic Information
Manufacturer
ALCON LABORATORIES, INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
2ec16df8-2e5c-4e06-8d28-21df76f27d72
Indications & Usage
1 INDICATIONS AND USAGE INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
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INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
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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 were eye pain (1%) and posterior capsular opacification (1%).
These reactions may have been the consequence of the surgical procedure.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc.
at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse drug reactions in the clinical trials with INVELTYS were eye pain and posterior capsular opacification, both reported in 1% of patients.
These reactions may have been the consequence of the surgical procedure.
The most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%).
These reactions may have been the consequence of the surgical procedure.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc.
at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most common adverse drug reactions in the clinical trials with INVELTYS were eye pain and posterior capsular opacification, both reported in 1% of patients.
These reactions may have been the consequence of the surgical procedure.