BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5%
(description)
| These highlights do not include all the information needed to use BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% safely and effectively. See full prescribing information for BEPREVE™. BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% Initial U.S. Approval: 2009 DESCRIPTION BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of BEPREVE™ contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. |
Clinical pharmacology
| CLINICAL PHARMACOLOGY Mechanism of Action Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells. |
Indications and usage
| INDICATIONS AND USAGE
BEPREVE™ is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. |
Precautions
| WARNINGS AND PRECAUTIONS
To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. Remove contact lenses prior to instillation of BEPREVE™. |
Adverse reactions
| ADVERSE REACTIONS
The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. To report SUSPECTED ADVERSE REACTIONS, contact ISTA Pharmaceuticals, Inc. at 1-877-788-2020, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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