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BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5%

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED

(DESCRIPTION) top of page

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: top of page

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  top of page

INDICATIONS AND USAGE

BEPREVE™ is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.

CONTRAINDICATIONS top of page

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PRECAUTIONS top of page

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.
BEPREVE™ should not be used to treat contact lens-related irritation.

Remove contact lenses prior to instillation of BEPREVE™.

ADVERSE REACTIONS top of page

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.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION

Instill one drop into the affected eye(s) twice a day (BID).

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

Solution containing bepotastine besilate, 1.5%.

REFERENCE

Package Insert data: 
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