Overview
11 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.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells. 12.3 Pharmacokinetics Absorption: The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four times daily (QID) for 7 days, bepotastine plasma concentrations peaked at approximately 1 to 2 hours post-instillation. Maximum plasma concentrations for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively.
Indications
- 1 INDICATIONS AND USAGE BEPREVE ® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. BEPREVE is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Instill one drop of BEPREVE into the affected eye(s) twice a day. Remove contact lenses prior to instillation of BEPREVE. • Instill one drop into the affected eye(s) twice a day. ( 2 ) • Remove contact lenses prior to instillation of BEPREVE. ( 2 )
Contraindications
- 4 CONTRAINDICATIONS BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions ( 6.2 )] . Hypersensitivity to any component of this product. ( 4 )
Side Effects
- 6 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 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...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.