Bepotastine Besilate
Generic: BEPOTASTINE BESILATE
Basic Information
Manufacturer
Somerset Therapeutics, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
cd6a061d-8ad7-4ad1-b039-1e3aa3435d32
Indications & Usage
1 INDICATIONS AND USAGE 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.
Bepotastine besilate ophthalmic solution is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Bepotastine besilate ophthalmic solution is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Adverse Reactions
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 Somerset Therapeutics, LLC at 1-800-417-9175 or the 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 clinical practice.
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation.
Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
6.2 Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of bepotastine besilate ophthalmic solution.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat.
Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or the 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 clinical practice.
The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation.
Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.
6.2 Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of bepotastine besilate ophthalmic solution.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat.