Bepotastine Besilate Ophthalmic Solution 1.5%
Generic: BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5%
Basic Information
Manufacturer
Alembic Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
f68306a9-80ec-4bc5-8c00-1e1328f21e36
Indications & Usage
1 INDICATIONS & USAGE Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
Bepotastine besilate ophthalmic solution is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Bepotastine besilate ophthalmic solution is a histamine H1 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 to 5% of subjects were eye irritation, headache, and nasopharyngitis.
( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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 to 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 to 5% of subjects were eye irritation, headache, and nasopharyngitis.
( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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 to 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.