Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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.
5 WARNINGS AND PRECAUTIONS Contamination of Solution: Do not touch the dropper tip to any surface.
Keep bottle tightly closed when not in use.
( 5.1 ) Contact Lens Wear: Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation.
( 5.2 ) 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use.
5.2 Contact Lens Wear Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation.
Like all medications, Bepotastine Besilate Ophthalmic Solution 1.5% can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: