Bepotastine Besilate 15 mg/mL
Bepotastine Besilate · SOLUTION/ DROPS · Mylan Pharmaceuticals Inc.
Bepotastine Besilate is a solution/ drops containing bepotastine besilate at 15 mg/mL, taken ophthalmic. Manufactured by Mylan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Bepotastine Besilate
- Generic Name
- Bepotastine Besilate
- NDC Code (Product)
0378-7055- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 15 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA206220
- Marketing Start
- 05/28/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instill one drop of Bepotastine Besilate Ophthalmic Solution into the affected eye(s) twice a day. Remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution. Instill one drop into the affected eye(s) twice a day. ( 2 ) Remove contact lenses prior to instillation of Bepotastine Besilate Ophthalmic Solution. ( 2 )
Contraindications
4 CONTRAINDICATIONS Bepotastine Besilate Ophthalmic Solution 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 )
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 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 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 possibl…
Frequently Asked Questions
What is Bepotastine Besilate used for?
Bepotastine Besilate contains Bepotastine Besilate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Bepotastine Besilate a controlled substance?
Bepotastine Besilate is not classified as a controlled substance by the DEA.
What is the generic name for Bepotastine Besilate?
The generic name for Bepotastine Besilate is Bepotastine Besilate. There are 3 other brand versions of Bepotastine Besilate.
What is the NDC code for Bepotastine Besilate 15 mg/mL?
The NDC (National Drug Code) for Bepotastine Besilate 15 mg/mL is 0378-7055, listed by Mylan Pharmaceuticals Inc..