Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL
Bepotastine Besilate Ophthalmic Solution 1.5% · SOLUTION/ DROPS · Alembic Pharmaceuticals Inc.
Bepotastine Besilate Ophthalmic Solution 1.5% is a solution/ drops containing bepotastine besilate ophthalmic solution 1.5% at 15 mg/mL, taken ophthalmic. Manufactured by Alembic Pharmaceuticals Inc..
Key Facts
- Brand Name
- Bepotastine Besilate Ophthalmic Solution 1.5%
- Generic Name
- Bepotastine Besilate Ophthalmic Solution 1.5%
- NDC Code (Product)
62332-598- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 15 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA214588
- Marketing Start
- 04/05/2023
Recall History
No Recall HistoryFull Prescribing Information
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.
Dosage & Administration
2 DOSAGE & 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.
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.
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 …
Frequently Asked Questions
What is Bepotastine Besilate Ophthalmic Solution 1.5% used for?
Bepotastine Besilate Ophthalmic Solution 1.5% contains Bepotastine Besilate Ophthalmic Solution 1.5%. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Bepotastine Besilate Ophthalmic Solution 1.5% a controlled substance?
Bepotastine Besilate Ophthalmic Solution 1.5% is not classified as a controlled substance by the DEA.
What is the generic name for Bepotastine Besilate Ophthalmic Solution 1.5%?
The generic name for Bepotastine Besilate Ophthalmic Solution 1.5% is Bepotastine Besilate Ophthalmic Solution 1.5%. There are no other listed brand versions of Bepotastine Besilate Ophthalmic Solution 1.5%.
What is the NDC code for Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL?
The NDC (National Drug Code) for Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL is 62332-598, listed by Alembic Pharmaceuticals Inc..
Other Bepotastine Besilate Ophthalmic Solution 1.5% Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)