Bepotastine Besilate Ophthalmic Solution 1.5%
Generic Name: bepotastine besilate ophthalmic solution 1.5%
Brand Names:
Bepotastine Besilate Ophthalmic Solution 1.5%
11 DESCRIPTION Bepotastine besilate ophthalmic solution 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of bepotastine besilate ophthalmic solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is: Bepotastine besilate is white or pale yellowish crystalline powder.
Overview
11 DESCRIPTION Bepotastine besilate ophthalmic solution 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of bepotastine besilate ophthalmic solution contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is: Bepotastine besilate is white or pale yellowish crystalline powder.
Uses
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
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.
Side Effects
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.
Warnings
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. Bepotastine besilate ophthalmic solution should not be instilled while wearing contact lenses. 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [ see Data ].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Bepotastine besilate ophthalmic solution 1.5% is supplied in a white low density polyethylene (LDPE) bottle with a white LDPE nozzle and a white high density polyethylene (HDPE) cap in the following size: 10 mL (NDC 46708-598-10) 5 mL (NDC 46708-598-05) STORAGE Store at 15°C to 25°C (59°F to 77°F).
Frequently Asked Questions
What is Bepotastine Besilate Ophthalmic Solution 1.5% used for?▼
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.
What are the side effects of Bepotastine Besilate Ophthalmic Solution 1.5%?▼
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.
Can I take Bepotastine Besilate Ophthalmic Solution 1.5% during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [ see Data ].
What are the important warnings for Bepotastine Besilate Ophthalmic Solution 1.5%?▼
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. Bepotastine besilate ophthalmic solution should not be instilled while wearing contact lenses. 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.