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Molecule

Bepotastine

Also known as bepotastine besilate, bepotastine besylate
Available on request
Presentations
3
Brands
1
Manufacturers
1
Available from stock
0

Bepotastine is a histamine-1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. It is available as eye drops and ophthalmic solution. MedsAcross supplies Bepotastine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Histamine-1 Receptor Antagonist
US FDA first approval
8 September 2009
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops, Ophthalmic solution
Identifiers
UNII HYD2U48IASRxCUI 863035CAS 125602-71-3Q4890915

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.

Source: US FDA prescribing information

Dosing overview

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.

Source: US FDA prescribing information

Contraindications

Bepotastine Besilate Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients. Hypersensitivity to any component of this product.

Source: US FDA prescribing information

Warnings and precautions

Contamination of Solution: Do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. Contact Lens Wear: Bepotastine Besilate Ophthalmic Solution should not be used to treat contact lens-related irritation.

Source: US FDA prescribing information

Side effects

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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

3 presentations of Bepotastine, sorted by availability.

MedicineManufacturerRegisterAvailability
Bepotastine 15 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Bepreve 15 mg/mL eye dropsOphthalmicBausch & LombUS FDAAvailable on request
Bepotastine 15 mg/mL ophthalmic solutionOphthalmicGeneric name—US FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 8 September 2009Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Bepotastine available for export from India?

Yes, on request. MedsAcross lists 3 presentations of Bepotastine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Bepotastine have?

The catalogue lists 1 brand names for Bepotastine, including Bepreve.

Is Bepotastine approved by the US FDA?

Yes. The US FDA first approved Bepotastine on 8 September 2009, according to Drugs@FDA.

Does Bepotastine need cold chain shipping?

No listed presentation of Bepotastine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Bepotastine Besilate prescribing information (Bausch & Lomb Americas). U.S. National Library of Medicine, DailyMed. Retrieved 20 August 2024

Request Bepotastine for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.