Skip to content
MedsAcross

Molecule

Epinastine

Also known as epinastine hydrochloride
Available on request
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Epinastine is an adrenergic receptor agonist indicated for the prevention of itching associated with allergic conjunctivitis. It is available as eye drops for ophthalmic use. MedsAcross supplies Epinastine 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
Adrenergic Receptor Agonist, Histamine-1 Receptor Inhibitor, Adrenergic Agonists, Histamine H1 Receptor Antagonists, Decreased Histamine Release
US FDA first approval
16 October 2003
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
Identifiers
UNII GFM415S5XLRxCUI 236961CAS 108929-04-0Q27122286

Clinical information

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

Uses

Epinastine HCl ophthalmic solution is an H 1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

Source: US FDA prescribing information

How it works

Epinastine is a topically active, direct H 1 -receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H 1 -receptor and has affinity for the histamine H 2 -receptor. Epinastine also possesses affinity for the ɑ 1, ɑ 2 -, and 5-HT 2 -receptors.

Source: US FDA prescribing information

Dosing overview

The recommended dosage is one drop in each eye twice a day. Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

Source: US FDA prescribing information

Warnings and precautions

To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use. Epinastine HCl should not be used to treat contact lens-related irritation. Remove contact lenses prior to instillation of epinastine HCl.

Source: US FDA prescribing information

Side effects

The most common ocular adverse reactions (incidence occurring in approximately 1% to 10% of epinastine HCl-treated eyes were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most common non-ocular adverse reactions, occurring in 10% epinastine HCl-treated eyes, were infection (cold symptoms and upper respiratory infections).

Source: US FDA prescribing information

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

All presentations

1 presentations of Epinastine, sorted by availability.

MedicineManufacturerRegisterAvailability
Epinastine 0.5 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request

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 16 October 2003Drugs@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 Epinastine available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Epinastine and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Epinastine approved by the US FDA?

Yes. The US FDA first approved Epinastine on 16 October 2003, according to Drugs@FDA.

Does Epinastine need cold chain shipping?

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

References

  1. EPINASTINE HYDROCHLORIDE prescribing information (Somerset Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 22 March 2025

Request Epinastine for export supply

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