Epinastine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Epinastine

Active ingredient · 2 therapeutic classes

US FDAGB MHRA

Drug class: Other Antihistamines For Systemic Use
Availability: Prescription only
Routes: Ophthalmic
Markets covered: 2
Products on record: 2

R06AXOther Antihistamines For Systemic Use S01GXOther Antiallergics

Overview

Epinastine is an active pharmaceutical ingredient in the Other Antihistamines For Systemic Use group (R06AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	1	March 22, 2025
GB United Kingdom	MHRA	1	May 15, 2026

USUnited States· FDA

1 product

Uses

USOfficial regulatory label· revised March 22, 2025[1]

1 INDICATIONS AND USAGE 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.

How to take

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised May 15, 2026[2]

Treatment of the symptoms of seasonal allergic conjunctivitis.

How to take

GBOfficial regulatory label

Sources & citations

[1]FDA DailyMed · 0d4ee45c-e58f-4b… · revised March 22, 2025 [PDF]
[2]MHRA (UK) · PL410420075 · revised May 15, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

USOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

6 ADVERSE REACTIONS 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).
gov/medwatch. 1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The most frequently reported ocular adverse reactions occurring in approximately 1 to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 to 3% of patients.
Some of these reactions were similar to the underlying disease being studied. 2 Postmarketing Experience The following reactions have been identified during postmarketing use of epinastine HCl in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to epinastine HCl, or a combination of these factors, include: lacrimation increased.

USOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

5 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. 1 ) Epinastine HCl should not be used to treat contact lens-related irritation. 1 Contamination of Tip and Solution Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Bottle should be kept tightly closed when not in use. 2 Use with Contact Lenses Patients should be advised not to wear a contact lens if their eye is red.
Epinastine HCl ophthalmic solution should not be used to treat contact lens-related irritation. The preservative in epinastine HCl, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of epinastine HCl ophthalmic solution and may be reinserted after 10 minutes following its administration.
3 Topical Ophthalmic Use Only Epinastine HCl ophthalmic solution is for topical ophthalmic use only and not for injection or oral use.

This is not medical advice. Consult a qualified healthcare professional.

Posology The recommended dose for adults is one drop instilled in each affected eye twice daily, during the symptomatic period. There is no experience in clinical studies with the use of Relestat for more than 8 weeks. Elderly Relestat has not been studied in elderly people.
Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that there are no particular safety issues for elderly compared with adult patients. As such, no dosage adjustment is considered to be necessary.
Paediatric population The safety and efficacy in children ≥ 12 years has been established in clinical trials. Relestat may be used in adolescents (12 years of age and older) at the same dosage as in adults. The safety and efficacy of Relestat in children aged less than 3 years have not been established.
No data are available. 1. Patients with hepatic impairment Relestat has not been studied in patients with hepatic impairment. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that the incidence of adverse reactions was higher in this group compared with adult patients without hepatic impairment.
The daily dose of a 10 mg epinastine hydrochloride tablet is more than 100-fold higher than the daily dose following Relestat. In addition, the metabolism of epinastine in humans is minimal (<10%). Therefore, no dosage adjustment is considered to be necessary.
Patients with renal impairment Relestat has not been studied in patients with renal impairment. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicate that there are no particular safety issues for patients with renal impairment.
As such, no dosage adjustment is considered to be necessary. Method of administration Relestat is for topical ophthalmic use only. To avoid contamination of the eye or eye drops, do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic medicinal product is being used, the different medicinal products should be administered at least 10 minutes apart.