RELESTAT 0.5/MG EYE DROPS 5ML

Indications

Approved Uses

Treatment of itching associated with allergic conjunctivitis (seasonal/perennial).

Dosage & Administration

Dosing by Condition

Allergic conjunctivitis/ocular itching (adults, teenagers, and children 2 years of age and older): instill 1 drop in each affected eye twice daily.

Initial Dose

One drop in each affected eye twice daily.

Maintenance Dose

1 drop in each affected eye twice daily

Maximum Dose

1 drop in each affected eye twice daily

Children's Dosage

Children ≥2 years: 1 drop in each affected eye twice daily (same as adult dose). Safety & efficacy not established for children under 2 years

Dose Adjustment Notes

No dosage adjustment is generally required in renal or hepatic impairment for ophthalmic epinastine due to minimal systemic exposure.

How to Take

Wash hands; remove contact lenses; tilt head back and pull down lower lid; instill 1 drop into the conjunctival sac of the affected eye(s); avoid touching the dropper tip to eye/skin/surfaces; close the eye gently and perform nasolacrimal occlusion (press inner canthus) for about 1-2 minutes; if using other eye meds, separate by at least 5-10 minutes.

Side Effects

Common Side Effects

Common: transient burning/stinging, eye irritation, eye redness (hyperemia), eye itching (pruritus), increased tearing; non-ocular: headache and upper-respiratory symptoms such as rhinitis/pharyngitis/sinusitis (URTI-like symptoms).

Side Effect Frequency

Common (≥1% to <10%): burning/stinging, ocular irritation, conjunctival hyperemia, pruritus, folliculosis; Uncommon (<1%): headache and other systemic/respiratory symptoms (e.g., rhinitis/URTI-like symptoms) and hypersensitivity reactions.

Safety & Warnings

Warnings & Precautions

For ophthalmic use only (not oral/injectable); avoid contaminating the dropper tip; do not use to treat contact lens-related irritation; remove contact lenses before use and reinsert after ~10-15 minutes (especially if preservative such as benzalkonium chloride is present)

Age Restriction

Approved for children ≥2 years; not recommended/approved for <2 years

Drug Interactions

Drug Interactions

No clinically significant drug interactions are expected with ophthalmic use; if using other eye drops, separate administrations by 5-10 minutes

Interaction Severity

No clinically significant drug interactions are expected with ophthalmic epinastine.

Food Interaction

No restriction

Special Populations

Breastfeeding

Excretion in milk unknown; use with caution

Children

Children ≥2 years: 1 drop in each affected eye twice daily (same as adult dose). Safety & efficacy not established for children under 2 years

Elderly

Standard adult dosing. No overall differences in safety or effectiveness have been observed.

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep bottle tightly closed when not in use. Do not use if solution changes color or becomes cloudy. Discard 28 days after first opening.

Stopping the Medicine

May be stopped when symptoms resolve or allergen exposure ends; no taper is required (use as needed/for the symptomatic period per prescriber)

Patient Counseling

Use 1 drop in each affected eye twice daily; remove contact lenses before use and reinsert after at least 10-15 minutes; avoid touching the dropper tip; if using other eye drops, separate by 5-10 minutes; temporary blurred vision/stinging may occur-avoid driving until vision clears; store below 25°C; discard the bottle per local labeling after opening (commonly 28 days unless the product leaflet states otherwise).

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Dual-acting agent: selective H1-antihistamine with mast-cell stabilizing activity, inhibiting histamine and other mediator release to reduce allergic ocular symptoms.

Onset of Action

Within about 3-5 minutes.

Duration of Effect

Approximately 8-12 hours.

Half-Life

Approximately 12 hours (systemic terminal half-life; based on oral/systemic PK, with very low systemic exposure after ophthalmic use).

Bioavailability

Low systemic exposure after ophthalmic administration (very low plasma concentrations).

Product Information

Available Dosage Forms

Eye drops, solution.

Composition per Dose

Each mL: 0.5 mg epinastine hydrochloride (0.05%); each 5 mL bottle contains 2.5 mg epinastine hydrochloride

Generic Availability

Yes

OTC Alternatives

OTC alternatives may exist depending on country (e.g., ketotifen 0.025% ophthalmic solution for allergic conjunctivitis/itching).

Target Organ

Eye

Preservative Free

No

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