Relestat

/ AbbVie

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.
Older people: Relestat has not been studied in older 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 older people 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. There are limited data on the safety in children aged 3-12 years.
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 medicinal products should be administered at least 10 minutes apart.

Treatment of the symptoms of seasonal allergic conjunctivitis.

Hypersensitivity to the active substance or to any of the excipients.

Relestat is for topical ophthalmic use only and not for injection or oral use.
Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Benzalkonium chloride may be absorbed by and discolour soft contact lenses and therefore patients should be instructed to wait until 10-15 minutes after instillation of Relestat before inserting contact lenses. Relestat should not be administered while wearing contact lenses.

In clinical studies, the overall incidence of adverse drug reactions following Relestat was less than 10%. No serious adverse reactions occurred. Most were ocular and mild. The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.
See prescribing information for full details.

No interaction studies have been performed.
No drug-drug interactions are anticipated in humans since systemic concentrations of epinastine are extremely low following ocular dosing. In addition, epinastine is mainly excreted unchanged in humans indicating a low level of metabolism.

Pregnancy: Data on a limited number (11) of exposed pregnancies indicate no adverse effects of epinastine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological
data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
Breast-feeding: Epinastine is excreted in the breast milk of rats, but it is not known if epinastine is excreted in human milk. Due to the lack of experience, caution should be exercised when prescribing to breast-feeding women.

After instillation of 0.3% epinastine hydrochloride eye drops 3 times daily (corresponds to 9 times the recommended daily dose) reversible miosis, without influence on visual acuity or other ocular parameters, was observed.
The 5 ml bottle of Relestat contains 2.5 mg of epinastine hydrochloride. A tablet formulation is marketed at a once daily dose of up to 20 mg epinastine hydrochloride, as such, intoxication after oral ingestion of the ophthalmic formulation is not expected even if the whole content of the bottle is swallowed.
No case of overdose has been reported.