Epinast

Epinast

epinastine

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Epinastine hydrochloride.
Description
Each mL contains epinastine hydrochloride 0.5 mg.
It also contains benzalkonium chloride solution 0.02% as preservative and polyvinyl alcohol 1% as vehicle.
Action
Pharmacology: Epinastine is a topically active antihistamine that antagonizes both histamine H1 and H2 receptors. Moreover, it has mast cell stabilizing activity and prevents the release of inflammatory mediators from blood vessel.
Epinastine does not penetrate the blood-brain barrier and therefore is not expected to induce adverse effects of the central nervous system.
Indications/Uses
Treatment of signs and symptoms of allergic conditions of the anterior segment of the eye.
Dosage/Direction for Use
Instill 1 drop in the affected eye(s) twice daily.
Contraindications
Hypersensitivity to epinastine or to any of the components of Epinast.
Special Precautions
For ophthalmic use only.
Patients should be advised not to wear contact lenses if their eye is red.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Epinastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether epinastine is excreted in human milk. Caution should be exercised when epinastine is administered to a nursing mother.
Use in children: Safety and effectiveness in children below the age of 3 years have not been established.
Use in the elderly: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
Use In Pregnancy & Lactation
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Epinastine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether epinastine is excreted in human milk. Caution should be exercised when epinastine is administered to a nursing mother.
Adverse Reactions
Most frequently reported adverse effects are mild burning sensation, folliculosis, hyperemia, pruritus, cold symptoms and upper respiratory infections.
Storage
Store below 30°C. Protect from light.
Not to be used 1 month after opening.
ATC Classification
S01GX10 - epinastine ; Belongs to the class of other ophthalmologic antiallergics.
Presentation/Packing
Ophth soln 0.5 mg/mL x 5 mL x 1's. 10 mL x 1's.
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