Alcafta 0.0025

INDICATIONS

Alcaftadine eye drops is indicated for the prevention of itching associated with allergic conjunctivitis. Alcaftadine ophthalmic solution is an H1 receptor antagonist, in a sterile ophthalmic solution for topical ophthalmic use.

PHARMACOLOGY

This eye drops is a sterile topical ophthalmic solution containing Alcaftadine. Alcaftadine is an histamine receptor antagonist and inhibitor of the release of histamine from mast cell. It is also a potent histamine H2 and H4 receptor antagonist that has demonstrated anti-inflammatory property. In doing so, antihistaminic effect provides relief from itching associated with early phase of ocular allergic response, whereas mast cell stabilization inhibits the release of mediators such as cytokines and lipid mediators that play a role in late-phase response of allergic conjunctivitis.

DOSAGE & ADMINISTRATION

Adults and children 2 years and over: Instill one drop in each eye once daily.

SIDE EFFECTS

The most frequent ocular reactions are eye irritation, burning or/and stinging upon instillation, eye redness and eye pruritus, nasopharyngitis and headache.

PREGNANCY & LACTATION

Pregnancy category B. There are however, no adequate and well controlled studies in pregnant women, thus this drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Caution should be exercised while administered to a nursing woman.

PRECAUTIONS & WARNINGS

To minimize eye injury and contamination of the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Patients should be advised not to wear a contact lens if their eye is red. This preparation should not be used to treat contact lens related irritation and should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation this preparation. Lenses may be reinserted after 10 minutes following administration. If more than 1 topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

USE IN SPECIAL POPULATIONS

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.Geriatric Use: No overall differences in safety or effectiveness were observed between elderly and younger subjects.

THERAPEUTIC CLASS

Ophthalmic Anti-allergic preparations

STORAGE CONDITIONS

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.