Alcadin (Alcaftadine 0.25%)
Alcadin (Alcaftadine 0.25%)

AlcadinTM ophthalmic solution containing alcaftadine for topical administration to the eyes.

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Pharmacology/Description

Each ml contains: Active substance: Alcaftadine 0.25% (2.5 mg/ml) Preservative: Benzalkonium Chloride 0.05 mg. Alcaftadine is a potent histamine H1, H2 & H4 receptor antagonist with anti-inflammatory properties. The activation of H1 receptor causes itching & H4 receptor causes itching & inflammation. Histamine binding with H1 & H2 receptor causes redness and swelling. Alcaftadine also inhibit the release of histamine from mast cell through limit the entry of Ca++ across the membrane as a result prevent degranulation. Alcaftadine also stabilize tight junction protein (zonula occludin) of conjuctival epithelium that normally becomes disorganized following allergen exposure so that decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.

Indication

AlcadinTM eye drops indicated for the treatment of signs and symptoms (itchy, watery, red and swollen eyes and/or eyelids) of allergic conjunctivitis including vernal keratoconjunctivitis, vernal keratitis, blepharitis, blepharoconjunctivitis and giant papillary conjunctivitis.

Dosage And Administration

The recommended dose of AlcadinTM eye drops is 1 drop in the affected eye(s) once a day.

Contraindications

It is contraindicated in persons with a known hypersensitivity to any component of this product.

Precautions

A. Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. B. Contact Lens Use Remove contact lenses prior to instillation of AlcadinTM. Lenses may be reinserted after 10 minutes following administration of AlcadinTM.

Over Dosage

A. Ocular Adverse Reactions The most frequent ocular adverse reactions, occurring in <4% of alcaftadine eye drops treated eyes were eye irritation, burning and/or stinging upon instillation, eye redness and eye pruritus. B. Non-ocular Adverse Reactions The most frequent non-ocular adverse reactions, occurring in <3% of subjects with alcaftadine eye drops treated eyes, were nasopharyngitis, headache and influenza. Some of these events were similar to the underlying disease being studied.

Pharmaceutical Precautions

A. Pregnancy Pregnancy Category B. Reproduction studies performed in rats and rabbits revealed no evidence of impaired female reproduction or harm to the fetus due to alcaftadine.There are however, this drug should be used during pregnancy only if clearly needed. B. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when alcaftadine eye drops is administered to a nursing woman. C. Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established. D. Geriatric Use No overall differences in safety or effectiveness were observed between elderly and younger subjects. AlcadinTM should be stored at room temperature. Protect from light. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

Commercial Pack

AlcadinTM 0.25% is supplied in 5 ml plastic dropper bottle.