Nedocromil sodium is represented by the following structural formula:

Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.

Alocril (Nedocromil sodium drops)

®

Alocril (Nedocromil sodium drops)

®

Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.

Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in , mouse lymphoma forward mutation and mouse micronucleus assays.

Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).

The most frequently reported adverse experience was headache (~40%).

Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10- 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.

Some of these events were similar to the underlying ocular disease being studied.

The recommended dosage is one or two drops in each eye twice a day. ophthalmic solution should be used at regular intervals.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

5 mL in 10 mL bottle 0023-8842-05

It is important to use ophthalmic solution regularly, as directed by your physician.

© 2008 Allergan, Inc.Irvine, CA 92612, USA® marks owned by Allergan, Inc.U.S. Patent RE 38,628

71761US11X

ALLERGAN

NDC 0023-8842-05

(nedocromil sodium ophthalmic solution) 2%

STERILE

(nedocromil sodium

ophthalmic solution) 2%

For topical application in the eye

ALLERGAN