Cromolyn Sodium

INDICATIONS AND USAGE Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

DOSAGE AND ADMINISTRATION The dose is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed. Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly with Cromolyn Sodium Ophthalmic Solution USP, 4%.

CONTRAINDICATIONS Cromolyn Sodium Ophthalmic Solution USP, 4% is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

ADVERSE REACTIONS The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation. The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributable to the drug: Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes. Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and rash.

DESCRIPTION Cromolyn Sodium Ophthalmic Solution USP, 4% is a clear, colorless, sterile solution intended for topical ophthalmic use. Cromolyn sodium is represented by the following structural formula: Chemical Name: Disodium 5-5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate] Pharmacologic Category: Mast cell stabilizer. EACH mL CONTAINS: Active: cromolyn sodium 40 mg (4%); Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1% and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.0). chemicalstructure

HOW SUPPLIED Cromolyn Sodium Ophthalmic Solution USP, 4% is supplied in a white, opaque, plastic ophthalmic dispenser in the following sizes: 10 mL NDC 71205-230-10 Storage: Store between 15° - 30°C (59°- 86°F). Protect from light-store in original carton. Keep tightly closed and out of the reach of children. Rx Only