Cromolyn Drug Information

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

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%.

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.

Pediatric Use Safety and effectiveness in children below the age of 4 years have not been established.

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.