FDA
Cromolyn Sodium
The FDA lists this product in 22 strengths and forms.
Indications
Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
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.
Pregnancy and breastfeeding
Pregnancy
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.
Composition
- Active ingredients
- CROMOLYN SODIUM 4%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
At a glance
- Brand name
- Cromolyn Sodium
- Route
- Eye
- Dosage form
- Solution/drops
- Applicant
- Sandoz
- Status
- Prescription
- FDA approval
- 16 Jun 1999
- Application
- ANDA075282-001