Crolom®

GoodRx

cromolyn 4.0% · ophthalmic solution

Allergy

Approved uses

Vernal keratoconjunctivitis, including vernal conjunctivitis and vernal keratitis

1 or 2 drops in each eye 4 to 6 times daily at regular intervals

FDA label, Dosage and Administration (regimen and expected time course). Trial data from Foster CS. Evaluation of topical cromolyn sodium in the treatment of vernal keratoconjunctivitis. Ophthalmology. 1988;95(2):194-201 (randomized controlled multicenter trial). Comparative data from Caldwell DR, Verin P, Hartwich-Young R, Meyer SM, Drake MM. Am J Ophthalmol. 1992;113(6):632-637 (doi 10.1016/s0002-9394(14)74786-5, randomized controlled multicenter trial).

OFF-LABELNot in the FDA label for this product

Seasonal allergic conjunctivitis

1 or 2 drops in each eye 4 to 6 times daily, the labeled regimen; seasonal trials of 4% cromoglycate dosed QID

Cochrane · class, short-term

Cochrane review of 30 randomized trials and 4344 participants concluded that topical antihistamines and mast cell stabilizers as a class, sodium cromoglycate among the drugs evaluated, reduce symptoms and signs of seasonal allergic conjunctivitis versus placebo in the short term, with no long term efficacy data and highly variable reporting quality. A comparative review of the seasonal trials notes that cromoglycate eye drops did not control breakthrough symptoms during peak pollen challenge.

Castillo M, Scott NW, Mustafa MZ, Mustafa MS, Azuara-Blanco A. Topical antihistamines and mast cell stabilisers for treating seasonal and perennial allergic conjunctivitis. Cochrane Database Syst Rev. 2015;2015(6):CD009566 (systematic review with meta-analysis). Peak-pollen breakthrough and the 4% QID seasonal regimen from Alexander M. Comparative therapeutic studies with Tilavist. Allergy. 1995;50(21 Suppl):23-29 (review) (doi 10.1111/j.1398-9995.1995.tb04253.x).

Contraindications

Hypersensitivity to cromolyn sodium or to any of the other ingredients in the formulation.

Available Forms

Ophthalmic solution, cromolyn sodium 40 mg/mL (4%), 10 mL opaque polyethylene bottle with controlled dropper tip

Mechanism of Action

Mast cell stabilizer: inhibits degranulation of sensitized mast cells and the release of histamine and slow reacting substance of anaphylaxis, the mediators of the type I allergic response. No intrinsic antihistamine, vasoconstrictor, or anti-inflammatory activity, so benefit is prophylactic and depends on dosing at regular intervals rather than on blocking mediators already released.

Warnings & Precautions

Delayed benefit: Effect depends on administration at regular intervals; days of dosing are usually needed before response, and up to six weeks in some patients.
Contact lens wear: Lenses should not be worn during treatment, or while signs and symptoms of vernal disease are present; preserved with benzalkonium chloride 0.01%.
Dosing frequency: The recommended frequency should not be exceeded.

Common Side Effects

Ocular: Transient stinging or burning on instillation, the most frequently reported reaction and the one confirmed by recurrence on readministration; infrequent conjunctival injection, watery eyes, itchy eyes, dryness around the eye, puffy eyes, eye irritation, and styes, which the label notes may not be drug related.
Systemic: Rare immediate hypersensitivity reactions including dyspnea, edema, and rash.

Pregnancy & Lactation

Pregnancy: Category B. No adequate and well controlled studies in pregnant women; subcutaneous and intravenous animal doses 35 to 205 times the maximum daily human dose on a mg/m2 basis produced no fetal malformation, and increased resorption and decreased fetal weight appeared only at parenteral doses high enough to produce maternal toxicity.

Lactation: Excretion in human milk is unknown; use caution in nursing women.

Pediatric Use

Safety and effectiveness below age 4 not established.