Introduction

Mast-cell stabilizer.

Uses for Cromolyn (EENT)

Allergic Rhinitis

Self-medication for the symptomatic prevention and treatment of seasonal or perennial allergic rhinitis. Provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and postnasal drip.

Should not use as self-medication for the treatment of sinus infection^{† [off-label]}, asthma^{† [off-label]}, or cold symptoms^{† [off-label]}.

Allergic Ocular Disorders

Symptomatic treatment of certain allergic ocular disorders (e.g., vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis).

Has been used for the treatment of giant papillary conjunctivitis^{† [off-label]}.

Cromolyn (EENT) Dosage and Administration

General

• For patients with seasonal or perennial rhinitis, continue therapy throughout the period of allergen exposure (e.g., until the pollen season is over or contact with allergen has ceased).

• If exposure to allergens cannot be predicted, initiate therapy at the first sign of nasal symptoms.

• Should not use other ocular agents with ophthalmic solution unless directed by a clinician. However, may use corticosteroids with ophthalmic solution.

Administration

Administer intranasally or topically to the eye.

Administer at regular intervals.

Intranasal Administration

Parents or care providers must supervise use by young children. In very young children, an adult should administer nasal solution. Use care when inserting the nozzle into the nose to avoid injury.

Prior to administration, clear nasal passages by blowing the nose; administration of a topical nasal decongestant may be necessary. Inhale through the nose during administration.

For maximum therapeutic effect, initiate therapy before (e.g., ≤1–2 weeks before) and continue at regular intervals during the period of allergen exposure.

Ophthalmic Administration

Applied topically to the eye as an ophthalmic solution just inside the lower eyelid; patients should avoid applying the solution directly on the cornea.

To avoid contamination of dropper tip and solution, avoid touching the tip of the dispensing dropper or container to the eye, fingers, or any other surface.

Dosage

Available as cromolyn sodium.

Nasal pump delivers 5.2 mg of cromolyn sodium per metered spray.

One drop of cromolyn sodium ophthalmic solution contains approximately 1.6 mg of cromolyn sodium.

Pediatric Patients

Allergic Rhinitis

Intranasal

Children ≥2 years of age: 1 spray (5.2 mg) in each nostril 3 or 4 times daily given at regular intervals (morning, noon, dinner, bedtime) for ≤12 weeks. When necessary, may be used up to 6 times daily.

Allergic Ocular Disorders

Ophthalmic

Children ≥4 years of age: 1 or 2 drops in each eye 4–6 times daily at regular intervals.

Do not exceed recommended frequency of administration.

Adults

Allergic Rhinitis

Intranasal

1 spray (5.2 mg) in each nostril 3 or 4 times daily (morning, noon, dinner, bedtime) for ≤12 weeks. When necessary, may be used up to 6 times daily.

Allergic Ocular Disorders

Ophthalmic

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

Contraindications

• Known hypersensitivity to cromolyn sodium or any ingredient in the formulations.

Warnings/Precautions

Warnings

General Precautions

Ocular Effects

Ophthalmic solution: Transient stinging or burning sensation may occur.

Respiratory Effects

Nasal solution: Transient nasal stinging and/or sneezing may occur immediately. Discontinue drug if nasal irritation occurs.

Specific Populations

Pregnancy

Category B.

Lactation

Not known whether cromolyn is distributed into milk. Use ophthalmic solution with caution. With nasal spray, consult a clinician prior to use.

Pediatric Use

Safety and efficacy of cromolyn sodium given as the nasal solution or ophthalmic solution not established in children <2 or <4 years of age, respectively.

Geriatric Use

Ophthalmic solution: No differences in safety or efficacy relative to younger adults.

Common Adverse Effects

Nasal solution: Nasal burning and stinging, nasal irritation, sneezing.

Ophthalmic solution: Transient ocular stinging or burning upon instillation.

General

• For patients with seasonal or perennial rhinitis, continue therapy throughout the period of allergen exposure (e.g., until the pollen season is over or contact with allergen has ceased).

• If exposure to allergens cannot be predicted, initiate therapy at the first sign of nasal symptoms.

• Should not use other ocular agents with ophthalmic solution unless directed by a clinician. However, may use corticosteroids with ophthalmic solution.

Administration

Administer intranasally or topically to the eye.

Administer at regular intervals.

Intranasal Administration

Parents or care providers must supervise use by young children. In very young children, an adult should administer nasal solution. Use care when inserting the nozzle into the nose to avoid injury.

Prior to administration, clear nasal passages by blowing the nose; administration of a topical nasal decongestant may be necessary. Inhale through the nose during administration.

For maximum therapeutic effect, initiate therapy before (e.g., ≤1–2 weeks before) and continue at regular intervals during the period of allergen exposure.

Ophthalmic Administration

Applied topically to the eye as an ophthalmic solution just inside the lower eyelid; patients should avoid applying the solution directly on the cornea.

To avoid contamination of dropper tip and solution, avoid touching the tip of the dispensing dropper or container to the eye, fingers, or any other surface.

Dosage

Available as cromolyn sodium.

Nasal pump delivers 5.2 mg of cromolyn sodium per metered spray.

One drop of cromolyn sodium ophthalmic solution contains approximately 1.6 mg of cromolyn sodium.

Pediatric Patients

Allergic Rhinitis

Intranasal

Children ≥2 years of age: 1 spray (5.2 mg) in each nostril 3 or 4 times daily given at regular intervals (morning, noon, dinner, bedtime) for ≤12 weeks. When necessary, may be used up to 6 times daily.

Allergic Ocular Disorders

Ophthalmic

Children ≥4 years of age: 1 or 2 drops in each eye 4–6 times daily at regular intervals.

Do not exceed recommended frequency of administration.

Adults

Allergic Rhinitis

Intranasal

1 spray (5.2 mg) in each nostril 3 or 4 times daily (morning, noon, dinner, bedtime) for ≤12 weeks. When necessary, may be used up to 6 times daily.

Allergic Ocular Disorders

Ophthalmic

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