Brand names: Crolom, Nasalcrom
Drug class: Antiallergic Agents

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

Mast-cell stabilizer.^{208 215 b}

Uses for Cromolyn Sodium (EENT)

Allergic Rhinitis

Self-medication for the symptomatic prevention and treatment of seasonal or perennial allergic rhinitis.²⁰⁴ Provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and postnasal drip.^a

Should not use as self-medication for the treatment of sinus infection^{† [off-label]}, asthma^{† [off-label]}, or cold symptoms^{† [off-label]}.²⁰⁴

Allergic Ocular Disorders

Symptomatic treatment of certain allergic ocular disorders (e.g., vernal keratoconjunctivitis,^{205 208 213} vernal conjunctivitis,^{205 208 213} vernal keratitis).^{205 208 213 b}

Has been used for the treatment of giant papillary conjunctivitis^{† [off-label]}.²⁰⁷

Cromolyn Sodium (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).²¹⁵

• If exposure to allergens cannot be predicted, initiate therapy at the first sign of nasal symptoms.²¹⁵

• Should not use other ocular agents with ophthalmic solution unless directed by a clinician.^{206 209 216} However, may use corticosteroids with ophthalmic solution.²⁰⁵

Administration

Administer intranasally or topically to the eye.^{204 205 206}

Administer at regular intervals.^{204 205 206}

Intranasal Administration

Parents or care providers must supervise use by young children.²⁰⁴ In very young children, an adult should administer nasal solution.²¹⁵ Use care when inserting the nozzle into the nose to avoid injury.²¹⁵

Prior to administration, clear nasal passages by blowing the nose;²¹⁵ administration of a topical nasal decongestant may be necessary.^a Inhale through the nose during administration.²¹⁵

For maximum therapeutic effect, initiate therapy before (e.g., ≤1–2 weeks before) and continue at regular intervals during the period of allergen exposure.^{204 215}

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.^{205 206 209 216}

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.^{206 209 216}

Dosage

Available as cromolyn sodium.^{204 205}

Nasal pump delivers 5.2 mg of cromolyn sodium per metered spray.²⁰⁴

One drop of cromolyn sodium ophthalmic solution contains approximately 1.6 mg of cromolyn sodium.^{205 b}

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)²¹⁵ for ≤12 weeks.^{204 215} When necessary, may be used up to 6 times daily.^{204 215}

Allergic Ocular Disorders

Ophthalmic

Children ≥4 years of age: 1 or 2 drops in each eye 4–6 times daily at regular intervals.^{205 208 213 b}

Do not exceed recommended frequency of administration.^{205 208 213 b}

Adults

Allergic Rhinitis

Intranasal

1 spray (5.2 mg) in each nostril 3 or 4 times daily (morning, noon, dinner, bedtime)²¹⁵ for ≤12 weeks.^{204 215} When necessary, may be used up to 6 times daily.^{204 215}

Allergic Ocular Disorders

Ophthalmic

1 or 2 drops in each eye 4–6 times daily at regular intervals.^{205 208 213 b}

Cautions for Cromolyn Sodium (EENT)

Contraindications

• Known hypersensitivity to cromolyn sodium or any ingredient in the formulations.^{204 205 213}

Warnings/Precautions

General Precautions

Ocular Effects

Ophthalmic solution: Transient stinging or burning sensation may occur.^{205 208 213 b}

Respiratory Effects

Nasal solution: Transient nasal stinging and/or sneezing may occur immediately.^{204 215} Discontinue drug if nasal irritation occurs.²¹⁵

Specific Populations

Pregnancy

Category B.^{205 208 213 b}

Lactation

Not known whether cromolyn is distributed into milk.^{205 b} Use ophthalmic solution with caution.^{205 208 213 b} With nasal spray, consult a clinician prior to use.²⁰⁴

Pediatric Use

Safety and efficacy of cromolyn sodium given as the nasal solution²⁰⁴ or ophthalmic solution^{205 213 b} 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.^{208 213}

Common Adverse Effects

Nasal solution: Nasal burning and stinging, nasal irritation, sneezing.^{204 215 a}

Ophthalmic solution: Transient ocular stinging or burning upon instillation.^{205 208 213}

Cromolyn Sodium (EENT) Pharmacokinetics

Absorption

Bioavailability

Approximately <7 or 0.03% absorbed following an intranasal dose^a or an ophthalmic dose, respectively.^{205 213 b}

Onset

Nasal solution: Improvement may take several days; best effect not seen for 1–2 weeks.^{204 215}

Ophthalmic solution: Improvement usually noted in a few days; treatment for up to 6 weeks sometimes needed to see improvement.^{205 208 213 b}

Distribution

Extent

Does not cross most biologic membranes well.^a

Minimally crosses the placenta (<0.1%) and minimally distributed into milk (<0.001% of a dose) in animals.^a

Elimination

Half-life

81 minutes.^a

Stability

Storage

Intranasal

Nasal Solution

20–25°C; protect from light.^{204 215}

Ophthalmic

Ophthalmic Solution

20–25°C or 15–30°C, depending on manufacturer; protect from light.^{205 206 208 209 213 216 b} Store in original carton.^b

Actions

• Acts mainly through a local effect on the nasal mucosa or eyes.^{a 215}

• Inhibits degranulation of sensitized mast cells that occurs after exposure to specific antigens.^{205 213 b} Inhibits release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (slow-reacting substance of anaphylaxis [SRS-A])²¹⁴ from sensitized mast cells.^{3 5 6 10 12 33 205 208 212 213} Inhibits phospholipase A-induced mast cell degranulation and subsequent release of chemical mediators in vitro.^{205 208 b}

• No direct antihistamine, anticholinergic, antiserotonin, anti-inflammatory, vasoconstrictor, or corticosteroid-like properties.^{a b 205 213}

Advice to Patients

• Importance of providing patient a copy of manufacturer’s patient information.²⁰⁴

• Importance of clinicians instructing patients about proper use, including proper administration of the particular dosage form employed.^{205 208 213}

• With nasal solution, importance of informing a clinician of symptoms such as fever, discolored nasal discharge, sinus pain, or wheezing prior to use.²⁰⁴

• Importance of administration of drug at regular intervals.^{205 208 213 215 b}

• Importance of avoiding exposure to allergens.²¹⁵

• Importance of advising patients with seasonal or perennial allergic rhinitis to begin therapy before (e.g., ≤1–2 weeks before), and to continue therapy at regular intervals during, the period of allergen exposure.^{204 215}

• With intranasal cromolyn, importance of advising patients with allergic rhinitis to discontinue therapy and consult a clinician if symptoms worsen, new symptoms occur, symptoms do not begin to improve within 2 weeks of treatment initiation, or if treatment is required for longer than >12 weeks.^{204 215}

• Importance of discontinuing drug and contacting a clinician if shortness of breath, wheezing, hives or swelling of the mouth or throat, or chest tightness occurs.^{204 215}

• Importance of not wearing contact lenses during treatment with cromolyn ophthalmic solution.^{205 206 208 209 213 216}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.²⁰⁴

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.²⁰⁵

• Importance of informing patients of other important precautionary information.²⁰⁵ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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