Cromolyn Sodium (EENT) (Monograph)

Cromolyn Sodium (EENT) (Monograph)

introduction

Uses for Cromolyn Sodium (EENT)

Allergic rhinitis

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

Should not be used as self-medication to treat sinusitis† [off-label], asthma† [off-label], or cold symptoms† [off-label].

Allergic eye diseases

Symptomatic treatment of certain allergic eye diseases (e.g. vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis).

Used to treat giant papillary conjunctivitis† [off-label].

Cromolyn sodium (EENT) dosage and administration.

Generally

• In patients with seasonal or perennial rhinitis, therapy should be continued throughout the period of allergen exposure (e.g., until the pollen season has passed or contact with the allergen has ceased).

• If exposure to allergens is unpredictable, initiate therapy at the first sign of nasal symptoms.

• No other ophthalmic agents should be used with ophthalmic solution unless directed by a physician. However, corticosteroids may be used along with an ophthalmic solution.

Administration

Administer intranasally or topically to the eye.

Administer at regular intervals.

Intranasal administration

Parents or caregivers must supervise use by young children. For very young children, an adult should administer the nasal solution. Be careful when inserting the nozzle into your nose to avoid injury.

Before administration, clear the nasal passages by blowing your nose. Administration of a topical nasal decongestant may be necessary. When administering, inhale through the nose.

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

Ophthalmological administration

Apply topically to the eye directly in the lower eyelid as an ophthalmic solution; Patients should avoid applying the solution directly to the cornea.

To avoid contamination of the pipette tip and solution, avoid allowing the tip of the pipette or container to touch the eye, fingers, or other surfaces.

dosage

Available as cromolyn sodium.

The nasal pump delivers 5.2 mg cromolyn sodium per metered spray.

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

Pediatric patients

Allergic rhinitis

Intranasally

Children ≥ 2 years: 1 spray (5.2 mg) in each nostril 3 or 4 times daily at regular intervals (morning, noon, evening, bedtime) administered for ≤ 12 weeks. If necessary, it can be used up to 6 times a day.

Allergic eye diseases

Ophthalmology

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

Do not exceed the recommended frequency of administration.

Adult

Allergic rhinitis

Intranasally

1 spray (5.2 mg) in each nostril 3 or 4 times daily (morning, midday, evening, at bedtime) for ≤12 weeks. If necessary, it can be used up to 6 times a day.

Allergic eye diseases

Ophthalmology

Apply 1 or 2 drops in each eye at regular intervals 4-6 times a day.

Cromolyn Sodium (EENT) Precautions

Contraindications

• Known hypersensitivity to cromolyn sodium or any of the components of the formulations.

Warnings/Precautions

General precautions

Eye effects

Eye solution: Temporary stinging or burning may occur.

Effects on the respiratory system

Nasal solution: Temporary nasal stinging and/or sneezing may occur immediately. If nasal irritation occurs, discontinue the medication.

Specific populations

pregnancy

Category B

lactation

It is not known whether cromolyn passes into milk. Use ophthalmic solution with caution. For nasal spray, consult a doctor before use.

Pediatric use

The safety and effectiveness of cromolyn sodium administered as a nasal solution or ophthalmic solution have not been established in children <2 or <4 years of age.

Geriatric use

Ophthalmic solution: No differences in safety or effectiveness compared to younger adults.

Common side effects

Nasal solution: burning and stinging in the nose, nasal irritation, sneezing.

Eye solution: Temporary stinging or burning in the eye when instilled.

Cromolyn sodium (EENT) pharmacokinetics

absorption

Bioavailability

Approximately <7 or 0.03% is absorbed following an intranasal dose and an ophthalmic dose, respectively.

beginning

Nasal solution: Improvement may take several days; The best effect is only observed after 1-2 weeks.

Eye Solution: Improvement is usually noted within a few days; Sometimes up to 6 weeks of treatment was required to see improvement.

distribution

extent

Does not pass well through most biological membranes.

Crosses the placenta minimally (<0.1%) and is distributed minimally into milk in animals (<0.001% of a dose).

Elimination

Half-life

81 minutes.

stability

storage

Intranasally

Nasal solution

20-25°C; protect from light.

Ophthalmology

Eye solution

20-25°C or 15-30°C, depending on the manufacturer; protect from light. Store in the original box.

Actions

• Works primarily through a local effect on the nasal mucosa or eyes.

• Inhibits the degranulation of sensitized mast cells that occurs following exposure to certain antigens. Inhibits the release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (slow-reacting substance of anaphylaxis). [SRS-A]) from sensitized mast cells. Inhibits phospholipase A-induced mast cell degranulation and subsequent release of chemical mediators in vitro.

• No direct antihistamine, anticholinergic, antiserotonin, anti-inflammatory, vasoconstrictor or corticosteroid-like properties.

Advice for patients

• It is important to provide the patient with a copy of the manufacturer's patient information.

• It is important that physicians educate patients on proper use, including the correct administration of whichever dosage form is used.

• For nasal solution, it is important to tell a doctor about symptoms such as fever, discolored nasal discharge, sinus pain, or wheezing before use.

• Importance of administering medicines at regular intervals.

• It is important to avoid contact with allergens.

• It is important to advise patients with seasonal or perennial allergic rhinitis to initiate therapy early (e.g. ≤ 1-2 weeks before) and to continue therapy at regular intervals during the period of allergen exposure.

• With intranasal cromolyn, it is important to advise patients with allergic rhinitis to discontinue therapy and consult a doctor if symptoms worsen, new symptoms appear, symptoms do not improve within 2 weeks of starting treatment, or if treatment is required for longer than 12 weeks.

• It is important to stop taking the medication and contact a doctor if shortness of breath, wheezing, hives, or swelling in the mouth or throat or chest tightness occur.

• It is important not to wear contact lenses during treatment with cromolyn ophthalmic solution.

• It is important for women to tell doctors if they are pregnant, plan to become pregnant, or want to breastfeed.

• It is important to inform physicians about existing or planned concomitant therapies, including prescription and over-the-counter medications.

• It is important to inform patients of other important precautionary information. (See Precautions.)

Preparations

Excipients in commercial drug preparations may have clinically significant effects in some individuals; Details can be found on the respective product labeling.

For information about shortages of one or more of these drugs, visit the ASHP Drug Shortages Resource Center.

* Available from one or more manufacturers, distributors and/or repackagers under generic (non-proprietary) names

cromolyn sodium

AHFS DI Essentials™. © Copyright 2024, Selected changes April 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-Label: Use is not currently included in U.S. Food and Drug Administration-approved labeling.

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