Introduction

Mast-cell stabilizer.

Uses for Cromolyn (Systemic, Oral Inhalation)

Asthma

Prevention of bronchial asthma symptoms.

Has been used as an alternative to low-dose inhaled corticosteroids in patients with mild persistent asthma, but is less effective and generally not preferred as initial therapy.

Not effective for treatment of acute attacks of asthma, especially status asthmaticus. (See Acute Bronchospasm under Warnings/Precautions.)

Prevention of Bronchospasm

Prevention of exercise-induced bronchospasm or that induced by exposure to other known precipitating factors (e.g., cold dry air, allergens, sulfur dioxide, toluene diisocyanate, environmental pollutants). Less effective than orally inhaled β₂-adrenergic agonists in preventing exercise-induced bronchospasm.

Systemic Mastocytosis

Symptomatic treatment of systemic mastocytosis (designated an orphan drug by US FDA for this use). Improves diarrhea, abdominal pain, pruritus, whealing, flushing, cognitive dysfunction, headaches, nausea, vomiting, and urticaria. Efficacy appears similar to chlorpheniramine maleate plus cimetidine in reducing the signs and symptoms of mastocytosis.

Food Allergy

Has been used for the prophylactic management of food allergy^{† [off-label]}.

Cromolyn (Systemic, Oral Inhalation) Dosage and Administration

General

Asthma

• Initiate oral inhalation therapy after acute asthma has been controlled, the airway is clear, and the patient is able to inhale adequately.

• When oral inhalation is added to existing therapy, initially do not change dosage of concurrent antiasthmatic agents (e.g., inhaled β₂-adrenergic agonist or inhaled corticosteroid). When a response to therapy is evident, gradually reduce the dosage of concurrent agents. (See Concomitant Corticosteroid Therapy under Cautions.)

Administration

Administer orally or via oral inhalation. Do not inject oral concentrate or use for oral inhalation therapy.

Administer at regular intervals.

Oral Administration

Oral Concentrate

Dilute just prior to administration; empty the contents of the ampul(s) into a glass of water and stir.

Administer as a diluted solution; patient should drink all of the resultant solution.

Do not mix solution with fruit juice, milk, or food.

Administer 30 minutes before meals and at bedtime.

Oral Inhalation

Oral Inhalation Aerosol

Prime aerosol inhaler (aerosol preparation for oral inhalation no longer commercially available in US ) prior to first use and after a period of nonuse by pressing once (i.e., actuating) on the top of the metal canister.

Canister should be at room temperature prior to use; shake well prior to actuation.

Patient should exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it. Tilt inhaler upward and head backward and then inhale deeply through the mouth while actuating the inhaler. Remove inhaler from the mouth, hold breath for a few seconds, and then exhale slowly. Repeat if a second inhalation is necessary.

Avoid spraying into the eyes.

Clean inhaler by removing the canister from the inhaler and cleaning the plastic mouthpiece with warm water.

Discard canister after the labeled number of actuations.

Prevention of bronchospasm: Administer 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to another precipitating factor.

Solution for Nebulization

Administer oral inhalation solution by nebulization using a power-operated nebulizer with an adequate flow rate and suitable face mask. Do not use hand-operated nebulizers.

Administer by nebulization for young children who have difficulty using the oral aerosol inhaler (no longer commercially available in US ).

Safety and stability of oral inhalation solution when mixed with other drugs in the nebulizer not established.

Prevention of bronchospasm: Administer 10–15 minutes before anticipated exercise or exposure to another precipitating factor.

Dosage

Available as cromolyn sodium; dosage expressed in terms of the salt.

Unless otherwise stated, the dosage of cromolyn sodium via aerosol inhalation (aerosol preparation for oral inhalation no longer commercially available in US ) is expressed as the amount delivered from the mouthpiece of the inhaler per metered spray. The oral aerosol inhaler delivers approximately 1 mg from the valve and 800 mcg per metered spray from the mouthpiece. The 8.1- or 14.2-g canister delivers at least 112 or 200 metered sprays, respectively.

Pediatric Patients

Systemic Mastocytosis

Oral

Full-term neonates and infants <2 years of age^{† [off-label]}: Initially, 20 mg/kg daily in 4 divided doses. (See Pediatric Use under Cautions.)

Children 2–12 years of age: Initially, 100 mg 4 times daily.

Children ≥13 years of age: Initially, 200 mg 4 times daily.

Dosage may be increased after 2–3 weeks, according to clinical response.

Reduce dosage to minimum effective level when an adequate response is achieved.

Food Allergy† [off-label]

Oral

Children 2–14 years of age: Initially, 100 mg 4 times daily 15–20 minutes before meals has been used. If satisfactory control of symptoms is not achieved within 2–3 weeks, may double dosage but should not exceed 40 mg/kg daily.

Reduce dosage to minimum effective level when an adequate response is achieved.

Children 2–14 years of age requiring occasional therapy (e.g., when avoidance of allergenic foods cannot be assured): 100 mg about 15 minutes before meal suggested. Optimal dosage must be individualized.

Asthma

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ) in children ≥5 years of age: 1.6 mg (2 inhalations) 4 times daily. Lower dosage may be effective, especially in younger patients. Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times (2 inhalations per dose) daily.

Inhalation solution for nebulization in children ≥2 years of age: 20 mg 4 times daily at regular intervals. Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.

If control deteriorates at a reduced dosage (<4 doses daily), with or without concurrent agents at a reduced dosage, may need to increase the dosage of cromolyn sodium and reinitiate or increase the dosage of concurrent agent.

Prevention of Bronchospasm

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ) in children ≥5 years of age: 1.6 mg (2 inhalations) 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to precipitating factor.

Inhalation solution for nebulization in children ≥2 years of age: 20 mg 10–15 minutes before anticipated exercise or exposure to precipitating factor.

Adults

Systemic Mastocytosis

Oral

Initially, 200 mg 4 times daily. Dosage may be increased after 2–3 weeks, according to clinical response. Reduce dosage to minimum effective level when an adequate response is achieved.

Food Allergy† [off-label]

Oral

Initially, 200 mg 4 times daily given 15–20 minutes before meals has been used. If satisfactory control of symptoms not achieved within 2–3 weeks, may double dosage.

Reduce dosage to minimum effective level when an adequate response is achieved.

Adults requiring occasional therapy (e.g., when avoidance of allergenic foods cannot be assured): 200 mg about 15 minutes before meal suggested. Optimal dosage must be individualized.

Asthma

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ): 1.6 mg (2 inhalations) 4 times daily. Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times daily.

Inhalation solution for nebulization: 20 mg 4 times daily. Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.

Prevention of Bronchospasm

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ): 1.6 mg (2 inhalations) 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to precipitating factor.

Inhalation solution for nebulization: 20 mg 10–15 minutes before anticipated exercise or exposure to precipitating factor.

Prescribing Limits

Pediatric Patients

Systemic Mastocytosis

Oral

Infants <6 months age^{† [off-label]}: Maximum 20 mg/kg daily.

Children ≥2 years of age: Maximum 40 mg/kg daily.

Asthma

Oral Inhalation

Children ≥5 years of age: Maximum 1.6 mg 4 times daily via metered-dose aerosol (no longer commercially available in US ).

Adults

Asthma

Oral Inhalation

Maximum 1.6 mg 4 times daily via metered-dose aerosol (no longer commercially available in US ).

Special Populations

Hepatic Impairment

Systemic Mastocytosis

Reduce oral dosage.

Asthma/Bronchospasm

Reduce aerosol inhalation (no longer commercially available in US ) dosage.

Renal Impairment

Systemic Mastocytosis

Reduce oral dosage.

Asthma/Bronchospasm

Reduce aerosol inhalation (no longer commercially available in US ) dosage.

Geriatric Patients

Oral concentrate: Initiate dosage at the low end of the dosing range. (See Geriatric Use under Cautions.)

Contraindications

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

Warnings/Precautions

Warnings

Acute Bronchospasm

Cromolyn is not a bronchodilator and has a slow onset of action; metered-dose aerosol (no longer commercially available in US ) or solution for oral inhalation should not be used for relief of acute bronchospasm, especially status asthmaticus.

Bronchospasm, rarely severe, and/or cough reported following oral inhalation. Cromolyn may need to be discontinued despite administration of a bronchodilator.

Concomitant Corticosteroid Therapy

In corticosteroid-dependent asthmatic patients receiving cromolyn sodium for several weeks, make an attempt to gradually reduce the dosage of corticosteroids even if symptomatic improvement in asthma is not observed. Monitor patients closely during such dosage reduction to avoid exacerbation of asthma.

Monitor patients closely when discontinuing cromolyn therapy in patients in whom the dosage of corticosteroid therapy has been reduced. Exacerbations of asthma may require immediate therapy and an increase in corticosteroid dosage.

Eosinophilic Pneumonia

Discontinue if eosinophilic pneumonia or pulmonary infiltrates with eosinophilia occurs.

CAD or Cardiac Arrhythmia

Metered-dose aerosol inhalation (no longer commercially available in US ) contains fluorocarbon propellants; use not recommended in patients with CAD or a history of cardiac arrhythmia.

Sensitivity Reactions

Severe anaphylactic reactions reported.

Specific Populations

Pregnancy

Category B.

Lactation

Not known whether cromolyn is distributed into milk. Use with caution; weigh the potential benefits to the mother against the potential risks to the infant when considering therapy.

Pediatric Use

Use with caution in pediatric patients. Consider benefits versus risks of long-term therapy.

Safety and efficacy of cromolyn sodium given as the oral concentrate, oral inhalation aerosol (no longer commercially available in US ), or oral inhalation solution not established in children <2, <5, or <2 years of age, respectively.

Treatment of systemic mastocytosis in full-term neonates and infants <2 years of age is recommended only if disease is severe and incapacitating and if benefits clearly outweigh risks.

Geriatric Use

Oral concentrate: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.

Aerosol inhalation (no longer commercially available in US ): Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Common Adverse Effects

Oral concentrate: Headache, diarrhea.

Aerosol inhalation (no longer commercially available in US ): Irritation or dryness of the throat, bad taste, cough, wheezing, nausea.

Solution for oral inhalation: Nasal congestion, cough, sneezing, wheezing, nausea.

General

Asthma

• Initiate oral inhalation therapy after acute asthma has been controlled, the airway is clear, and the patient is able to inhale adequately.

• When oral inhalation is added to existing therapy, initially do not change dosage of concurrent antiasthmatic agents (e.g., inhaled β₂-adrenergic agonist or inhaled corticosteroid). When a response to therapy is evident, gradually reduce the dosage of concurrent agents. (See Concomitant Corticosteroid Therapy under Cautions.)

Administration

Administer orally or via oral inhalation. Do not inject oral concentrate or use for oral inhalation therapy.

Administer at regular intervals.

Oral Administration

Oral Concentrate

Dilute just prior to administration; empty the contents of the ampul(s) into a glass of water and stir.

Administer as a diluted solution; patient should drink all of the resultant solution.

Do not mix solution with fruit juice, milk, or food.

Administer 30 minutes before meals and at bedtime.

Oral Inhalation

Oral Inhalation Aerosol

Prime aerosol inhaler (aerosol preparation for oral inhalation no longer commercially available in US ) prior to first use and after a period of nonuse by pressing once (i.e., actuating) on the top of the metal canister.

Canister should be at room temperature prior to use; shake well prior to actuation.

Patient should exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it. Tilt inhaler upward and head backward and then inhale deeply through the mouth while actuating the inhaler. Remove inhaler from the mouth, hold breath for a few seconds, and then exhale slowly. Repeat if a second inhalation is necessary.

Avoid spraying into the eyes.

Clean inhaler by removing the canister from the inhaler and cleaning the plastic mouthpiece with warm water.

Discard canister after the labeled number of actuations.

Prevention of bronchospasm: Administer 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to another precipitating factor.

Solution for Nebulization

Administer oral inhalation solution by nebulization using a power-operated nebulizer with an adequate flow rate and suitable face mask. Do not use hand-operated nebulizers.

Administer by nebulization for young children who have difficulty using the oral aerosol inhaler (no longer commercially available in US ).

Safety and stability of oral inhalation solution when mixed with other drugs in the nebulizer not established.

Prevention of bronchospasm: Administer 10–15 minutes before anticipated exercise or exposure to another precipitating factor.

Dosage

Available as cromolyn sodium; dosage expressed in terms of the salt.

Unless otherwise stated, the dosage of cromolyn sodium via aerosol inhalation (aerosol preparation for oral inhalation no longer commercially available in US ) is expressed as the amount delivered from the mouthpiece of the inhaler per metered spray. The oral aerosol inhaler delivers approximately 1 mg from the valve and 800 mcg per metered spray from the mouthpiece. The 8.1- or 14.2-g canister delivers at least 112 or 200 metered sprays, respectively.

Pediatric Patients

Systemic Mastocytosis

Oral

Full-term neonates and infants <2 years of age^{† [off-label]}: Initially, 20 mg/kg daily in 4 divided doses. (See Pediatric Use under Cautions.)

Children 2–12 years of age: Initially, 100 mg 4 times daily.

Children ≥13 years of age: Initially, 200 mg 4 times daily.

Dosage may be increased after 2–3 weeks, according to clinical response.

Reduce dosage to minimum effective level when an adequate response is achieved.

Food Allergy† [off-label]

Oral

Children 2–14 years of age: Initially, 100 mg 4 times daily 15–20 minutes before meals has been used. If satisfactory control of symptoms is not achieved within 2–3 weeks, may double dosage but should not exceed 40 mg/kg daily.

Reduce dosage to minimum effective level when an adequate response is achieved.

Children 2–14 years of age requiring occasional therapy (e.g., when avoidance of allergenic foods cannot be assured): 100 mg about 15 minutes before meal suggested. Optimal dosage must be individualized.

Asthma

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ) in children ≥5 years of age: 1.6 mg (2 inhalations) 4 times daily. Lower dosage may be effective, especially in younger patients. Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times (2 inhalations per dose) daily.

Inhalation solution for nebulization in children ≥2 years of age: 20 mg 4 times daily at regular intervals. Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.

If control deteriorates at a reduced dosage (<4 doses daily), with or without concurrent agents at a reduced dosage, may need to increase the dosage of cromolyn sodium and reinitiate or increase the dosage of concurrent agent.

Prevention of Bronchospasm

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ) in children ≥5 years of age: 1.6 mg (2 inhalations) 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to precipitating factor.

Inhalation solution for nebulization in children ≥2 years of age: 20 mg 10–15 minutes before anticipated exercise or exposure to precipitating factor.

Adults

Systemic Mastocytosis

Oral

Initially, 200 mg 4 times daily. Dosage may be increased after 2–3 weeks, according to clinical response. Reduce dosage to minimum effective level when an adequate response is achieved.

Food Allergy† [off-label]

Oral

Initially, 200 mg 4 times daily given 15–20 minutes before meals has been used. If satisfactory control of symptoms not achieved within 2–3 weeks, may double dosage.

Reduce dosage to minimum effective level when an adequate response is achieved.

Adults requiring occasional therapy (e.g., when avoidance of allergenic foods cannot be assured): 200 mg about 15 minutes before meal suggested. Optimal dosage must be individualized.

Asthma

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ): 1.6 mg (2 inhalations) 4 times daily. Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times daily.

Inhalation solution for nebulization: 20 mg 4 times daily. Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.

Prevention of Bronchospasm

Oral Inhalation

Aerosol inhalation (no longer commercially available in US ): 1.6 mg (2 inhalations) 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to precipitating factor.

Inhalation solution for nebulization: 20 mg 10–15 minutes before anticipated exercise or exposure to precipitating factor.

Prescribing Limits

Pediatric Patients

Systemic Mastocytosis

Oral

Infants <6 months age^{† [off-label]}: Maximum 20 mg/kg daily.

Children ≥2 years of age: Maximum 40 mg/kg daily.

Asthma

Oral Inhalation

Children ≥5 years of age: Maximum 1.6 mg 4 times daily via metered-dose aerosol (no longer commercially available in US ).

Adults

Asthma

Oral Inhalation

Maximum 1.6 mg 4 times daily via metered-dose aerosol (no longer commercially available in US ).

Special Populations

Hepatic Impairment

Systemic Mastocytosis

Reduce oral dosage.

Asthma/Bronchospasm

Reduce aerosol inhalation (no longer commercially available in US ) dosage.

Renal Impairment

Systemic Mastocytosis

Reduce oral dosage.

Asthma/Bronchospasm

Reduce aerosol inhalation (no longer commercially available in US ) dosage.

Geriatric Patients

Oral concentrate: Initiate dosage at the low end of the dosing range. (See Geriatric Use under Cautions.)