Uses
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†.
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 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.
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 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†: 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
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 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 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
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: 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: 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†: 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.
Adults
Asthma
Oral Inhalation
Maximum 1.6 mg 4 times daily via metered-dose aerosol.
Special Populations
Dosage in Hepatic Impairment
Systemic Mastocytosis
Reduce oral dosage.
Asthma/Bronchospasm
Reduce aerosol inhalation dosage.
Dosage in Renal Impairment
Systemic Mastocytosis
Reduce oral dosage.
Asthma/Bronchospasm
Reduce aerosol inhalation dosage.
Geriatric Patients
Oral concentrate: Initiate dosage at the low end of the dosing range. (See Geriatric Use under Cautions.)
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