Class: Mast-cell Stabilizers
VA Class: RE100
CAS Number: 15826-37-6
Medically reviewed on Jul 2, 2018
Uses for Cromolyn Sodium
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).205 e Less effective than orally inhaled β2-adrenergic agonists in preventing exercise-induced bronchospasm.a
Symptomatic treatment of systemic mastocytosis (designated an orphan drug by US FDA for this use).a 203 Improves diarrhea, abdominal pain, pruritus, whealing, flushing, cognitive dysfunction, headaches, nausea, vomiting, and urticaria.a 203 Efficacy appears similar to chlorpheniramine maleate plus cimetidine in reducing the signs and symptoms of mastocytosis.203
Cromolyn Sodium Dosage and Administration
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).206 b When a response to therapy is evident, gradually reduce the dosage of concurrent agents.206 b (See Concomitant Corticosteroid Therapy under Cautions.)
Do not mix solution with fruit juice, milk, or food.a
Oral Inhalation Aerosol
Prime aerosol inhaler (aerosol preparation for oral inhalation no longer commercially available in US226 ) prior to first use and after a period of nonuse by pressing once (i.e., actuating) on the top of the metal canister.f
Patient should exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it.f Tilt inhaler upward and head backward and then inhale deeply through the mouth while actuating the inhaler.f Remove inhaler from the mouth, hold breath for a few seconds, and then exhale slowly.f Repeat if a second inhalation is necessary.f
Clean inhaler by removing the canister from the inhaler and cleaning the plastic mouthpiece with warm water.f
Prevention of bronchospasm: Administer 10–15 minutes but ≤60 minutes before anticipated exercise or exposure to another precipitating factor.205
Solution for Nebulization
Unless otherwise stated, the dosage of cromolyn sodium via aerosol inhalation (aerosol preparation for oral inhalation no longer commercially available in US226 ) is expressed as the amount delivered from the mouthpiece of the inhaler per metered spray.b The oral aerosol inhaler delivers approximately 1 mg from the valve and 800 mcg per metered spray from the mouthpiece.b The 8.1- or 14.2-g canister delivers at least 112 or 200 metered sprays, respectively.b f
Dosage may be increased after 2–3 weeks, according to clinical response.203
Reduce dosage to minimum effective level when an adequate response is achieved.203
Children 2–14 years of age: Initially, 100 mg 4 times daily 15–20 minutes before meals has been used.a If satisfactory control of symptoms is not achieved within 2–3 weeks, may double dosage but should not exceed 40 mg/kg daily.a
Reduce dosage to minimum effective level when an adequate response is achieved.a
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.a Optimal dosage must be individualized.a
Aerosol inhalation (no longer commercially available in US226 ) in children ≥5 years of age: 1.6 mg (2 inhalations) 4 times daily.205 f Lower dosage may be effective, especially in younger patients.205 f Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times (2 inhalations per dose) daily.b
Inhalation solution for nebulization in children ≥2 years of age: 20 mg 4 times daily at regular intervals.206 Following stabilization, gradually reduce the frequency of administration from 4 to 3 times daily.206
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.205 206
Prevention of Bronchospasm
Aerosol inhalation (no longer commercially available in US226 ) 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.205 f
Reduce dosage to minimum effective level when an adequate response is achieved.a
Aerosol inhalation (no longer commercially available in US226 ): 1.6 mg (2 inhalations) 4 times daily.205 Following stabilization, gradually reduce the frequency of administration from 4 to 3 and then 3 to 2 times daily.b
Prevention of Bronchospasm
Children ≥2 years of age: Maximum 40 mg/kg daily.203
Reduce oral dosage.203
Reduce oral dosage.203
Oral concentrate: Initiate dosage at the low end of the dosing range.203 (See Geriatric Use under Cautions.)
Cautions for Cromolyn Sodium
Cromolyn is not a bronchodilator and has a slow onset of action; metered-dose aerosol (no longer commercially available in US226 ) or solution for oral inhalation should not be used for relief of acute bronchospasm, especially status asthmaticus.205 206
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.206 b Monitor patients closely during such dosage reduction to avoid exacerbation of asthma.206 b
Monitor patients closely when discontinuing cromolyn therapy in patients in whom the dosage of corticosteroid therapy has been reduced.206 b Exacerbations of asthma may require immediate therapy and an increase in corticosteroid dosage.206 b
Discontinue if eosinophilic pneumonia or pulmonary infiltrates with eosinophilia occurs.205
CAD or Cardiac Arrhythmia
Not known whether cromolyn is distributed into milk.205 203 206 Use with caution;205 203 206 weigh the potential benefits to the mother against the potential risks to the infant when considering therapy.b
Safety and efficacy of cromolyn sodium given as the oral concentrate,203 oral inhalation aerosol (no longer commercially available in US226 ),205 or oral inhalation solution206 e 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.203
Oral concentrate: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.c Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.203
Common Adverse Effects
Oral concentrate: Headache, diarrhea.203
Cromolyn Sodium Pharmacokinetics
Poorly absorbed from the GI tract; about 1% or less is absorbed following an oral dose.c
Oral concentrate: Beneficial effects on systemic mastocytosis apparent ≤2–6 weeks of therapy.c
Oral concentrate: Exacerbation of signs and symptoms of systemic mastocytosis occur within 2–3 weeks after discontinuance of the drug.c
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
Oral inhalation: Absorbed fraction rapidly excreted unchanged in urine and bile with approximately equal proportions being excreted via each route.206 b e Remainder of dose exhaled or deposited onto oropharynx, swallowed, and excreted in feces.206 b e
Aerosol/Solution for Inhalation
Aerosol (no longer commercially available in US226 ): 15–30°C.205 b Do not puncture aerosol canisters, use or store near heat or open flame, expose to temperatures >42°C, or place into fire or incinerator for disposal.b
Inhibits degranulation of sensitized mast cells.205 203 206 Inhibits release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (e.g., slow-reacting substance of anaphylaxis [SRS-A]214 from sensitized mast cells after exposure to antigens.a 3 5 6 10 12 33 205 203
Following oral inhalation, acts mainly through a local effect on the lung mucosa.a
Advice to Patients
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.
King Pharmaceuticals discontinued the manufacture of cromolyn sodium oral inhalation aerosol (Intal Inhaler) in 2009.226 FDA states that cromolyn sodium oral inhalation aerosol with chlorofluorocarbon (CFC) propellants will not be manufactured, sold, or dispensed in the US after December 31, 2010.227
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
For solution, concentrate (contained in flexible ampuls)
20 mg/mL (100 mg)
Solution, for nebulization
10 mg/mL (20 mg)*
Cromolyn Sodium Inhalation Solution
Intal Nebulizer Solution
AHFS DI Essentials. © Copyright 2018, Selected Revisions July 2, 2012. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
Only references cited for selected revisions after 1984 are available electronically.
3. Cox JS. Disodium cromoglycate: a specific inhibitor of reaginic antibody-antigen mechanisms. Nature. 1967; 216:1328-9. http://www.ncbi.nlm.nih.gov/pubmed/6080064?dopt=AbstractPlus
5. Anon. Disodium cromoglycate. Lancet. 1972; 2:1299.
6. Anon. Disodium cromoglycate in allergic respiratory disease. Br Med J. 1972; 2:159-61. http://www.ncbi.nlm.nih.gov/pubmed/4622784?dopt=AbstractPlus
10. Falliers CJ. Cromolyn sodium. J Allergy. 1971; 47:298-305. http://www.ncbi.nlm.nih.gov/pubmed/4104162?dopt=AbstractPlus
12. Orr TS, Cox JS. Disodium cromoglycate, an inhibitor of mast cell degranulation and histamine release induced by phospholipase A. Nature. 1969; 223: 197. http://www.ncbi.nlm.nih.gov/pubmed/4183038?dopt=AbstractPlus
33. Sheard P, Blair AM. Disodium cromoglycate activity in three in vitro models of immediate hypersensitivity reaction in the lung. Int Arch Allergy Appl Immunol. 1970; 217-24.
200. Brandstetter RD, Conetta R, Glazer B. Lactose intolerance associated with Intal capsules. N Engl J Med. 1986; 315:1613-4. http://www.ncbi.nlm.nih.gov/pubmed/3097545?dopt=AbstractPlus
201. Michet CJ Jr, Rakela J, Luthra HS. Auranofin-associated colitis and eosinophilia. Mayo Clin Proc. 1987; 62:142-4. http://www.ncbi.nlm.nih.gov/pubmed/3807438?dopt=AbstractPlus
202. Martin DM, Goldman JA, Gilliam J et al. Gold-induce eosinophilic enterocolitis: response to oral cromolyn sodium. Gastroenterology. 1981; 80:1567-70. http://www.ncbi.nlm.nih.gov/pubmed/6785145?dopt=AbstractPlus
203. Celltech Pharmaceuticals. Gastrocrom (cromolyn sodium) oral concentrate solution prescribing information. Rochester, NY; 2002 Apr.
205. King Pharmaceuticals. Intalinhaler (cromolyn sodium) inhalation aerosol prescribing information. Bristol, TN; 2004 Jul.
206. Aventis. Intal (cromolyn sodium) nebulizer inhalation solution prescribing information. 2Bridgewater, NJ; 2001 Oct.
207. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. 1997 Feb.
208. Kemp JP. Comprehensive asthma management: guidelines for clinicians. J Asthma. 1998; 35:601-20. http://www.ncbi.nlm.nih.gov/pubmed/9860081?dopt=AbstractPlus
209. Kemp JP. Guidelines update: where do the new therapies fit in the management of asthma? Drugs. 2000; 59(Suppl 1):23-8.
210. Allergan. Opticrom (cromolyn sodium) ophthalmic solution prescribing information. In: Physicians’ desk reference. 55th ed. Montvale, NJ: Medical Economics Company Inc; 2001:518-9.
212. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 2005 Oct. NIH/NHLBI Publication No. 02-3659. Available at NIH website. Accessed Nov 7, 2006. http://www.ginasthma.com
214. Drazen JM, Israel E, O’Byrne PM. Treatment of athma with drugs modifying the leukotriene pathway. N Engl J Med. 1999; 340:197-206. http://www.ncbi.nlm.nih.gov/pubmed/9895400?dopt=AbstractPlus
215. King Pharmaceuticals. Intal inhaler (cromolyn sodium) inhalation aerosol information for the patient. Bristol, TN; 2004 Jul.
216. Celltech Pharmaceuticals. Gastrocrom (cromolyn sodium) oral concentrate solution patient instructions. Rochester, NY; 2002 Apr.
221. GlaxoSmithKline. Advair HFA (fluticasone propionate and salmeterol) medication guide. Research Triangle Park, NC; 2006 Jun.
222. National Institutes of Health, National Heart, Lung, and Blood Institute. Global initiative for asthma: global strategy for asthma management and prevention. Bethesda, MD: National Institutes of Health. 2009 Dec. Available from: http://www.ginasthma.com. Accessed 2010 Sep 23. http://www.ginasthma.org
223. National Asthma Education and Prevention Program. Expert panel report III: guidelines for the diagnosis and management of asthma. 2007 Jul. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. Available from NIH website. Accessed Jul 27, 2008. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
224. British Thoracic Society/Scottish Intercollegiate Guidelines Network. Guidelines on the management of asthma: a national clinical guideline. London, Eng; British Thoracic Society. 2008 May. Available from BTS website. Accessed Dec 5, 2008. http://www.brit-thoracic.org.uk/portals/0/clinical%20information/asthma/guidelines.pdf
226. Eric Carter. Dear health care professional letter regarding decision to discontinue the manufacture of Intal Inhaler (cromolyn sodium inhalation aerosol). Cary, NC: King Pharmaceuticals, Inc; 2009 Jul 31. Available from FDA website. Accessed 2010 Oct 14. http://www.fda.gov/downloads/Drugs/DrugsSafety/DrugShortages/ucm175032.pdf
227. Food and Drug Administration. Asthma and COPD inhalers that contain ozone-depleting CFCs to be phased out; alternative treatments available. 2010 Apr 13. Available from FDA website. Accessed 2010 Oct 14. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208302.htm
a. AHFS drug information 2003. McEvoy GK, ed. Cromolyn Sodium. Bethesda, MD: American Society of Health-System Pharmacists; 2003:3576-3580.
b. King Pharmaceuticals Inc. Intal Inhaler (cromolyn sodium) inhalation aerosol prescribing information. Bristol, TN; 2005Sep.
c. Azur Pharma Inc. Gastrocrom (cromolyn sodium) oral concentrate prescribing information. New York, NY; 2006 Mar.
d. Azur Pharma Inc. Gastrocrom (cromolyn sodium) oral concentrate patient instructions. New York, NY; 2006 Mar.
e. Dey. Cromolyn Sodium inhalation solution prescribing information. Napa, CA; 2006 Jan.
f. King Pharmaceuticals. Intal inhaler (cromolyn sodium) inhalation aerosol information for the patient. Bristol, TN; 2005 Sep.
g. Dey. Cromolyn Sodium inhalation solution patient instructions. Napa, CA; 2006 Jan.
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