Cromolyn sodium is an FDA-approved medication used for prophylaxis of mild to moderate bronchial asthma and adjunctive treatment of allergic rhinitis and systemic mast cell disease (mastocytosis) in both pediatric patients and adults. It is not immediate-acting and has no direct bronchodilator effects, and thus does not treat acute attacks of asthma. It is also available as an ophthalmic solution for the symptomatic treatment of certain allergic eye conditions such as vernal conjunctivitis, keratitis, and keratoconjunctivitis. Non-FDA labeled indications include the prevention of serious reactions to foods and the management of inflammatory bowel disease and superior limbic keratoconjunctivitis.
Cromolyn sodium is a mast cell stabilizer that prevents the subsequent release of inflammatory mediators, including histamine and leukotrienes, which cause allergic symptoms and bronchoconstriction. It inhibits mast cell degranulation, normally implicated in anaphylaxis following exposure to reactive allergens. Cromolyn sodium differs from antihistamine medications, which reduce the action of histamines following the release from mast cells. Unlike corticosteroids which inhibit the late response of antigen-induced asthmatic reactions, cromolyn sodium inhibits both immediate and late reactions.
The bioavailability of cromolyn sodium is 0.5 to 2%, with a half-life of 80 to 90 minutes. This drug is absorbed poorly via oral solution and takes 2 to 6 weeks for onset of action. The effect of cromolyn sodium on mast cells lasts for approximately 6 hours following administration. The majority of the drug (98%) is excreted in the feces unabsorbed, with the remainder excreted in the urine.
Cromolyn sodium is available as:
FDA-approved clinical indications direct dosing guidelines:
Non-FDA Labeled Indications:
The frequency of adverse effects remains unclear. Adverse effects vary depending on the route of administration.
Adverse events associated with oral solution include nausea, vomiting, diarrhea, abdominal pain, constipation, erythema, photosensitivity, urticaria, and angioedema.
There are reports of nasal congestion, sneezing, nasal itching, nosebleeds, rhinoconjunctivitis, and headaches with the use of cromolyn sodium nasal spray.
Additional adverse effects reported with the inhalation solution, including throat irritation and hoarseness, esophagitis, laryngeal and pharyngeal edema, drowsiness, dizziness, bronchial irritation, pulmonary infiltrates, and cough.
The ophthalmic solution may correlate with transient burning of eyes upon administration, eye dryness, puffiness, irritation, itchiness, rash, and styes.
Pregnancy Category B risk has not been ruled out. It is unknown if cromolyn sodium is excreted in breast milk.
The following are contraindications for the use of cromolyn sodium:
The clinician should closely monitor kidney and liver function in patients with hepatic or renal insufficiency and begin with a reduced dose. The effects of the medication may increase in patients with these medical conditions, thus increasing the chance of adverse effects. Patients with a history of cardiac arrhythmias or coronary artery disease (CAD) using inhalation solution should undergo cardiac follow up due to the contents of metered-dose inhaler propellants. Regular eye examinations are necessary when using cromolyn sodium ophthalmic solution. For individuals diagnosed with bronchial asthma, symptomatic improvement should have an assessment via pulmonary function tests.
Symptoms may reoccur when tapering or withdrawing the drug.
This drug is poorly absorbed and is low in toxicity. There has been no serious toxicity reported, and a specific toxic dose has not been established. There is not enough research verifying the efficacy or safety of cromolyn sodium use in pediatric patients less than 2-years-old.
Acute life-threatening reactions have been allergic. In the event of a hypersensitivity reaction, patients should receive treatment with antihistamines with or without beta-agonists, corticosteroids, and epinephrine. In the case of a severe hypersensitivity reaction, oxygen, antihistamines, epinephrine, corticosteroids, as well as ECG monitoring and IV fluids should be administered. No specific labs or testing are necessary unless indicated.
Management of mild to moderate toxicity is symptomatic and supportive. The clinician should correct any significant fluid and or electrolyte abnormalities in patients with vomiting or diarrhea. Severe toxicity is not expected following an overdose but managed with symptomatic and supportive treatment.
Cromolyn sodium is indicated as an adjunctive treatment for a variety of medical conditions and is available as an oral solution, ophthalmic solution, inhalation solution, and nasal spray. Although adverse effects and hypersensitivity reactions to the drug are rare, it is the responsibility of the members of an interprofessional healthcare team, including nurses, pharmacists, and clinicians, to recognize the clinical presentation and provide the appropriate management of potentially life-threatening sequelae if they occur.
In the event a patient has a severe hypersensitivity reaction to cromolyn sodium, the emergency department clinician and nurses must execute an effective, patient-centered treatment plan which includes:
Following a hypersensitivity reaction or severe adverse event, a thorough discussion of future drug therapy changes must occur with the health care provider. Through an interprofessional approach, cromolyn sodium can be safely and effectively used in the management of patient care. [Level V]
|||Kramer ON,Barkoff MS,Hernandez C, Mast Cell Activation Syndrome. Skinmed. 2017; [PubMed PMID: 29282192]|
|||Tefferi A,Pardanani A, Systemic mastocytosis: current concepts and treatment advances. Current hematology reports. 2004 May; [PubMed PMID: 15087068]|
|||Ben-Eli H,Solomon A, Topical antihistamines, mast cell stabilizers, and dual-action agents in ocular allergy: current trends. Current opinion in allergy and clinical immunology. 2018 Oct; [PubMed PMID: 30020258]|
|||OTC drugs for seasonal allergies. The Medical letter on drugs and therapeutics. 2019 Apr 22; [PubMed PMID: 31169808]|
|||Castells M,Butterfield J, Mast Cell Activation Syndrome and Mastocytosis: Initial Treatment Options and Long-Term Management. The journal of allergy and clinical immunology. In practice. 2019 Apr; [PubMed PMID: 30961835]|
|||Sharma S,Hashmi MF,Chakraborty RK, Asthma Medications 2020 Jan; [PubMed PMID: 30285350]|
|||Kjellman NI, Food allergy--treatment and prevention. Annals of allergy. 1987 Nov; [PubMed PMID: 3120629]|
|||Kuzubova NA,Lebedeva ES,Dvorakovskaya IV,Preobrazhenskaya TN,Surkova EA,Titova ON, [EFFECT OF MAST CELL DEGRANULATION BLOCKADE ON THE INFLAMMATION OUTCOME IN THE MODEL OF OBSTRUCTIVE LUNG PATHOLOGY]. Rossiiskii fiziologicheskii zhurnal imeni I.M. Sechenova. 2016 Jul; [PubMed PMID: 30193050]|
|||Kuzubova NA,Fedin AN,Lebedeva ES,Titova ON, [ROLE OF MAST CELLS IN BRONCHIAL CONTRACTION IN NONALLERGIC OBSTRUCTIVE LUNG PATHOLOGY]. Rossiiskii fiziologicheskii zhurnal imeni I.M. Sechenova. 2017 Feb; [PubMed PMID: 30199200]|
|||Hong JG,Wandalsen G,Murphy KR,Larenas-Linnemann D,El Beleidy A,Zaytseva OV,Pedersen SE, Nebulized Inhaled Corticosteroids in Asthma Treatment in Children ≤5 Years of Age: A Systematic Review and Global Expert Analysis. The journal of allergy and clinical immunology. In practice. 2020 Jan 29; [PubMed PMID: 32006721]|
|||Clift AD,Holzel A, Long-term therapy with sodium cromoglycate (intal, lomudal or aarane): effects and side effects. Annals of allergy. 1978 Nov; [PubMed PMID: 102223]|
|||Cromolyn 2006; [PubMed PMID: 30000450]|
|||Buonomo A,Altomonte G,De Pasquale T,Lombardo C,Pecora V,Sabato V,Colagiovanni A,Rizzi A,Aruanno A,Pascolini L,Patriarca G,Nucera E,Schiavino D, Allergic and non-allergic drug hypersensitivity reactions in children. International journal of immunopathology and pharmacology. 2010 Jul-Sep; [PubMed PMID: 20943060]|