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November 26, 2025
Brand Name :
N/A
Synonyms :
cromolyn sodium, inhaled
Class :
Mast cell stabilizers
Dosage forms and strengths Â
nebulization solutionÂ
10 mg/mlÂ
Administer 20 mg as an inhaler through nebulization four times a day
The dose may be reduced to twice/thrice a day when the condition is stable
Indicated for bronchospasm prophylaxis (Allergen/Exercise- induced)
Give a 20 mg dose as a single administration between 10 to 15 minutes before engaging in exposure to allergens or exercise
Ensuring it is not administered later than 1 hour
Dosage forms and strengths Â
Nebulization solutionÂ
10mg/mLÂ Â
Age ≥2 years:
Administer 20 mg as an inhaler through nebulization four times a day
The dose may be reduced to twice/thrice a day when the condition is stable
Indicated for bronchospasm prophylaxis (Allergen/Exercise-induced)
Age 2 years:
Give a 20 mg dose as a single administration between 10 to 15 minutes before engaging in exposure to allergens or exercise
Ensuring it is not administered later than 1 hour
Refer adult dosingÂ
Actions and Spectrum:Â
Action:Â
Mast Cell Stabilization: Cromolyn sodium prevents the release of inflammatory substances such as histamine from mast cells. It does so by stabilizing the mast cell membranes, thus inhibiting the release of these inflammatory mediators.Â
Anti-inflammatory: By preventing the release of histamine and other inflammatory compounds, cromolyn sodium helps in reducing inflammation in the airways.Â
Spectrum:Â
Asthma Management: Cromolyn sodium is used as a preventive medication in asthma management. It is especially effective in individuals with mild to moderate asthma or as an adjunctive therapy in severe cases.Â
Frequency not defined Â
WheezingÂ
SneezingÂ
MigraineÂ
FatigueÂ
NauseaÂ
Nasal congestionÂ
Chest painÂ
PalpitationÂ
FlushingÂ
Black Box Warning:Â Â
None
Contraindication/Caution:Â Â
Allergy to cromolyn Sodium: Cromolyn sodium should not be used by anyone who has a history of hypersensitivity or allergy to cromolyn sodium or any of its ingredients.Â
Acute Asthma Attacks: Cromolyn sodium is not intended for the treatment of acute asthma attacks. It works best as a preventive measure and is not suitable for immediate relief during an asthma attack. Patients should have a separate rescue inhaler for acute symptoms.Â
Severe Lung Disease: People with severe underlying lung diseases or conditions should use cromolyn sodium cautiously and under medical supervision. It may not be suitable for those with severe chronic obstructive pulmonary disease (COPD) or advanced stages of asthma.Â
Pregnancy and Breastfeeding: While limited information exists on the effects of cromolyn sodium during pregnancy or breastfeeding, it’s generally considered safe. However, it’s recommended that you consult a healthcare professional before using it during these periods.Â
Pregnancy warnings:    Â
Pregnancy category: N/AÂ
Lactation: Excreted into human milk is unknownÂ
Pregnancy Categories:        Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.Â
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category
Pharmacology:
Cromolyn sodium is a medication that belongs to the class of drugs known as mast cell stabilizers.Â
Pharmacodynamics:Â Â
Cromolyn sodium works by stabilizing mast cells, which are immune cells involved in the release of inflammatory mediators like histamine, leukotrienes, and other substances that contribute to allergic reactions and asthma symptoms. Â
It prevents these cells from releasing these mediators in response to various triggers such as allergens, exercise, or cold air. By stabilizing the mast cells, cromolyn sodium helps reduce airway inflammation and constriction. Â
Pharmacokinetics:Â
AbsorptionÂ
When inhaled, cromolyn sodium primarily acts locally in the respiratory tract.Â
The peak plasma time is achieved within 15 minutes,Â
DistributionÂ
Cromolyn sodium, upon reaching the respiratory tract, distributes locally in the lungs and airways.Â
MetabolismÂ
Cromolyn sodium undergoes minimal metabolism in the body.Â
It is not extensively metabolized in the liver or other tissues.Â
Excretion and EliminationÂ
The drug is primarily excreted through feces 98 percent, unabsorbed drugs.Â
The half life is 80 to 90 minutes.Â
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Administration: Â
If using a nebulizer solution, measure the prescribed dosage of cromolyn sodium as directed by your healthcare provider. If using an inhaler, ensure the device is assembled and primed according to the manufacturer’s instructions.Â
Patient information leafletÂ
Generic Name: cromolyn sodium, inhaledÂ
Why do we use cromolyn sodium, inhaled? Â
Cromolyn sodium is a preventive medication used in asthma management, especially in individuals with mild to moderate asthma. Â
It is also used to alleviate symptoms associated with allergic rhinitis (hay fever) caused by seasonal allergens or other triggers. Â
Cromolyn sodium can help reduce nasal congestion, sneezing, runny nose, and itching by preventing the release of histamines that cause these allergic reactions.Â