Cromolyn Oral Inhalation

Cromolyn sodium oral inhalation is used as a preventive treatment — not a rescue medicine — for airway conditions triggered by asthma and environmental exposures.

• Management of bronchial asthma in adults and children (two years and older) who need daily, ongoing medication to control symptoms
• Prevention of acute bronchospasm (sudden airway tightening) triggered by exercise, cold dry air, animal dander, toluene diisocyanate, or environmental pollutants — taken as a single dose shortly before exposure

Cromolyn sodium works by preventing mast cells — immune cells found in the airways — from releasing irritating chemicals like histamine and SRS-A (a substance that causes airway swelling). When you breathe in an allergen or trigger, mast cells normally burst open (degranulate) and flood the airway with these chemicals, causing tightening and inflammation. Cromolyn sodium blocks that process before it starts. It has no antihistamine or anti-inflammatory effect on its own — it simply stops the trigger from setting off the chain reaction in the first place.

For ongoing asthma management, cromolyn sodium inhalation solution is typically inhaled via nebulizer four times a day at regular intervals. For preventing a reaction to a known trigger (like exercise or allergen exposure), one dose is inhaled shortly before the exposure. The medicine must be inhaled — swallowing it does not work.

• Start cromolyn sodium only after an acute asthma episode is under control and your airway is clear enough to inhale properly
• If your asthma improves over time, your doctor may gradually reduce the frequency — do not reduce it on your own
• Take doses at regular times; consistent use is what makes this medicine effective

Most people tolerate cromolyn sodium well — side effects are generally uncommon. The most frequently reported ones include:

• Cough
• Wheezing
• Nasal congestion
• Sneezing
• Nausea
• Stomachache
• Drowsiness

Rarely, serious reactions can occur — including severe allergic reactions (anaphylaxis), throat or face swelling (angioedema), bronchospasm, or joint swelling and pain. Seek emergency help or call your doctor right away if any of these develop.

• Not for active asthma attacks: Cromolyn sodium has no role in treating a severe, ongoing asthma attack (status asthmaticus). Always have a rescue inhaler on hand.
• Rare but serious allergic reactions: Anaphylaxis has been reported. Signs include sudden breathing difficulty, throat swelling, and hives — call 911 immediately if this happens.
• Do not stop suddenly if you've reduced corticosteroids: If cromolyn sodium has allowed you to lower your steroid dose, stopping cromolyn abruptly can trigger a severe asthma flare. Your doctor must supervise any changes.
• Corticosteroid tapering requires close supervision: Long-term steroid use affects your adrenal glands (the glands that help your body handle stress). Even after steroids are stopped, your body may need them again during serious illness, surgery, or a bad asthma attack — for up to two years after stopping.

There are limited drug interactions described in the label, but one important one to know:

• Isoproterenol during pregnancy: Animal studies found that combining cromolyn sodium with isoproterenol (a bronchodilator) during pregnancy increased the risk of fetal harm. If you are pregnant and using isoproterenol, talk to your doctor before taking cromolyn sodium.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Allergy to cromolyn sodium: Do not use this medicine if you have had a hypersensitivity (allergic) reaction to it before.
• Active asthma attack: Do not start or rely on this medicine during an acute episode — wait until the attack is controlled and you can inhale adequately.
• Pregnancy: Animal data suggest a potential risk when combined with isoproterenol; discuss with your doctor if you are pregnant or planning to be.
• Children: The inhalation solution via nebulizer is approved for children two years of age and older.
• Corticosteroid users: Tell your doctor if you take steroids for asthma — any reduction must be done very slowly and under medical supervision.
• Other asthma medications: Cromolyn sodium should be added to your existing regimen; do not use it as a replacement for bronchodilators or other treatments without your doctor's guidance.

There is no recognized clinical syndrome from a cromolyn sodium overdose. In animal studies, even very high doses caused toxicity only at extremely high levels far beyond any human dose, and inhalation studies in animals could not achieve toxic levels at all. If you are concerned about taking too much, contact a poison control center or your healthcare provider.

Cromolyn sodium prevents airway mast cells from releasing histamine and other inflammatory chemicals (like SRS-A) that cause bronchospasm and swelling. It does not directly constrict or dilate blood vessels, block histamine receptors, or reduce existing inflammation — its entire effect is upstream, preventing those chemical signals from being released in the first place.

Cromolyn sodium is poorly absorbed into the body — when inhaled, very little enters the bloodstream. The drug works locally in the airways rather than through a systemic (whole-body) effect. Because it is so poorly absorbed, swallowing the solution has no therapeutic benefit.

Store at 20°C to 25°C (68°F to 77°F) . PROTECT FROM LIGHT.