Cromolyn Sodium Inhalation Solution

  • Asthma/COPD

Cromolyn Sodium Inhalation Solution Generic Name & Formulations

General Description

Cromolyn sodium 20mg/2mL; soln for inhalation.

Pharmacological Class

Mast cell stabilizer.

How Supplied

Contact supplier.


Store vials at 68° to 77°F (20° to 25°C).

Cromolyn Sodium Inhalation Solution Indications


Asthma prophylaxis. Prevention of bronchoconstriction before exposure to a known precipitant (eg, exercise).

Cromolyn Sodium Inhalation Solution Dosage and Administration

Adults and Children

<2 years: not recommended. ≥2 years: 20mg administered by power-operated nebulizer 4 times a day. Bronchoconstriction prevention: contents of 1 amp inhaled up to 60 minutes before precipitant.

Adults and Children

Management of bronchial asthma in adults and pediatric patients 2 years of age and older: usual starting dosage is the contents of 1 vial administered by nebulization 4 times daily at regular intervals.

Effect of cromolyn sodium inhalation solution therapy is dependent upon its administration at regular intervals, as directed. Cromolyn sodium inhalation solution should be introduced into the patient's therapeutic regimen when the acute episode has been controlled, the airway has been cleared and the patient is able to inhale adequately.

Prevention of acute bronchospasm following exercise or exposure to cold dry air, environmental agents (eg, animal danders, toluene diisocyanate, pollutants): usual dose is 1 vial administered via nebulization shortly before exposure to the precipitating factor.

Cromolyn sodium inhalation therapy in relation to other treatment for asthma:

Nonsteroidal agents

  • Cromolyn sodium inhalation solution should be added to the patient's existing treatment regimen (eg, bronchodilators).
  • An attempt may be made to decrease concomitant medication usage gradually if clinical response to cromolyn sodium inhalation solution is evident (usually within 2-4 weeks) and if asthma is under good control.
  • If concomitant medications are eliminated or required on no more than an as-needed basis, the frequency of administration of cromolyn sodium inhalation solution may be titrated downward to the lowest level consistent with the desired effect; usual decrease is from 4 to 3 vials per day, reduce gradually to avoid exacerbation.
  • In patients whose dosage has been titrated to fewer than 4 vials per day, an increase in the dose of cromolyn sodium inhalation solution and the introduction of, or increase in, symptomatic medications may be needed if the patient's clinical condition deteriorates.


  • In patients receiving corticosteroids for bronchial asthma management, dosage of corticosteroids should be maintained following the introduction of cromolyn sodium inhalation solution.
  • An attempt to decrease corticosteroids should be made if the patient improves.
  • Even if the corticosteroids-dependent patient fails to show symptomatic improvement following cromolyn sodium inhalation solution administration, the potential to decrease corticosteroids may still be present; gradual tapering (with close supervision) of corticosteroids may be attempted.
  • Consideration should be given to reinstituting corticosteroid therapy if a patient is subjected to significant stress, such as a severe asthmatic attack, surgery, trauma or severe illness while being treated or within 1 year (occasionally up to 2 years) after prolonged corticosteroid treatment has been terminated.
  • Continued close supervision of the patient is essential if for any reason cromolyn sodium inhalation solution is withdrawn in cases where its use permitted a reduction in corticosteroid use; severe manifestations of asthma may occur and may require immediate therapy and possible reintroduction of corticosteroids.

Cromolyn Sodium Inhalation Solution Contraindications

Not Applicable

Cromolyn Sodium Inhalation Solution Boxed Warnings

Not Applicable

Cromolyn Sodium Inhalation Solution Warnings/Precautions


Not for treatment of acute attack. Impaired renal or hepatic function: reduce dose. Reevaluate if no improvement after 4 weeks. Avoid abrupt cessation. Discontinue if eosinophilic pneumonia occurs. Coronary artery disease or arrhythmias (Inhaler). Pregnancy (Cat.B). Nursing mothers.


Cromonlyn sodium inhalation solution should not be used for treatment of acute asthma attacks.

Some patients may experience cough and/or bronchospasm following cromolyn sodium inhalation; patients who develop bronchospasm may not be able to continue cromolyn sodium administration. Very severe bronchospasm is rare but has been observed in some patients.

Asthma symptoms may recur if cromolyn sodium is reduced below the recommended dosage or discontinued.

Pregnancy Considerations

No adequate and well-controlled studies in pregnant women. Cromolyn sodium inhalation solution should only be used during pregnancy if it is clearly needed.

Nursing Mother Considerations

It is not known whether cromolyn sodium inhalation solution is excreted in the breast milk; caution should be exercised in nursing patients. 

Pediatric Considerations

The safety and effectiveness of cromolyn sodium inhalation solution have not been established in patients younger than 2 years old.

Geriatric Considerations

Clinical experience has not identified differences in responses to cromolyn sodium inhalation solution between elderly and younger patients.

Cromolyn Sodium Inhalation Solution Pharmacokinetics


Following inhalation, approximately 8% of the total cromolyn sodium dose administered is absorbed.


Half-life: 1.3 hours. 

Rapidly excreted unchanged, approximately equally divided between urine and bile. The remainder of the dose is either exhaled or deposited in the oropharynx, swallowed and excreted via the alimentary tract.

Cromolyn Sodium Inhalation Solution Interactions


Avoid use with isoproterenol during pregnancy.

Cromolyn Sodium Inhalation Solution Adverse Reactions

Adverse Reactions

Cough, nasal congestion, nausea, sneezing, and wheezing.

Cromolyn Sodium Inhalation Solution Clinical Trials

See Literature

Cromolyn Sodium Inhalation Solution Note


Formerly known under the brand name Intal.

Cromolyn Sodium Inhalation Solution Patient Counseling

Patient Counseling

Cromolyn sodium inhalation solution is recommended for use in a power driven nebulizer operated at an airflow rate of 6 to 8 liters per minute and equipped with a suitable face mask.

Breathe in through the mouth and out through the nose in a normal, relaxed manner. Nebulization should take approximately 5 to 10 minutes.

Do not stop taking cromolyn sodium inhalation solution or skip any doses without first consulting with your health care provider.

Bronchodilator-type medicine may be needed to treat occasional symptoms while taking cromolyn sodium inhalation solution on a regular basis.