WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Cromolyn (inhalation) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Cromolyn sodium inhalation solution, USP is a prophylactic agent indicated in the management of patients with bronchial asthma.
In patients whose symptoms are sufficiently frequent to require a continuous program of medication, cromolyn sodium inhalation solution, USP is given by inhalation on a regular daily basis. The effect of cromolyn sodium is usually evident after several weeks of treatment, although some patients show an almost immediate response.
In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, etc, cromolyn sodium should be given shortly before exposure to the precipitating factor.
Dosage
For management of bronchial asthma in adults and pediatric patients (two years of age and over), the usual starting dosage is the contents of one vial administered by nebulization four times a day at regular intervals.
Drug stability and safety of cromolyn sodium inhalation solution when mixed with other drugs in a nebulizer have not been established.
Patients with chronic asthma should be advised that the effect of cromolyn sodium inhalation solution, USP therapy is dependent upon its administration at regular intervals, as directed. Cromolyn sodium inhalation solution, USP 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.
For the prevention of acute bronchospasm which follows exercise or exposure to cold dry air, environmental agents (e.g., animal danders, toluene diisocyanate, pollutants), etc., the usual dose is the contents of one vial administered by nebulization shortly before exposure to the precipitating factor.
It should be emphasized to the patient that the drug is poorly absorbed when swallowed and is not effective by this route of administration.
Cromolyn Sodium Inhalation Solution, USP Therapy in Relation to Other Treatments for Asthma
Non-steroidal agents
Cromolyn sodium inhalation solution, USP should be added to the patient's existing treatment regimen (e.g., bronchodilators). When a clinical response to cromolyn sodium inhalation solution, USP is evident, usually within two to four weeks, and if the asthma is under good control, an attempt may be made to decrease concomitant medication usage gradually.
If concomitant medications are eliminated or required on no more than a prn basis, the frequency of administration of cromolyn sodium inhalation solution, USP may be titrated downward to the lowest level consistent with the desired effect. The usual decrease is from four to three vials per day. It is important that the dosage be reduced gradually to avoid exacerbation of asthma. It is emphasized that in patients whose dosage has been titrated to fewer than four vials per day, an increase in the dose of cromolyn sodium inhalation solution, USP and the introduction of, or increase in, symptomatic medications may be needed if the patient's clinical condition deteriorates.
Corticosteroids
In patients chronically receiving corticosteroids for the management of bronchial asthma, the dosage should be maintained following the introduction of cromolyn sodium inhalation solution, USP. If the patient improves, an attempt to decrease corticosteroids should be made. Even if the corticosteroid-dependent patient fails to show symptomatic improvement following cromolyn sodium inhalation solution, USP administration, the potential to reduce corticosteroids may nonetheless be present. Thus, gradual tapering of corticosteroid dosage may be attempted. It is important that the dose be reduced slowly, maintaining close supervision of the patient to avoid an exacerbation of asthma.
It should be borne in mind that prolonged corticosteroid therapy frequently causes an impairment in the activity of the hypothalamic-pituitary-adrenal axis and a reduction in the size of the adrenal cortex. A potentially critical degree of impairment or insufficiency may persist asymptomatically for some time even after gradual discontinuation of adrenocortical steroids. Therefore, if a patient is subjected to significant stress, such as a severe asthmatic attack, surgery, trauma or severe illness while being treated or within one year (occasionally up to two years) after corticosteroid treatment has been terminated, consideration should be given to reinstituting corticosteroid therapy. When respiratory function is impaired, as may occur in severe exacerbation of asthma, a temporary increase in the amount of corticosteroids may be required to regain control of the patient's asthma.
It is particularly important that great care be exercised if, for any reason, cromolyn sodium inhalation solution, USP is withdrawn in cases where its use has permitted a reduction in the maintenance dose of corticosteroids. In such cases, continued close supervision of the patient is essential since there may be sudden reappearance of severe manifestations of asthma which will require immediate therapy and possible reintroduction of corticosteroids.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Cromolyn (inhalation) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cromolyn (inhalation) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Cromolyn (inhalation) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Cromolyn (inhalation) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cromolyn (inhalation) in pediatric patients.
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Cromolyn (inhalation) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Cromolyn (inhalation) in the drug label.
There is limited information regarding Pharmacodynamics of Cromolyn (inhalation) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Cromolyn (inhalation) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Cromolyn (inhalation) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Cromolyn (inhalation) in the drug label.
How Supplied
Cromolyn Sodium Inhalation Solution Unit-Dose 2 mL Vial is supplied as a colorless to pale yellow solution containing 20 mg cromolyn sodium, USP, in water for injection, USP, with 5 vials per foil pouch in cartons as listed below.
60 vials per carton. (NDC 0172-6406-49).
120 vials per carton. (NDC 0172-6406-59).
Each vial is made from a low density polyethylene (LDPE) resin.
Storage
Store at 20°-25°C (68°-77°F). Do not use if solution is discolored or contains a precipitate.
Images
Drug Images
{{#ask: Page Name::Cromolyn (inhalation)
|?Pill Name
|?Drug Name
|?Pill Ingred
|?Pill Imprint
|?Pill Dosage
|?Pill Color
|?Pill Shape
|?Pill Size (mm)
|?Pill Scoring
|?NDC
|?Drug Author
|format=template
|template=DrugPageImages
|mainlabel=-
|sort=Pill Name
}}
01.png){kind=link}