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Cromolyn (Oral Inhalation)

Medically reviewed by Drugs.com. Last updated on Mar 4, 2020.

Pronunciation

(KROE moe lin)

Index Terms

  • Cromoglicate
  • Cromoglycic Acid
  • Cromolyn Sodium
  • Disodium Cromoglycate
  • DSCG
  • Intal
  • Sodium Cromoglicate
  • Sodium Cromoglycate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Nebulization Solution, Inhalation, as sodium:

Generic: 20 mg/2 mL (2 mL)

Nebulization Solution, Inhalation, as sodium [preservative free]:

Generic: 20 mg/2 mL (2 mL)

Pharmacologic Category

  • Mast Cell Stabilizer

Pharmacology

Prevents the mast cell release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis by inhibiting degranulation after contact with antigens

Absorption

Inhalation: ~8% reaches lungs upon inhalation; well absorbed

Excretion

Equally excreted unchanged in urine and feces (via bile); after inhalation, small amounts are exhaled

Time to Peak

Serum: Inhalation: ~15 minutes

Half-Life Elimination

80 to 90 minutes

Use: Labeled Indications

Note: Current expert recommendations do not recommend cromolyn for routine use for asthma, due to lower efficacy relative to other therapies (GINA 2019). Cromolyn may be considered for exercise-induced bronchospasm; however, regular controller therapy with inhaled corticosteroids or combination as-needed short-acting beta agonist and corticosteroids is preferred (GINA 2019).

Asthma: Maintenance and prophylactic therapy for asthma.

Exercise- or allergen-induced bronchospasm, prevention: Prevention of exercise- or allergen-induced bronchospasm.

Contraindications

Hypersensitivity to cromolyn or any component of the formulation

Dosing: Adult

Asthma:

Note: Current expert recommendations do not recommend cromolyn for routine use for asthma due to lower efficacy relative to other therapies (GINA 2020).

Nebulization solution: Initial: 20 mg 4 times daily; must be used at regular intervals for 2 to 4 weeks to be effective. Note: If concomitant medications are eliminated or required on a prn basis, may taper frequency to the lowest effective dose (eg, 4 times daily, then 3 times daily, then twice daily). If clinical deterioration or symptoms occur or there is an increase need for concomitant medications, increase frequency to 4 times daily.

Exercise- or allergen-induced bronchospasm, prevention:

Note: Cromolyn may be considered for exercise-induced bronchospasm; however, regular controller therapy with inhaled corticosteroids or combination as-needed short-acting beta agonist and corticosteroid is preferred (GINA 2020).

Nebulization solution: 20 mg as a single dose; administer 10 to 15 minutes prior to exercise or allergen exposure.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Asthma, maintenance therapy:

Note: Due to lower efficacy relative to other therapies, current expert recommendations do not recommend cromolyn for either initial treatment of persistent asthma in children or routine use (GINA 2020; NAEPP 2007); cromolyn is considered an alternative medication for the treatment of mild persistent asthma in children (NAEPP 2007).

Children ≥2 years and Adolescents: Nebulization solution: Initial: 20 mg 4 times daily; usual dose: 20 mg 3 to 4 times daily; must be used at regular intervals for 2 to 4 weeks to be effective. Note: Once control is achieved, taper frequency to the lowest effective dose (eg, 4 times daily to 3 times daily to twice daily).

Exercise- or allergen-induced bronchospasm; prevention:

Note: Cromolyn may be considered for exercise-induced bronchospasm; however, regular controller therapy with inhaled corticosteroids or combination as-needed short-acting beta agonist and corticosteroids is preferred (AAAAI/ACAAI [Weiler 2016]; GINA 2020).

Children ≥2 years and Adolescents: Nebulization solution: 20 mg as a single dose; Note: Administer 10 to 15 minutes prior to exercise or allergen exposure but no longer than 1 hour before.

Administration

Oral inhalation: Nebulization solution: Squeeze contents of the unit-dose vial into the solution container of nebulizer. Nebulization should take approximately 5 to 10 minutes. Compatibility with other medications (eg, albuterol, budesonide) in nebulizer has been reported (Burchett 2010; Kamin 2014); also refer to institution-specific policies.

Storage

Store at room temperature of 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not always defined.

Central nervous system: Drowsiness

Dermatologic: Burning sensation of the nose, pruritus of nose

Gastrointestinal: Nausea, stomach pain

Hypersensitivity: Serum sickness

Respiratory: Cough (20%; transient), wheezing (4%; mild), epistaxis, nasal congestion, sneezing

<1%, postmarketing, and/or case reports: Anaphylaxis, anemia, angioedema, arthralgia, bronchospasm, dizziness, dysuria, exfoliative dermatitis, headache, hemoptysis, hoarseness, joint swelling, lacrimation, laryngeal edema, nephrosis, myalgia, parotid gland enlargement, pericarditis, peripheral neuritis, photodermatitis, polymyositis, pulmonary infiltrates (with eosinophilia), skin rash, urinary frequency, urticaria, vasculitis (periarteritis), vertigo

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Severe anaphylactic reactions may occur rarely

• Bronchospasm: May occur with cough after inhalation; if this occurs, treat with a fast-acting bronchodilator.

Disease-related concerns:

• Asthma: Not to be used in the treatment of status asthmaticus.

Other warnings/precautions:

• Withdrawal: Caution should be used when withdrawing the drug or tapering the dose as symptoms may reoccur.

Monitoring Parameters

FEV1, peak flow meter and/or other pulmonary function tests; asthma symptoms.

Pregnancy Risk Factor

B

Pregnancy Considerations

Limited data suggest little or no placental transfer (Brogden 1974).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2020).

Other agents are preferred for the control of asthma in pregnancy (GINA 2020).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant females in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Patient Education

What is this drug used for?

• It is used to treat asthma.

• It is used to prevent breathing problems that happen with exercise.

• Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Cough

• Stuffy nose

• Nausea

• Sneezing

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Trouble breathing

• Persistent cough

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.