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Cromolyn (sodium cromoglicate) (oral inhalation): Drug information

Cromolyn (sodium cromoglicate) (oral inhalation): Drug information
(For additional information see "Cromolyn (sodium cromoglicate) (oral inhalation): Patient drug information" and see "Cromolyn (sodium cromoglicate) (oral inhalation): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • PMS-Sodium Cromoglycate [DSC]
Pharmacologic Category
  • Mast Cell Stabilizer
Dosing: Adult
Asthma, maintenance therapy

Asthma, maintenance therapy:

Note: Routine use of cromolyn for asthma is not recommended due to lower efficacy relative to other therapies (GINA 2023).

Nebulization solution: Initial: 20 mg 4 times daily; must be used at regular intervals for 2 to 4 weeks to be effective. Note: Once control is achieved, may taper frequency gradually to the lowest effective dose (eg, 4 times daily, then 3 times daily).

Exercise- or allergen-induced bronchospasm, prevention

Exercise- or allergen-induced bronchospasm, prevention:

Note: Regular maintenance/controller therapy with inhaled corticosteroids or combination as-needed short-acting beta agonist and corticosteroid is preferred (GINA 2023).

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

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Cromolyn (sodium cromoglicate) (oral inhalation): Pediatric drug information")

Asthma, maintenance therapy

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

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

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

Contraindications

Hypersensitivity to cromolyn or any component of the formulation

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.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Pricing: US

Nebulization (Cromolyn Sodium Inhalation)

20 mg/2 mL (per mL): $2.50 - $10.85

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Nebulization Solution, Inhalation, as sodium:

Generic: 20 mg/2 mL ([DSC])

Administration: Adult

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.

Administration: Pediatric

Oral inhalation: 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.

Use: Labeled Indications

Asthma: Maintenance and prophylactic therapy for asthma.

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

Note: Although included as an FDA-approved use in the manufacturer’s prescribing information for the treatment of asthma, routine use is not recommended due to lower efficacy relative to other therapies (GINA 2023).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

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 2023).

Agents other than cromolyn are preferred for the control of asthma in pregnancy (GINA 2023).

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 patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

It is not known if cromolyn is present in breast milk.

The manufacturer recommends caution be used if administered to breastfeeding patients. The World Health Organization considers cromolyn to be compatible with breastfeeding (WHO 2002).

Monitoring Parameters

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

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Absorption:

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

Oral: <1% of dose absorbed

Half-life elimination: 80 to 90 minutes

Time to peak, serum: Inhalation: ~15 minutes

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

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  3. Burchett DK, Darko W, Zahra J, Noviasky J, Probst L, Smith A. Mixing and compatibility guide for commonly used aerosolized medications. Am J Health Syst Pharm. 2010;67(3):227-230. doi:10.2146/ajhp080261 [PubMed 20101066]
  4. Cromolyn Sodium inhalation solution [prescribing information]. Locust Valley, NY: Fera Pharmaceuticals LLC; August 2020.
  5. Expert Panel Report 3. Guidelines for the Diagnosis and Management of Asthma. Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 08-4051, prepublication 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm
  6. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf. Updated 2020. Accessed May 6, 2020.
  7. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/2023-gina-main-report/. Updated 2023. Accessed August 23, 2023.
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  10. Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2):1901208. doi:10.1183/13993003.01208-2019 [PubMed 31699837]
  11. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. NIH Publication No. 08-4051. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute; 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Accessed June 22, 2015.
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  13. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. https://apps.who.int/iris/handle/10665/62435.
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