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.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Cromolyn (sodium cromoglicate) (oral inhalation): Drug information")
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.
There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
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)
Yes
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)
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.
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.
Store at room temperature of 15°C to 30°C (59°F to 86°F). Protect from light.
Prophylactic agent used for long-term (chronic) control of persistent asthma; the prevention of allergen- or exercise-induced bronchospasm (All indications: FDA approved in ages ≥2 years and adults).
Note: Current expert recommendations do not recommend cromolyn for routine use for asthma, due to lower efficacy relative to other therapies (GINA 2020). 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).
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
Hypersensitivity to cromolyn or any component of the formulation
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.
None known.
There are no known significant interactions.
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.
Asthma: Periodic pulmonary function tests; signs and symptoms of disease state when tapering dose.
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
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
Nebulization (Cromolyn Sodium Inhalation)
20 mg/2 mL (per mL): $3.40 - $10.85
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