cromolyn sodium

Brand: Intal (inhaled — discontinued US market), NasalCrom (nasal), Gastrocrom (oral)

Prototype Drug
Drug Class: mast cell stabilizer
Drug Family: mast cell stabilizer
Subclass: chromone anti-inflammatory agent
Organ Systems: respiratoryimmunology

Mechanism of Action

Stabilizes mast cell membranes by inhibiting calcium influx through chloride channels, preventing degranulation and the release of mediators (histamine, leukotrienes, prostaglandins) in response to allergen exposure; mechanism is purely preventive — has no bronchodilatory or anti-inflammatory effect after mast cell degranulation has occurred.

mast cell chloride channelscalcium influx in mast cells

Indications

  • prophylaxis of allergic asthma (particularly exercise-induced and allergen-triggered)
  • prophylaxis of allergic rhinitis (nasal spray)
  • mastocytosis and food allergy-associated GI symptoms (oral capsules)

Contraindications

  • acute bronchospasm (not a bronchodilator)
  • status asthmaticus
  • hypersensitivity

Adverse Effects

Common

  • bronchospasm (from inhaled powder — requires pre-medication with bronchodilator)
  • cough
  • throat irritation
  • sneezing (nasal)
  • nausea (oral)

Serious

  • rare anaphylaxis
  • pulmonary infiltrates with eosinophilia (rare)

Pharmacokinetics (ADME)

Absorption inhaled: approximately 8% systemic absorption; nasal: minimal; oral: <1% absorbed
Distribution confined to airway mucosa and local tissue
Metabolism not metabolized; excreted unchanged
Excretion equal renal and biliary excretion of absorbed drug; unabsorbed oral drug excreted in feces
Half-life approximately 80-90 minutes
Onset preventive effect requires consistent use for 2-4 weeks; no acute effect
Peak 15 minutes post-inhalation
Duration requires 3-4 times daily dosing for prevention
Protein Binding minimal
Vd small (confined to airway)

Drug Interactions

Drug / Agent Mechanism Severity
no significant drug interactions not metabolized; not a CYP substrate; very limited systemic absorption minor

Nursing Considerations

  1. Cromolyn is strictly preventive — it has no role in treating acute bronchospasm; patients must understand that it will not provide immediate relief and should continue using their rescue SABA for acute symptoms.
  2. Effective prophylaxis requires consistent dosing 3-4 times daily for both asthma and rhinitis; full preventive benefit may not be apparent for 2-4 weeks of regular use.
  3. For exercise-induced asthma prophylaxis, instruct patient to inhale cromolyn 10-15 minutes before exercise; this pre-exercise dosing must be timed correctly to achieve adequate mast cell stabilization at the time of exercise.
  4. The inhaled powder formulation can paradoxically cause bronchospasm in some patients; pretreatment with a SABA 15 minutes before cromolyn inhalation may prevent this effect.

Clinical Pearls

  • Cromolyn sodium was a mainstay of asthma prevention therapy in the 1970s-1990s before ICS became dominant; it is now rarely used in asthma management because ICS are superior in efficacy and require less frequent dosing, but cromolyn remains useful in specific contexts (exercise-induced asthma, pediatric preference, pregnancy).
  • Oral cromolyn sodium (Gastrocrom) for mastocytosis and food allergy-associated GI symptoms is unique — the drug is virtually unabsorbed when taken orally, acting entirely within the GI lumen to stabilize mucosal mast cells without any systemic effect.

Safety Profile

Pregnancy safe
Lactation use-with-caution
Renal Adjustment Not required
Hepatic Adjustment Not required
TDM Not required