Cromolyn
INTAL
Pronunciation: KROE-moe-lin
What it isMast-cell stabilizer; prophylaxis for asthma and allergy, and symptom control in mastocytosis.
Why this oneMinimal systemic absorption gives it an unusually clean safety profile when local prophylaxis is enough.
What limits itIt does nothing for an acute attack and frequent dosing undermines adherence. Inhalation can provoke cough or bronchospasm.
FDA-approved for
- asthma/allergy (~1973)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Bronchial asthma (prophylaxis, maintenance) | Adults | 1 vial (20 mg/2 mL) nebulized QID | 1 vial nebulized QID | Undefined |
| Prevention of exercise-/cold air-/allergen-induced bronchospasm | Adults | 1 vial (20 mg) nebulized once shortly before exposure | Same | Undefined |
| Bronchial asthma (prophylaxis, maintenance) | Children ≥2 yr | 1 vial (20 mg/2 mL) nebulized QID | 1 vial nebulized QID | Undefined |
| Prevention of exercise-/cold air-/allergen-induced bronchospasm | Children ≥2 yr | 1 vial (20 mg) nebulized once shortly before exposure | Same | Undefined |
Renal Undefined
Hepatic Undefined
Response usually within 2–4 weeks; add to existing regimen, then taper concomitant drugs/steroids slowly.
Instructions
- Nebulize at regular intervals; not effective if swallowed
- Do not mix with other drugs in nebulizer (stability/safety not established)
- Start once acute episode controlled, airway cleared, and patient can inhale adequately
- Reduce gradually (usual decrease from 4 to 3 vials/day) to avoid asthma exacerbation
Available strengths
- sol 100 mg/5 mL
- sol 10 mg/mL
- drops 4 %
- nasal spray 5.2 mg/spray
Cautions
- No role in status asthmaticus
- Anaphylactic reactions (rare)
Adverse reactions
- Cough
- Nasal congestion
- Nausea
- Sneezing
- Wheezing
Pregnancy Category B: no fetal malformations in animal studies; no adequate human studies — use only if clearly needed.
Lactation Unknown whether excreted in human milk; use caution in nursing women.
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 100 mg/5 mL | sol | per unit | $0.35/mL | not offered |
| 10 mg/mL | sol | per unit | not offered |
Generic entry1994
NO BOXED WARNINGS
Principal riskProphylaxis only; four-times-daily dosing
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.