Dosing and uses of Cromolyn sodium inhaled
Adult dosage forms and strengths
nebulization solution
- 10mg/mL (2mL/vial)
Asthma
20 mg inhaled via nebulization QID; may decrease to BID/TID once stabilized
Bronchospasm Prophylaxis (Exercise Induced or Allergen)
Administer 20 mg as single dose 10-15 min prior to exercise or allergen exposure but no longer than 1 hr
Mastocytosis (Orphan)
Orphan designation for treatment of mastocytosis
Sponsor
- Patara Pharma, LLC; 11455 El Camino Real, Suite 460; San Diego, California 92130
Pediatric dosage forms and strengths
nebulization solution
- 10mg/mL (2mL/vial)
Asthma
<2 years: Safety and efficacy not established
≥2 years: 20 mg inhaled via nebulization QID; may decrease to BID/TID once stabilized
Bronchospasm Prophylaxis (Exercise Induced or Allergen)
<2 years: Safety and efficacy not established
&ge2 years: Administer 20 mg as single dose 10-15 min prior to exercise or allergen exposure but no longer than 1 hr
Cromolyn sodium inhaled adverse (side) effects
Frequency not defined
Cough
Flushing
Palpitation
Chest pain
Nasal congestion
Nausea
Fatigue
Migraine
Sneezing
Wheezing
Psychosis
Pruritus
Dysphagia
Esophagospasm
Pancytopenia
Polycythemia
Tinnitus
Pharyngitis
Lupus erythematosus
Warnings
Contraindications
Hypersensitivity; acute asthma attack
Cautions
Not for status asthmaticus
Use caution in patients with a history of cardiac arryhthmias
Use caution in renal or hepatic impairment; may require dose adjustment
Some reports of bronchospasm or cough after administration
Not useful in acute situations
Symptoms may reoccur while withdrawing or tapering the dose
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether distributed in breast milk; likely compatible
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Cromolyn sodium inhaled
Mechanism of action
Mast cell stabilizer; inhibits release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis from mast cell by inhibiting degranulation following exposure to reactive antigens
Pharmacokinetics
Absorption: 8%
Peak plasma time: 15 min
Peak plasma concentration: 9 ng/mL
Half-life: 80-90 min
Onset: 2-6 weeks (PO)
Duration: 6 hr
Excretion: Feces (98%, unabsorbed drugs); urine (<0.5%)
