NASALCROM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NASALCROM (NASALCROM).
Cromolyn sodium stabilizes mast cells by inhibiting the release of histamine and other mediators of inflammation from sensitized mast cells. The exact molecular mechanism is not fully understood but may involve inhibition of calcium ion influx into mast cells.
| Metabolism | Not metabolized; excreted unchanged in urine and bile. |
| Excretion | Primarily unchanged drug; renal excretion accounts for ~90% of elimination, with minor biliary/fecal excretion (<5%). |
| Half-life | Terminal elimination half-life is 1-2 hours; clinically, due to local mast cell stabilization, systemic levels do not correlate with effect. |
| Protein binding | ~65% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Vd is approximately 0.2 L/kg, indicating limited distribution to tissues; primarily remains in extracellular fluid. |
| Bioavailability | Intranasal: bioavailability is approximately 1% (7% with concurrent rhinitis); negligible systemic absorption. |
| Onset of Action | Intranasal: 2-4 weeks of regular use for prophylactic effect; no immediate relief for acute symptoms. |
| Duration of Action | Duration of clinical effect is sustained with regular dosing (every 6-8 hours); protective effect on mast cells lasts hours after local absorption. |
One spray (5.2 mg) into each nostril 3-4 times daily (maximum 6 times daily).
| Dosage form | SPRAY, METERED |
| Renal impairment | No adjustment required; nasal cromolyn has negligible systemic absorption. |
| Liver impairment | No adjustment required; nasal cromolyn undergoes minimal hepatic metabolism. |
| Pediatric use | Children 2 years and older: One spray (5.2 mg) into each nostril 3-4 times daily. |
| Geriatric use | No specific dose adjustment; use same as adult dosing. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NASALCROM (NASALCROM).
| Breastfeeding | Cromolyn sodium is excreted in human breast milk in low concentrations. The milk-to-plasma ratio is unknown. The American Academy of Pediatrics classifies it as compatible with breastfeeding. Because of low systemic absorption after intranasal use, amounts ingested by infant are likely minimal. |
| Teratogenic Risk | Pregnancy Category B. In animal studies, cromolyn sodium showed no teratogenic effects at doses up to 338 times the human dose. There are no adequate and well-controlled studies in pregnant women. Risk to fetus in first trimester is considered low based on animal data and limited human experience. No specific fetal risks identified in second or third trimester. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to cromolyn sodium or any component of the formulation.
| Precautions | May cause bronchospasm on inhalation, especially in patients with asthma. Discontinue if severe hypersensitivity reactions occur. Renal impairment may require dose adjustment. |
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| Fetal Monitoring | No specific monitoring required beyond routine prenatal care. For patients with allergic rhinitis or asthma, monitor maternal symptoms and pulmonary function as clinically indicated. |
| Fertility Effects | No adverse effects on fertility noted in animal studies. No human data on fertility impairment. Cromolyn sodium is not known to affect reproductive function. |