NEDOCROMIL SODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEDOCROMIL SODIUM (NEDOCROMIL SODIUM).
Nedocromil sodium is a mast cell stabilizer that inhibits the release of inflammatory mediators (e.g., histamine, leukotrienes) from mast cells and other inflammatory cells. It also reduces sensory nerve activation and inhibits eosinophil chemotaxis.
| Metabolism | Primarily excreted unchanged in urine and feces. Minimal hepatic metabolism; no major CYP450 involvement. |
| Excretion | Primarily renal excretion of unchanged drug; approximately 70% excreted in urine and 30% in feces via biliary elimination. |
| Half-life | Terminal elimination half-life is approximately 2 hours; clinically, this supports twice-daily dosing for sustained effect. |
| Protein binding | Approximately 95% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.5-0.6 L/kg, indicating limited extravascular distribution. |
| Bioavailability | Oral bioavailability is less than 5% due to poor absorption; inhalation delivers drug directly to lungs, with systemic absorption approximately 10-15% of inhaled dose. |
| Onset of Action | Inhalation: clinical effect observed within 1-2 weeks of regular use; not for acute bronchospasm relief. |
| Duration of Action | Duration of anti-inflammatory effect persists for several hours after dosing; requires regular twice-daily administration for continuous benefit. |
2 inhalations (2 mg per inhalation) four times daily via metered-dose inhaler, or 2 inhalations (4 mg per inhalation) twice daily via dry powder inhaler.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required; nedocromil sodium is not significantly renally eliminated. |
| Liver impairment | No dose adjustment required for hepatic impairment; nedocromil sodium undergoes minimal hepatic metabolism. |
| Pediatric use | Children 6 years and older: same as adult dosing; safety and efficacy not established in children under 6 years. |
| Geriatric use | No specific dose adjustment; use with caution due to potential age-related decrease in pulmonary function and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEDOCROMIL SODIUM (NEDOCROMIL SODIUM).
| Breastfeeding | Minimal excretion into breast milk (M/P ratio unknown). Considered compatible with breastfeeding; use with caution in preterm or low-birth-weight infants. |
| Teratogenic Risk | Category B. No evidence of teratogenicity in animal studies; no adequate human studies. Theoretical risk of fetal harm low. First trimester: minimal risk; second trimester: minimal risk; third trimester: minimal risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to nedocromil sodium or any component of the formulation.","Acute asthma exacerbation or status asthmaticus (not for rescue use)."]
| Precautions | ["Not for treatment of acute bronchospasm or status asthmaticus.","May cause bronchospasm or cough upon inhalation; discontinue if paradoxical bronchospasm occurs.","Rare hypersensitivity reactions including angioedema and urticaria.","Monitor for worsening asthma; adjust therapy if needed.","Use with caution in patients with severe hepatic or renal impairment (limited data)."] |
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| No specific monitoring required beyond standard obstetric care. Monitor for maternal respiratory status and fetal growth. |
| Fertility Effects | No reported adverse effects on human fertility based on limited data. No impairment in animal studies. |