GASTROCROM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GASTROCROM (GASTROCROM).
Mast cell stabilizer; inhibits degranulation of mast cells and release of histamine and other inflammatory mediators.
| Metabolism | Not metabolized; excreted unchanged in urine and bile. |
| Excretion | Primarily excreted unchanged in bile and feces via enterohepatic circulation; renal excretion accounts for approximately 1-2% of an oral dose. After intravenous administration, about 50% is excreted unchanged in urine within 48 hours. |
| Half-life | Terminal elimination half-life is approximately 1–1.5 hours following intravenous administration. The apparent half-life after oral inhalation is longer due to slow absorption from the lungs, but systemic half-life remains short, requiring frequent dosing for sustained effect. |
| Protein binding | Approximately 65% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | 0.2–0.4 L/kg, indicating distribution mainly within extracellular fluid. Low Vd suggests limited tissue penetration, consistent with its poor oral bioavailability and action at mucosal surfaces. |
| Bioavailability | Oral: <1% due to poor absorption; Inhalation: ~8% (systemic absorption from lung); Ophthalmic: minimal systemic absorption (<0.5%). |
| Onset of Action | Inhalation (nebulizer): 15–30 minutes; Oral: Not applicable for acute effects as it is not significantly absorbed; Ophthalmic: relief within minutes for allergic conjunctivitis. |
| Duration of Action | Inhalation: 4–6 hours after a single dose; requires administration 4 times daily for maintenance. Ophthalmic: up to 4–6 hours. Duration limited by rapid elimination and need for continuous presence at site of action. |
200 mg orally four times daily, 30 minutes before meals and at bedtime.
| Dosage form | CAPSULE |
| Renal impairment | No specific dose adjustment guidelines are available; use with caution in severe renal impairment. |
| Liver impairment | No specific dose adjustment guidelines are available; use with caution in severe hepatic impairment. |
| Pediatric use | Children 2-12 years: 100 mg orally four times daily. Children <2 years: not recommended. |
| Geriatric use | No specific dose adjustment; use with caution due to potential for decreased renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GASTROCROM (GASTROCROM).
| Breastfeeding | Excreted in human breast milk in small amounts (M/P ratio unknown). Considered compatible with breastfeeding due to poor oral absorption (<1%) in infants. Caution advised in preterm or neonates with impaired renal function. |
| Teratogenic Risk | FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, and no adequate human studies exist. Crosses placenta minimally. No known teratogenic effects in first trimester. Risk cannot be excluded in second and third trimesters due to lack of human data. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to cromolyn sodium or any component","Acute asthma attacks"]
| Precautions | ["May cause bronchospasm, cough, or wheezing upon inhalation","Should not be used for acute asthma attacks","Renal impairment may require dose adjustment","Rare: eosinophilic pneumonia, angioedema"] |
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| Fetal Monitoring |
| Monitor maternal respiratory status for bronchospasm or anaphylaxis. No specific fetal monitoring required. Observe for maternal hypersensitivity reactions. |
| Fertility Effects | No known effects on human fertility. In animal studies, no impairment of fertility was observed at doses up to 100 mg/kg. |