INTAL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INTAL (INTAL).
Mast cell stabilizer; inhibits degranulation of sensitized mast cells by blocking release of histamine and other inflammatory mediators.
| Metabolism | Not metabolized; excreted unchanged in urine and bile. |
| Excretion | Primarily renal: unchanged drug (50-70%) and conjugated metabolites (20-30%); biliary/fecal: <5%. |
| Half-life | Terminal elimination half-life: 1.5-2 hours in plasma; clinical effect persists longer due to mast cell stabilization in airways. |
| Protein binding | 55-65% bound, primarily to albumin. |
| Volume of Distribution | 0.8-1.2 L/kg; indicates distribution into total body water. |
| Bioavailability | Inhalation: ~8% (swallowed portion minimal absorption); oral: 1-4% due to poor gastrointestinal absorption and first-pass metabolism. |
| Onset of Action | Inhalation: 30-60 minutes (peak effect); oral: 2-4 hours. |
| Duration of Action | Inhalation: 4-6 hours; requires dosing 4 times daily for continuous effect. |
2 inhalations (2 mg each) via nebulizer 4 times daily; or 20 mg via inhalation powder (Spinhaler) 4 times daily.
| Dosage form | CAPSULE |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No specific dosage adjustment recommended for hepatic impairment; use caution in severe hepatic disease. |
| Pediatric use | Children 5-12 years: 2 inhalations (2 mg each) via nebulizer 4 times daily; or 20 mg via inhalation powder (Spinhaler) 4 times daily. Children 2-5 years: 2 inhalations (2 mg each) via nebulizer 4 times daily. |
| Geriatric use | No specific dosage adjustment required; monitor for renal function and potential side effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INTAL (INTAL).
| Breastfeeding | Cromolyn sodium (Intal) is excreted in human milk in low concentrations; M/P ratio not determined. Caution advised due to potential for adverse effects in nursing infants. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies; no adequate well-controlled studies in pregnant women. Not known to cause fetal harm; use only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to cromolyn sodium or any component of the formulation.
| Precautions | May cause bronchospasm, cough, or wheezing upon inhalation; discontinue if paradoxical bronchospasm occurs. Use with caution in patients with hepatic or renal impairment. Avoid abrupt withdrawal. |
| Food/Dietary | No significant food interactions known. Cromolyn sodium is poorly absorbed orally; food does not affect its topical or inhaled activity. However, avoid taking with acidic beverages (e.g., fruit juices) if using oral solution, as they may degrade the drug. |
| Clinical Pearls |
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| No specific monitoring required; standard prenatal care. Observe for maternal adverse effects (e.g., bronchospasm, cough). |
| Fertility Effects | No reported adverse effects on fertility in animal studies; human data insufficient. |
| Intal (cromolyn sodium) is a mast cell stabilizer used for prophylaxis of asthma and allergic rhinitis. It is not effective for acute bronchospasm. Requires regular use (3-4 times daily) for optimal effect. Onset of benefit may take 2-4 weeks. Administer via nebulizer for asthma; ensure proper cleaning of device. Monitor for paradoxical bronchospasm; if occurs, discontinue and use alternative therapy. Avoid in patients with known hypersensitivity to cromolyn. |
| Patient Advice | Use Intal regularly as prescribed; it does not relieve sudden asthma attacks. · Do not stop taking suddenly; taper under doctor's guidance. · For inhaler, shake well before use and follow proper inhalation technique. · Rinse mouth after use to prevent throat irritation. · Store at room temperature away from moisture and heat. · Report any worsening of asthma symptoms or new side effects. |