CROMOPTIC
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CROMOPTIC (CROMOPTIC).
Mast cell stabilizer that inhibits the release of histamine and other inflammatory mediators from mast cells. Also inhibits eosinophil chemotaxis and activation.
| Metabolism | Not significantly metabolized; primarily excreted unchanged in urine and bile. |
| Excretion | Primarily renal excretion of unchanged drug (approximately 70% within 24 hours); the remainder is excreted in feces via biliary elimination (approximately 30%). |
| Half-life | 1.3 hours (terminal elimination half-life); clinically, due to rapid elimination, dosing is required 4 times daily for sustained effect. |
| Protein binding | Approximately 65% (primarily to albumin). |
| Volume of Distribution | 0.3–0.5 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Ophthalmic: negligible systemic bioavailability (<0.1%); oral: approximately 1% (low due to poor absorption and first-pass metabolism). |
| Onset of Action | Ophthalmic solution: within minutes (usually 5–10 minutes) for topical effect; oral: 1–2 hours. |
| Duration of Action | Ophthalmic solution: 4–6 hours (requires frequent dosing); oral: 6–8 hours. |
1-2 drops in each eye 4 times daily for conjunctivitis; 1 drop in each eye 2-4 times daily for allergic conjunctivitis prophylaxis.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No adjustment required; systemic absorption negligible. |
| Liver impairment | No adjustment required; systemic absorption negligible. |
| Pediatric use | Same as adult dosing for children ≥4 years; safety and efficacy not established in children <4 years. |
| Geriatric use | No specific 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 CROMOPTIC (CROMOPTIC).
| Breastfeeding | It is unknown if cromolyn sodium is excreted in human breast milk. Due to limited data and low systemic absorption after ophthalmic administration, risk to nursing infant is likely minimal. M/P ratio is not established. |
| Teratogenic Risk | Cromolyn sodium (CROMOPTIC) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects. No adequate and well-controlled studies exist in pregnant women. Potential risk to fetus is considered low, but use only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to cromolyn sodium or any component of the formulation"]
| Precautions | ["For ophthalmic use only; not for injection or intraocular use.","May cause transient stinging or burning upon instillation.","Patients should remove contact lenses before use and wait 10-15 minutes before reinsertion.","Do not use if solution becomes cloudy or contains sediment."] |
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| Fetal Monitoring |
| No specific monitoring required beyond standard prenatal care. Monitor for maternal ocular adverse effects and for any systemic effects if administered at high doses. |
| Fertility Effects | No known adverse effects on fertility in animal studies. Human data are lacking, but given low systemic absorption, significant impact on fertility is unlikely. |