ALOCRIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALOCRIL (ALOCRIL).
Mast cell stabilizer that inhibits the release of inflammatory mediators (e.g., histamine, leukotrienes) from conjunctival mast cells. Also inhibits eosinophil chemotaxis and activation.
| Metabolism | Negligible systemic absorption; not extensively metabolized. Any absorbed drug undergoes hepatic metabolism via unknown pathways. |
| Excretion | Renal (primarily unchanged drug; approximately 50-60% excreted unchanged in urine within 48 hours). Biliary/fecal elimination accounts for <10%. |
| Half-life | 8.6 hours (terminal elimination half-life in healthy adults; may be prolonged in renal impairment, e.g., up to 18 hours in patients with severe renal dysfunction). |
| Protein binding | Approximately 90% (primarily to serum albumin). |
| Volume of Distribution | 0.3 L/kg (low distribution primarily within extracellular fluid; limited tissue penetration). |
| Bioavailability | Ophthalmic route: Systemic bioavailability is minimal (<2% due to local ocular administration and nasolacrimal drainage). |
| Onset of Action | Ophthalmic route: 2-3 minutes after instillation (onset of reduction in conjunctival itching in allergic conjunctivitis). |
| Duration of Action | Up to 8 hours (clinical effect: prevention of itching associated with allergic conjunctivitis; recommended dosing is twice daily). |
2 drops in each eye four times daily; ophthalmic route.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy not established in children under 4 years. |
| Geriatric use | No specific dose adjustment recommended. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALOCRIL (ALOCRIL).
| Breastfeeding | Unknown if excreted in human milk. Not recommended during breastfeeding due to potential ocular effects in infant. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies. Insufficient human data; avoid use in first trimester unless clearly necessary. |
| Fetal Monitoring | No specific monitoring required beyond standard pregnancy care. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to nedocromil or any component of the formulation"]
| Precautions | ["Not for treatment of contact lens-related irritation; remove lenses before instillation and wait 10 minutes before reinserting","Contains benzalkonium chloride, which may be absorbed by soft contact lenses","Do not touch dropper tip to any surface to avoid contamination","May cause transient stinging or burning upon instillation"] |
| Food/Dietary | None known. No food interactions reported for ophthalmic nedocromil. However, avoid rubbing eyes after application to prevent contamination or irritation. |
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| Fertility Effects | No known adverse effects on fertility in animal studies. |
| Clinical Pearls |
| Alocril (nedocromil sodium ophthalmic solution) is a mast cell stabilizer indicated for the treatment of itching associated with allergic conjunctivitis. Onset of action may require several days to weeks of regular use. For optimal effect, instruct patients to continue use even during symptom-free periods. Do not administer while wearing contact lenses; remove lenses before instillation and wait at least 10-15 minutes before reinserting. Not effective for acute symptom relief; consider adjunct use with antihistamines for immediate relief. |
| Patient Advice | Use exactly as prescribed; do not skip doses or stop without consulting your doctor. · Wash hands before each use. Tilt head back, pull down lower eyelid, and instill one drop into the affected eye(s). · Do not touch the dropper tip to any surface, including your eye, to avoid contamination. · Contact lenses must be removed before instillation and can be reinserted after 10-15 minutes. · It may take several days to weeks of regular use to feel full benefit; continue use even if symptoms improve. · If you miss a dose, use it as soon as you remember, unless it is almost time for the next dose. Do not double doses. · Store at room temperature, away from heat and moisture. Keep bottle tightly closed when not in use. · Report any eye pain, vision changes, or worsening symptoms to your healthcare provider. |