Nedocromil is a mast cell stabilizer. It is available as an ophthalmic solution for the treatment of allergic conjunctivitis in adult and pediatric patients. Nedocromil ophthalmic solution is approved in patients 3 years and older.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-For ophthalmic use only.
-Wash hands before and after use.
-Tilt the patient's head back slightly and pull the lower eyelid down with the index finger. Squeeze the prescribed number of drops into the conjunctival sac. Have the patient blink a few times to spread the solution. Have patients close eye and remove any excess solution with a clean tissue. Repeat in the other eye.
-Avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surfaces.
-To avoid the spread of infection, do not use a dropper for more than one person.
In general, nedocromil is well tolerated. Adverse effects usually are limited to the site of application.
In trials with nedocromil ophthalmic solution, headache was the most frequently reported adverse event in approximately 40% of patients.
In trials with nedocromil ophthalmic solution, ocular burning, ocular irritation and ocular stinging were reported in 10% to 30% of patients. Conjunctivitis, eye redness, and photophobia were reported in 1% to 10%. Of note, some of these ophthalmic adverse events were similar to the underlying disease being studied.
In trials with nedocromil ophthalmic solution, unpleasant taste (dysgeusia) and nasal congestion were reported in 10% to 30% of patients. Asthma and rhinitis were reported in 1% to 10%.
Nedocromil is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
The manufacturer recommends administering nedocromil during pregnancy only if clearly needed. Adequate and well controlled studies in pregnant women have not been done. Animal data suggests that nedocromil crosses the placenta but does not cause fetal harm.
After ocular administration of nedocromil, less than 4% of the total dose of a 2% solution was systemically absorbed; it is unlikely that a nursing infant would be exposed to clinically significant amounts of the drug during breast-feeding. Nedocromil is distributed into breast milk of lactating rats when administered intravenously, but excretion into human milk is not certain. According to the manufacturer, nedocromil should be used cautiously in lactating women.
The safety and efficacy of nedocromil sodium for ophthalmic use have not been established in neonates, infants, or children less than 3 years of age.
Users of contact lenses should generally refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis. Nedocromil sodium for ophthalmic use contains benzalkonium chloride as a preservative, and wearers of soft contact lenses should be advised against using the lenses during therapy. Benzalkonium chloride can be absorbed by soft contact lenses.
For the treatment of ocular pruritus related to allergic ocular disorders such as allergic conjunctivitis:
Ophthalmic dosage (2% ophthalmic solution):
Adults: 1 to 2 drops in each eye twice daily.
Children and Adolescents 3 to 17 years: 1 to 2 drops in each eye twice daily.
Maximum Dosage Limits:
-Adults
4 ophthalmic drops/day per eye.
-Geriatric
4 ophthalmic drops/day per eye.
-Adolescents
4 ophthalmic drops/day per eye.
-Children
3 years and older: 4 ophthalmic drops/day per eye.
Less than 3 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Nedocromil products.
Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated. In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal subtype and inhibits beta-glucuronidase release from macrophages. In the eye, the drug reduces ocular itching due to allergies.
Nedocromil is administered via ocular administration topically to the eye. Nedocromil is not metabolized and any absorbed drug is eliminated unchanged in the urine (70%) and feces (30%).
-Route-Specific Pharmacokinetics
Other Route(s)
Ophthalmic Route
After ocular administration of nedocromil, less than 4% of the total dose of a 2% solution was systemically absorbed; absorption is mainly through the nasolacrimal duct.