Alocril

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Alocril

Classes

Ocular Anti-Allergics, Mast Cell Stabilizers
Respiratory Mast Cell Stabilizers

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.

Adverse Reactions
Moderate

conjunctivitis / Delayed / 10.0-30.0
photophobia / Early / 1.0-10.0

Mild

headache / Early / 40.0-40.0
ocular irritation / Rapid / 10.0-30.0
nasal congestion / Early / 10.0-30.0
dysgeusia / Early / 10.0-30.0
rhinitis / Early / 1.0-10.0

Common Brand Names

Alocril

Dea Class

Rx

Description

Mast cell stabilizer
Used for allergic conjunctivitis in adult and pediatric patients 3 years and older

Dosage And Indications
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.

Dosing Considerations
Hepatic Impairment

No dosage adjustments are needed.

Renal Impairment

No dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Nedocromil products.

How Supplied

Alocril Ophthalmic Sol: 2%

Maximum Dosage
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.

Mechanism Of Action

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.

Pharmacokinetics

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%).

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.

Pregnancy And Lactation
Pregnancy

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.