Nedocromil (EENT)

Class: Antiallergic Agents
- Mast-cell Stabilizers
Chemical Name: 9-Ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4H-pyrano[3,2-g]quinoline-2,8-dicarboxylic acid
Molecular Formula: C₁₉H₁₇NO₇
CAS Number: 69409-73-6
Brands: Alocril

Medically reviewed by Drugs.com on Aug 23, 2021. Written by ASHP.

Introduction

Mast-cell stabilizer.

Uses for Nedocromil (EENT)

Allergic Conjunctivitis

Symptomatic treatment of ocular itching associated with allergic conjunctivitis.

Nedocromil (EENT) Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution. Administer at regular intervals.

If more than 1 topical ophthalmic drug is used, administer the drugs at least 10–15 minutes apart.

Avoid contamination of the solution container.

Continue therapy throughout period of exposure (i.e., until pollen season is over or until exposure to offending allergen is terminated), even in absence of symptoms.

Dosage

Available as nedocromil sodium; dosage expressed in terms of the salt.

Pediatric Patients

Allergic Conjunctivitis

Ophthalmic

Children ≥3 years of age: 1 or 2 drops of a 2% solution in each eye twice daily.

Adults

Allergic Conjunctivitis

Ophthalmic

1 or 2 drops of a 2% solution in each eye twice daily.

Cautions for Nedocromil (EENT)

Contraindications

Known hypersensitivity to nedocromil or any ingredient in the formulation.

Warnings/Precautions

General Precautions

Administration

For topical ophthalmic use only.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk in rats following IV administration; not known whether distributed into human milk. Use with caution.

Pediatric Use

Safety and efficacy not established in children <3 years of age.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Headache, ocular discomfort (i.e., burning, irritation, stinging ), unpleasant taste, nasal congestion.

Interactions for Nedocromil (EENT)

No formal drug interaction studies to date.

Nedocromil (EENT) Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed (<4%) following topical application to the eye.

Onset

Rapid onset (within minutes).

Elimination

Metabolism

Not metabolized.

Elimination Route

Excreted principally unchanged in urine (70%) and feces (30%).

Stability

Storage

Ophthalmic

Solution

Tightly closed bottle at 2–25°C.

Actions

Suppresses release of mediators (e.g., histamine) from cells involved in hypersensitivity reactions (including mast cells).
Decreases chemotaxis and activation of eosinophils.
Inhibits release of secondary inflammatory mediators from activated inflammatory cells (e.g., eosinophils, macrophages, neutrophils, monocytes).

Advice to Patients

Importance of learning and adhering to proper administration techniques to avoid contamination of the solution container.
Importance of not wearing contact lenses in the presence of signs and symptoms of allergic conjunctivitis. If contact lenses must be worn, delay insertion of soft contact lenses after instillation, since benzalkonium chloride preservative may be absorbed by some soft contact lenses.
Importance of administering different topical ophthalmic preparations at least 10–15 minutes apart.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.
Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.