Nedocromil eent

Class: Antiallergic Agents
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

Introduction

Mast-cell stabilizer.^{1 3 5}

Uses for Nedocromil

Allergic Conjunctivitis

Symptomatic treatment of ocular itching associated with allergic conjunctivitis.^{1 3}

Nedocromil Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.^{1 3} Administer at regular intervals.¹

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

Avoid contamination of the solution container.²

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.^{1 2 3}

Dosage

Available as nedocromil sodium; dosage expressed in terms of the salt.¹

Pediatric Patients

Allergic Conjunctivitis

Ophthalmic

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

Adults

Allergic Conjunctivitis

Ophthalmic

1 or 2 drops of a 2% solution in each eye twice daily.^{1 3}

Cautions for Nedocromil

Contraindications

• Known hypersensitivity to nedocromil or any ingredient in the formulation.^{1 3}

Warnings/Precautions

General Precautions

Administration

For topical ophthalmic use only.^{1 3}

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk in rats following IV administration; not known whether distributed into human milk.^{1 3} Use with caution.^{1 3}

Pediatric Use

Safety and efficacy not established in children <3 years of age.^{1 3}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^{1 3}

Common Adverse Effects

Headache,^{1 8} ocular discomfort (i.e., burning,^{1 3 4 6 8} irritation,^{1 3 6} stinging^{1 3 4 6 8} ), unpleasant taste,^{1 3 4 6} nasal congestion.^{1 3}

Interactions for Nedocromil

No formal drug interaction studies to date.³

Nedocromil Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed (<4%) following topical application to the eye.¹

Onset

Rapid onset (within minutes).^{3 8}

Elimination

Metabolism

Not metabolized.¹

Elimination Route

Excreted principally unchanged in urine (70%) and feces (30%).¹

Stability

Storage

Ophthalmic

Solution

Tightly closed bottle at 2–25°C.¹

Actions

• Suppresses release of mediators (e.g., histamine) from cells involved in hypersensitivity reactions (including mast cells).^{1 3 4}

• Decreases chemotaxis and activation of eosinophils.^{1 3 4}

• Inhibits release of secondary inflammatory mediators from activated inflammatory cells (e.g., eosinophils, macrophages, neutrophils, monocytes).^{1 3 4}

Advice to Patients

• Importance of learning and adhering to proper administration techniques to avoid contamination of the solution container.¹

• Importance of not wearing contact lenses in the presence of signs and symptoms of allergic conjunctivitis.¹ 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.³

• Importance of administering different topical ophthalmic preparations at least 10–15 minutes apart.^a

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

• 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.