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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

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

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 stinging1 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.

Nedocromil

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

2%

Alocril (with benzalkonium chloride)

Allergan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Alocril 2% Solution (ALLERGAN): 5/$104.99 or 15/$304.48

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Allergan, Inc. Alocril (nedocromil sodium) ophthalmic solution 2% prescribing information. Irvine, CA; 2000.

2. Allergan. A patient’s guide to the treatment of itchy allergy eyes. From Allergan website ().

3. Allergan, Inc. Alocril (nedocromil sodium) formulary information. Irvine, CA; 2000.

4. Blumenthal M, Casale T, Dockhorn R et al. Efficacy and safety of nedocromil sodium ophthalmic solution in the treatment of seasonal allergic conjunctivitis. Am J Ophthalmol. 1992; 113:56-63. [IDIS 289823] [PubMed 1309410]

5. Blumenthal MN, Schwartz RH, Kaiser H. Nedocromil sodium 2% ophthalmic solution for the treatment of ragweed pollen seasonal allergic conjunctivitis. Ocul Immunol Inflamm. 2000; 8:159-67. [PubMed 11120577]

6. Melamed J, Schwartz RH, Hirsch SR et al. Evaluation of nedocromil sodium 2% ophthalmic solution for the treatment of seasonal allergic conjunctivitis. Ann Allergy. 1994; 73:57-66. [IDIS 333818] [PubMed 8030804]

7. Moller C, Berg IM, Berg T et al. Nedocromil sodium 2% eye drops for twice-daily treatment of seasonal allergic conjunctivitis: a Swedish multicentre placebo-controlled study in children allergic to birch pollen. Clin Exp Allergy. 1994; 24:884-7. [PubMed 7812890]

8. Alexander M, Rosen LJ, Yang WH. Comparison of topical nedocromil sodium and oral terfenadine for the treatment of seasonal allergic conjunctivitis. Clin Ther. 1999; 21:1900-7. [IDIS 440862] [PubMed 10890262]

9. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. [IDIS 360840] [PubMed 1372215]

10. Morrow GL, Abbott RL. Conjunctivitis. Am Fam Physician. 1998; 57:735-46. [IDIS 418448] [PubMed 9490996]

11. Titi MJ. A critical look at ocular allergy drugs. Am Fam Physician. 1996; 53:2637-42. [IDIS 367250] [PubMed 8644576]

12. Galindez OA, Kaufman HE. Coping with the itchy-burnies: the management of allergic conjunctivitis. Ophthalmology. 1996; 103:1335-6. [IDIS 373485] [PubMed 8841290]

a. Allergan Inc; Irvine, CA: Personal communication.

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