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. Last updated on Aug 24, 2020.
Introduction
Uses for Nedocromil (EENT)
Allergic Conjunctivitis
Symptomatic treatment of ocular itching associated with allergic conjunctivitis.1 3
Nedocromil (EENT) 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 (EENT)
Contraindications
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 (EENT)
No formal drug interaction studies to date.3
Nedocromil (EENT) 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
-
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.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Ophthalmic |
Solution |
2% |
Alocril (with benzalkonium chloride) |
Allergan |
AHFS DI Essentials™. © Copyright 2021, Selected Revisions September 1, 2005. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, 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 (http://www.alocril.com/2_PATIENTS/index_04.html).
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. http://www.ncbi.nlm.nih.gov/pubmed/1309410?dopt=AbstractPlus
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. http://www.ncbi.nlm.nih.gov/pubmed/11120577?dopt=AbstractPlus
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. http://www.ncbi.nlm.nih.gov/pubmed/8030804?dopt=AbstractPlus
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. http://www.ncbi.nlm.nih.gov/pubmed/7812890?dopt=AbstractPlus
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. http://www.ncbi.nlm.nih.gov/pubmed/10890262?dopt=AbstractPlus
9. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. http://www.ncbi.nlm.nih.gov/pubmed/1372215?dopt=AbstractPlus
10. Morrow GL, Abbott RL. Conjunctivitis. Am Fam Physician. 1998; 57:735-46. http://www.ncbi.nlm.nih.gov/pubmed/9490996?dopt=AbstractPlus
11. Titi MJ. A critical look at ocular allergy drugs. Am Fam Physician. 1996; 53:2637-42. http://www.ncbi.nlm.nih.gov/pubmed/8644576?dopt=AbstractPlus
12. Galindez OA, Kaufman HE. Coping with the itchy-burnies: the management of allergic conjunctivitis. Ophthalmology. 1996; 103:1335-6. http://www.ncbi.nlm.nih.gov/pubmed/8841290?dopt=AbstractPlus
a. Allergan Inc; Irvine, CA: Personal communication.
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