Nedocromil Sodium

Generic Name: nedocromil sodium

Over-the-Counter (OTC)

Brand Names:

Alocril

DESCRIPTION ALOCRIL ® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use. Nedocromil sodium is represented by the following structural formula: Chemical N ame: 4 H -Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt.

Overview

DESCRIPTION ALOCRIL ® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use. Nedocromil sodium is represented by the following structural formula: Chemical N ame: 4 H -Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt.

Uses

INDICATIONS AND USAGE ALOCRIL ® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

Dosage

DOSAGE AND ADMINISTRATION The recommended dosage is one or two drops in each eye twice a day. ALOCRIL ® ophthalmic solution should be used at regular intervals. Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

Side Effects

ADVERSE REACTIONS The most frequently reported adverse experience was headache (~40%). Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis. Some of these events were similar to the underlying ocular disease being studied.

Warnings

CONTRAINDICATIONS ALOCRIL ® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

Pregnancy

Pregnancy Teratogenic Effects Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOCRIL ® ophthalmic solution should be used during pregnancy only if clearly needed.

Storage

Storage: Store at 2º–25º C (36º–77º F). Rx only Revised: 0 6 /2018 Distributed by: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners.

Frequently Asked Questions

What is Nedocromil Sodium used for?

INDICATIONS AND USAGE ALOCRIL ® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

What are the side effects of Nedocromil Sodium?

ADVERSE REACTIONS The most frequently reported adverse experience was headache (~40%). Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis. Some of these events were similar to the underlying ocular disease being studied.

Can I take Nedocromil Sodium during pregnancy?

Pregnancy Teratogenic Effects Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOCRIL ® ophthalmic solution should be used during pregnancy only if clearly needed.

What are the important warnings for Nedocromil Sodium?

CONTRAINDICATIONS ALOCRIL ® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.