FDA records indicate that there are no current recalls for this drug.
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Nedocromil Sodium Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Nedocromil Sodium Ophthalmic Solution is indicated for the treatment of itching associated with allergic conjunctivitis.
History
There is currently no drug history available for this drug.
Other Information
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 name: 4H-Pyrano[3,2-g] quinoline-2, 8-dicarboxylic acid, 9-ethyl-6,9-dihydro- 4,6-dioxo-10-propyl-, disodium salt.
Each mL contains: Active: Nedocromil Sodium 20 mg/mL (2%); Preservative: Benzalkonium Chloride 0.01%; Inactives: Edetate Disodium 0.05%, Purified Water, and Sodium Chloride 0.5%. It has a pH of 4.0 to 5.5 and osmolality range of 270 to 330 mOsm/kg.
Sources
Nedocromil Sodium Solution/ Drops Manufacturers
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Akorn, Inc.
Nedocromil Sodium Solution/ Drops | Akorn, Inc.
The recommended dosage is one or two drops in each eye twice a day. Nedocromil Ophthalmic Solution 2% 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.
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