Nedocromil Ophthalmic Solution
Generic name: nedocromil sodium
Dosage form: ophthalmic solution
Drug class:Ophthalmic antihistamines and decongestants
Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.
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DESCRIPTION
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.
CLINICAL PHARMACOLOGY
Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.
In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.
Pharmacokinetics and Bioavailability
Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).
INDICATIONS AND USAGE
Nedocromil Sodium Ophthalmic Solution is indicated for the treatment of itching associated with allergic conjunctivitis.
CONTRAINDICATIONS
Nedocromil Sodium Ophthalmic Solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
