国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Nedocromil Sodium (UNII: ET8IF4KS1T) (Nedocromil - UNII:0B535E0BN0)
Akorn
Nedocromil Sodium
Nedocromil Sodium 20 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Nedocromil Sodium Ophthalmic Solution is indicated for the treatment of itching associated with allergic conjunctivitis. Nedocromil Sodium Ophthalmic Solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
Nedocromil Sodium Ophthalmic Solution, 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white polypropylene caps as follows: 5 mL in a 10 cc bottle - NDC 17478-066-10 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Akorn Lake Forest, IL 60045 NS00N Revision: April 2009
Abbreviated New Drug Application
NEDOCROMIL SODIUM- NEDOCROMIL SODIUM SOLUTION/ DROPS AKORN ---------- NEDOCROMIL SODIUM OPHTHALMIC SOLUTION, 2% STERILE Rx only 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. PRECAUTIONS INFORMATION FOR PATIENTS Patients should be advised to follow the patient 完全なドキュメントを読む