Source: FDA, National Drug Code (US) Revision Year: 2020
Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, and the following chemical structure:
Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6•H2O, and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5000.
NASONEX is a metered-dose, manual pump spray. After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100 mcg or 100 microliter of aqueous suspension of mometasone furoate monohydrate equivalent to 50 mcg (0.05% w/w) mometasone furoate calculated on the anhydrous basis; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The pH is between 4.3 and 4.9.
| Dosage Forms and Strengths |
|---|
|
Nasal spray: 50 mcg, metered-dose, manual pump spray. After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 50 mcg of mometasone furoate. |
| How Supplied |
|---|
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NASONEX Nasal Spray:
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: MSD International GmbH (Singapore Branch), Singapore 638414, Singapore |
| Drug | Countries | |
|---|---|---|
| NASONEX | Austria, Brazil, Canada, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States, South Africa |
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