DESCRIPTION
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-16 -methylpregna-1,4-diene-3,20-dione 17-( 2 furoate) monohydrate.
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 Nasal Spray, 50 mcg is a metered-dose, manual pump spray unit con-taining an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/ w mometasone furoate calculated on the anhydrous basis; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, 0.25% w/ w phenylethyl alcohol, citric acid, benzalkonium chloride, and polysorbate 80.
The pH is between 4.3 and 4.9. After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100 mg of suspension containing mometasone furoate monohydrate equivalent to 50 mcg of mometasone furoate calculated on the anhydrous basis. Each bottle of NASONEX Nasal Spray, 50 mcg provides 120 sprays.
