Nasonex Description

Mometasone Furoate (NASONEX) Aqueous Nasal Spray is an aqueous suspension containing mometasone furoate monohydrate as the active ingredient equivalent to 0.5 mg/g mometasone furoate.
Each metered-dose pump actuation of Mometasone furoate (NASONEX) Aqueous Nasal Spray delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
Each gram contains 500 mcg of Mometasone Furoate.
Mometasone furoate (NASONEX) Aqueous Nasal Spray contains mometasone furoate monohydrate (SCH 32088), a synthetic 17-heterocyclic corticosteroid with anti-inflammatory activity, which is presently being therapeutically used for the treatment of asthma, nasal polyps, rhinitis and sinusitis.
The original formulation of Mometasone furoate (NASONEX) Aqueous Nasal Spray is currently being revised to remove Phenylethyl alcohol (PEA). It was shown that deletion of PEA from Mometasone furoate (NASONEX) Aqueous Nasal Spray does not affect the Antimicrobial Preservative Effectiveness (APE), particle size, droplet size or spray pattern of Mometasone furoate (NASONEX) Aqueous Nasal Spray. Since the two formulations are comparable in the amount of the active substance, mometasone furoate 0.5 mg/g, and in their physical characteristics as mentioned previously, no preclinical or clinical program was conducted with the revised formulation. The formulations are considered pharmaco-toxicologically and clinically equivalent. Unless otherwise specified, Mometasone furoate (NASONEX) Aqueous Nasal Spray collectively refers to the original and revised (PEA free) formulations. Adverse Events, as reported in Adverse Reactions, are those seen in the adult allergic rhinitis clinical program of the Mometasone furoate (NASONEX) Aqueous Nasal Spray original formulation. Similar findings were observed for the nasal polyps, acute rhinosinusitis, adjunctive treatment for sinusitis, and pediatric programs.
Drug Substance: Mometasone furoate monohydrate, 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2)-furoate, is a synthetic, anti-inflammatory corticosteroid whose steroid nucleus is the 16α-methyl analog of beclomethasone, but with a 21-chloro group and a novel (2)-furoate 17-ester function. The empirical formula is C₂₇H₃₀Cl₂O₆·H₂O and Molecular Weight (MW) is 539.45.
Drug Product: Mometasone furoate (NASONEX) Aqueous Nasal Spray is a non-pressurized metered dose nasal sprays designed for local nasal administration. The products consist of a white, high-density polyethylene bottles, supplied with metered-dose, manual, polypropylene spray pump actuators and plastic caps. Each actuation of the metered dose, manual spray pump for intranasal administration delivers an amount of mometasone furoate monohydrate equivalent to 50 μg mometasone furoate.
Excipients/Inactive Ingredients: Dispersible Cellulose BP 65 cps (microcrystalline cellulose and carmellose sodium), Glycerol, Citric Acid Monohydrate, Sodium Citrate Dihydrate, Polysorbate 80, Benzalkonium Chloride, Purified Water.