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Drug Information for FlunisolideNasal Solution USP, 0.025% (Bausch & Lomb Incorporated): Description
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Flunisolide Nasal Solution USP, 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of flunisolide nasal solution, is an anti-inflammatory steroid.
Flunisolide is represented by the following structural formula:
C24H31FO6 • 1/2H2O Mol. Wt. 443.52
6a-fluoro-11ß 16a,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (USAN).
Flunisolide is a white to creamy white crystalline powder. It is soluble in acetone, sparingly soluble in chloroform, slightly soluble in methanol, and practically insoluble in water. It has a melting point of about 245°C.
After initial priming (5 to 6 sprays) each spray of the unit delivers a metered droplet spray of 100 mg formulation containing 25 mcg of flunisolide.
The size of the droplets produced by the unit is in excess of 8 microns to facilitate deposition on the nasal mucosa. The contents of one nasal spray bottle delivers 200 sprays.
Each mL Contains: ACTIVE: Flunisolide 0.25 mg (0.025%); INACTIVES: Propylene Glycol, Polyethylene Glycol 3350, Butylated Hydroxyanisole, Edetate Disodium, Sodium Citrate, Citric Acid and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1 – 5.4). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
- Drug Information Provided by National Library of Medicine (NLM).