Drug Information for FlunisolideNasal Solution USP, 0.025% (Bausch & Lomb Incorporated): Description

  • 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).