Source: FDA, National Drug Code (US) Revision Year: 2019
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
Chemical Name:
6α-fluoro-11β,16α,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: Benzalkonium Chloride 0.01%.
| How Supplied |
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Flunisolide Nasal Solution, USP 0.025% is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size: NDC 24208-344-25 25 mL bottle Each 25 mL Flunisolide Nasal Solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 metered sprays of flunisolide. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, USA Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada |
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