Flunisolidedrug info
flunisolide 0.025 MG/ACTUAT Metered Dose Nasal Spray
What it is used for
Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 2, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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: C 24 H 31 FO 6 Mol. Wt.
434.51 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: Butylated Hydroxyanisole, Citric Acid, Edetate Disodium Dihydrate, Polyethylene Glycol 3350, Propylene Glycol, Purified Water, and Sodium Citrate. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (5.1–5.4).
PRESERVATIVE: Benzalkonium Chloride 0.01%. C24H31FO6 Chemical Name
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 2, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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