FLUNISOLIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUNISOLIDE (UNII: QK4DYS664X) (FLUNISOLIDE ANHYDROUS - UNII:78M02AA8KF)

Available from:

Ingenus Pharmaceuticals, LLC

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity to any of the ingredients.

Product summary:

Flunisolide Nasal Solution USP, 0.025% is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size: 25 mL bottles – NDC 50742-317-25 Each 25 mL flunisolide nasal solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 metered sprays of flunisolide.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUNISOLIDE- FLUNISOLIDE SOLUTION
INGENUS PHARMACEUTICALS, LLC
----------
FLUNISOLIDE
NASAL SOLUTION USP, 0.025%
RX ONLY
FOR INTRANASAL USE ONLY
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
H
FO
Mol. Wt. 434.51
Chemical Name: 6α-fluoro-11β, 16α,17
,21-tetrahydroxypregna-1,4-di-ene-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 25 mL flunisolide nasal solution spray bottle contains 6.25 mg
(0.25 mg/mL).
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%.
24
31
6
CLINICAL PHARMACOLOGY
Flunisolide has demonstrated potent glucocorticoid and weak
mineralocorticoid activity in
classical animal test systems. As a glucocorticoid, it is several
hundred times more
potent than the cortisol standard. Clinical studies with flunisolide
have shown therapeutic
activity on nasal mucous membranes with minimal evidence of systemic
activity at the
recommended doses.
A study in approximately 100 patients that compared the recommended
dose of
flunisolide nasal solution wi