FLUNISOLIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bausch & Lomb Incorporated

INN (International Name):

FLUNISOLIDE

Composition:

FLUNISOLIDE 0.25 mg in 1 mL

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: Each 25 mL Flunisolide Nasal Solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 metered sprays of flunisolide. Storage: Store between 15° to 25°C (59° to 77°F). Keep out of reach of children. 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 © 2019 Bausch & Lomb Incorporated or its affiliates Revised: May 2019 9681901

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUNISOLIDE- FLUNISOLIDE SOLUTION
BAUSCH & LOMB INCORPORATED
----------
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
• 1/2H
O
Mol. Wt. 443.52
Chemical Name:
24
31
6
2
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%.
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 with an oral dose providing equivalent
systemic amounts of
flunisolide has shown