FLUNISOLIDE solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

FLUNISOLIDE

Composición:

FLUNISOLIDE 0.25 mg in 1 mL

Vía de administración:

NASAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

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 - Prod. No. 34454             NDC 54868-4799-0 Each 25 mL flunisolide nasal solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 sprays of flunisolide.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

FLUNISOLIDE - FLUNISOLIDE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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FLUNIS OLIDE
NASAL SOLUTION USP, 0.025%
DES CRIPTION
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
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 ADDED: 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 that the
clinical effectiveness of flunisolide nasal