FLUNISOLIDE spray, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rising Pharmaceuticals, Inc

INN (International Name):

FLUNISOLIDE

Sammensetning:

FLUNISOLIDE 0.25 mg in 1 mL

Administreringsrute:

NASAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 the nasal mucosa. Hypersensitivity to any of the ingredients.

Produkt oppsummering:

Flunisolide Nasal Solution USP 0.025% (Nasal Spray) is supplied in a nasal pump dispenser with dust cover and with patient instructions in the following size: 25 mL bottles NDC 64980-510-25. Each 25 mL flunisolide nasal solution spray bottle contains 6.25 mg (0.25 mg/mL), 200 sprays of flunisolide. Storage: Store between 20° to 25°C (68° to 77°F). KEEP OUT OF REACH OF CHILDREN. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Rev. 931:00 1/12

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FLUNISOLIDE - FLUNISOLIDE SPRAY, METERED
RISING PHARMACEUTICALS, INC
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FLUNISOLIDE NASAL SOLUTION USP, 0.025% (NASAL SPRAY)
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:
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 0.25mg (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 mineral
corticoid 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 effec