AEROSPAN- flunisolide aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

flunisolide hemihydrate (UNII: QK4DYS664X) (flunisolide - UNII:QK4DYS664X)

Available from:

Forest Pharmaceuticals, Inc.

INN (International Name):

flunisolide

Pharmaceutical form:

AEROSOL, METERED

Composition:

80 ug

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AEROSPAN Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN Inhalation Aerosol is also indicated for asthma patients requiring oral corticosteroid therapy, where adding AEROSPAN Inhalation Aerosol may reduce or eliminate the need for oral corticosteroids. AEROSPAN Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. AEROSPAN Inhalation Aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to flunisolide or any of the ingredients of this preparation contraindicates the use of AEROSPAN Inhalation Aerosol.

Product summary:

AEROSPAN Inhalation Aerosol is supplied as a pressurized lined aluminum canister in boxes of one. Each canister is supplied with a two-piece plastic purple actuator and gray spacer assembly, and tear-off patient's instructions, including a Patient Information and an illustrated Instructions for Using Your AEROSPAN Inhalation Aerosol. The following canister sizes are available: 8.9 g net weight, providing 120 metered actuations (trade size, NDC 0456-5550-12); 5.1 g net weight providing 60 metered actuations (hospital size, NDC 0456-5550-63); 5.1 g net weight providing 60 metered actuations (professional sample, NDC 0456-5550-06). When not in use, keep AEROSPAN Inhalation Aerosol out of reach of children. Pediatric patients should only administer AEROSPAN Inhalation Aerosol under adult supervision. The plastic purple actuator and gray spacer assembly supplied as part of AEROSPAN Inhalation Aerosol should not be used with any other product canisters; and the actuator from other products should not be used with an AEROSPAN Inhalation Aerosol canister. Do not separate the purple actuator from the gray spacer. Do not use this product with any external spacer devices. The labeled amount of medication in each actuation cannot be assured after 120 metered actuations (or 60 metered actuations in the hospital and sample size canisters), even though the canister is not completely empty and will continue to operate. The inhaler (canister plus actuator) should be discarded when the labeled number of actuations have been used. Never immerse the canister into water to determine the amount of formulation remaining in the canister (“float test”). Store at 25 °C (77 °F); excursions permitted to 15 – 30 °C (59 – 86 °F) [see USP Controlled Room Temperature]. For best results, the canister should be at room temperature before use. WARNING: Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Protect from freezing temperatures and prolonged exposure to sunlight. Exposure to temperatures above 120°F (49°C) may cause bursting. Never throw into fire or incinerator. Use by children should always be supervised. Avoid spraying in eyes. AEROSPAN Inhalation Aerosol does not contain chlorofluorocarbons (CFCs). Manufactured By: 3M Pharmaceuticals, Inc. St. Paul, MN 55133 For: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045 1/06

Summary of Product characteristics

AEROSPAN- FLUNISOLIDE AEROSOL, METERED
FOREST PHARMACEUTICALS, INC.
----------
AEROSPAN™
(FLUNISOLIDE HFA, 80 MCG)
INHALATION AEROSOL
FOR ORAL INHALATION ONLY
RX ONLY
DESCRIPTION
Flunisolide hemihydrate, the active component of AEROSPAN
(flunisolide HFA, 80 mcg) Inhalation
Aerosol, is a corticosteroid having the chemical name 6α-Fluoro-11β,
16α, 17, 21 –
tetrahydroxylpregna-1, 4-diene-3, 20-dione cyclic-16, 17-acetal with
acetone, hemihydrate and the
following chemical structure:
Flunisolide hemihydrate is a white to creamy white crystalline powder
with a molecular weight of
443.51 and an empirical formula of C
H O F •½ H O. It is soluble in acetone, ethyl alcohol and
HFA-134a and practically insoluble in water.
AEROSPAN Inhalation Aerosol is a pressurized, metered-dose inhaler
unit intended for oral inhalation
only. The inhaler unit consists of a metal canister, a purple
actuator, and a gray spacer. Each unit
contains a 0.24 % w/w solution of flunisolide hemihydrate in 10:90 w/w
ethanol:1,1,1,2-
tetrafluoroethane (HFA 134a). After priming, each actuation delivers
139 mcg of flunisolide
hemihydrate in 58 mg of solution from the canister valve and 80 mcg of
flunisolide hemihydrate
(equivalent to 78 mcg flunisolide) from the spacer at a flow rate of
30 L/min for 4 seconds.
Using an _in-vitro_ method at a fixed volume of 2 L, each actuation at
the beginning of canister content
delivers from the spacer 76 mcg (95% of the label claim) at a flow
rate of 30 L/min, 61 mcg (76% of
the label claim) at a flow rate of 20 L/min, 85 mcg (106% of the label
claim) at a flow rate of 40 L/min,
and 96 mcg (120% of the label claim) at a flow rate of 60 L/min. The
actual amount of drug delivered to
the lung may depend upon patient factors, such as timing and
coordination between the actuation and
inspiration and the strength and duration of the inspiration. Data
show that both the one- and two-
actuation doses are depleted by 75% or more after waiting one second
between actuation and inhalation.
The 5.1-g net weight caniste