BECONASE- beclomethasone dipropionate monohydrate spray, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BECLOMETHASONE DIPROPIONATE MONOHYDRATE (UNII: 4H7L9AI22I) (BECLOMETHASONE - UNII:KGZ1SLC28Z)

Available from:

Stat Rx USA LLC

INN (International Name):

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

Composition:

BECLOMETHASONE DIPROPIONATE MONOHYDRATE 42 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa. BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease. Hypersensitivity to an

Product summary:

BECONASE AQ Nasal Spray, 42 mcg is supplied in an amber glass bottle fitted with a metering atomizing pump and nasal adapter in a box of 1 (NDC 0173-0388-79) with patient’s instructions for use. Each bottle contains 25 g of suspension and will provide 180 metered sprays. The correct amount of medication in each spray cannot be assured after 180 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used. Store between 15° and 30°C (59° and 86°F). GlaxoSmithKline Research Triangle Park, NC 27709 April 2005 RL-2182

Authorization status:

New Drug Application

Summary of Product characteristics

BECONASE AQ- BECLOMETHASONE DIPROPIONATE MONOHYDRATE SPRAY, SUSPENSION
STAT RX USA LLC
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BECONASE (BECLOMETHASONE DIPROPIONATE MONOHYDRATE) SPRAY, SUSPENSION
DESCRIPTION
Beclomethasone dipropionate, monohydrate, the active component of
BECONASE AQ Nasal Spray, is
an anti-inflammatory steroid having the chemical name
9-chloro-11β,17,21-trihydroxy-16β-
methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, monohydrate and
the following chemical
structure:
Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a
synthetic halogenated
corticosteroid. Beclomethasone dipropionate, monohydrate is a white to
creamy-white, odorless
powder with a molecular weight of 539.06. It is very slightly soluble
in water, very soluble in
chloroform, and freely soluble in acetone and in ethanol.
BECONASE AQ Nasal Spray is a metered-dose, manual pump spray unit
containing a microcrystalline
suspension of beclomethasone dipropionate, monohydrate equivalent to
42 mcg of beclomethasone
dipropionate, calculated on the dried basis, in an aqueous medium
containing microcrystalline cellulose,
carboxymethylcellulose sodium, dextrose, benzalkonium chloride,
polysorbate 80, and 0.25% v/w
phenylethyl alcohol. The pH through expiry is 5.0 to 6.8.
After initial priming (6 actuations), each actuation of the pump
delivers from the nasal adapter 100 mg of
suspension containing beclomethasone dipropionate, monohydrate
equivalent to 42 mcg of
beclomethasone dipropionate. If the pump is not used for 7 days, it
should be primed until a fine spray
appears. Each 25-g bottle of BECONASE AQ Nasal Spray provides 180
metered sprays.
CLINICAL PHARMACOLOGYMechanism of Action
Following topical administration, beclomethasone dipropionate produces
anti-inflammatory and
vasoconstrictor effects. The mechanisms responsible for the
anti-inflammatory action of
beclomethasone dipropionate are unknown. Corticosteroids have been
shown to have a wide range of
effects on multiple cell types (e.g., mast cells, eosinophils,
neutrophils, macrophages, and lym