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Beclomethasone Dipropionate Monohydrate - Aq (Beconase)

Trade Name : BECONASE

GlaxoSmithKline LLC

SPRAY, SUSPENSION

Strength 42 ug/1

BECLOMETHASONE DIPROPIONATE MONOHYDRATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Beclomethasone Dipropionate Monohydrate - Aq (Beconase) which is also known as BECONASE and Manufactured by GlaxoSmithKline LLC. It is available in strength of 42 ug/1 per ml. Read more

Beclomethasone Dipropionate Monohydrate - Aq (Beconase) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Beclomethasone dipropionate, monohydrate, the active component of BECONASE AQ Nasal Spray, is an anti-inflammatory steroid having the chemical name 9-chloro-11u03b2,17,21-trihydroxy-16u03b2-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 42u00a0mcg 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%u00a0v/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 100u00a0mg of suspension containing beclomethasone dipropionate, monohydrate equivalent to 42u00a0mcg of beclomethasone dipropionate. If the pump is not used for 7u00a0days, it should be primed until a fine spray appears. Each 25-g bottle of BECONASE AQ Nasal Spray provides 180 metered sprays.
  • No data
  • 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 3u00a0days. However, symptomatic relief may not occur in some patients for as long as 2u00a0weeks. BECONASE AQ Nasal Spray should not be continued beyond 3u00a0weeks 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 any of the ingredients of this preparation contraindicates its use.
  • The replacement of a systemic corticosteroid with BECONASE AQ Nasal Spray can be accompanied by signs of adrenal insufficiency.
  • Careful attention must be given when patients previously treated for prolonged periods with systemic corticosteroids are transferred to BECONASE AQ Nasal Spray. This is particularly important in those patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
  • If recommended doses of intranasal beclomethasone are exceeded or if individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapy, symptoms of hypercorticism may occur, including very rare cases of menstrual irregularities, acneiform lesions, cataracts, and cushingoid features. If such changes occur, BECONASE AQ Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy.
  • Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.
  • Avoid spraying in eyes.
  • No data
  • In general, side effects in clinical studies have been primarily associated with irritation of the nasal mucous membranes.
  • Adverse reactions reported in controlled clinical trials and open studies in patients treated with BECONASE AQ Nasal Spray are described below.
  • Mild nasopharyngeal irritation following the use of beclomethasone aqueous nasal spray has been reported in up to 24% of patients treated, including occasional sneezing attacks (about 4%) occurring immediately following use of the spray. In patients experiencing these symptoms, none had to discontinue treatment. The incidence of transient irritation and sneezing was approximately the same in the group of patients who received placebo in these studies, implying that these complaints may be related to vehicle components of the formulation.
  • Fewer than 5 per 100 patients reported headache, nausea, or lightheadedness following the use of BECONASE AQ Nasal Spray. Fewer than 3 per 100 patients reported nasal stuffiness, nosebleeds, rhinorrhea, or tearing eyes.
  • Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported (see ).
  • Reports of dryness and irritation of the nose and throat and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell.
  • Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone dipropionate (see ).
  • Rare cases of immediate and delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.
  • Cases of growth suppression have been reported for intranasal corticosteroids, including BECONASE AQ (see ).
  • When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, BECONASE AQ Nasal Spray should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy. No deaths occurred when beclomethasone dipropionate was given as single oral doses of 3,000u00a0mg/kg to mice (approximately 36,000 times the maximum recommended daily intranasal dose in adults on a mg/m basis, or approximately 21,000 times the maximum recommended daily intranasal dose in children on a mg/m basis) and 2,000u00a0mg/kg to rats (approximately 48,000 times the maximum recommended daily intranasal dose in adults or approximately 29,000 times the maximum recommended daily intranasal dose in children on a mg/m basis). One bottle of BECONASE AQ Nasal Spray contains beclomethasone dipropionate, monohydrate equivalent to 10.5u00a0mg of beclomethasone dipropionate; therefore, acute overdosage is unlikely.
  • No data
  • BECONASE AQ Nasal Spray, 42u00a0mcg 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 patientu2019s instructions for use. Each bottle contains 25u00a0g 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 15u00b0 and 30u00b0C (59u00b0 and 86u00b0F).
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Trademarks are owned by or licensed to the GSK group of companies.
  • u00a92019 GSK group of companies or its licensor.
  • April 2019
  • BCN:2PI
  • BECONASE AQ
  • (beclomethasone dipropionate,
  • monohydrate)
  • Nasal Spray, 42 mcg
  • For Intranasal Use Only. SHAKE WELL BEFORE USE.
  • Patientu2019s Instructions for Use
  • Shake the suspension spray bottle well before using it. Read complete instructions carefully and use only as directed.
  • To Use:
  • 1.
  • 2.
  • The pump is now ready for use. If the pump is not used for 7 days, prime until a fine spray appears.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8. DISCARD THE BOTTLE AFTER
  • Cleansing:
  • If the nasal applicator becomes blocked, remove the dust cap, unscrew the complete pump mechanism, and soak the pump in warm water for a few minutes. Rinse with cold water, dry, refit to bottle, and reprime the pump.
  • Caution:
  • Storage:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Trademarks are owned by or licensed to the GSK group of companies.
  • u00a92019 GSK group of companies or its licensor.
  • April 2019
  • BCN:2PIL
  • NDC 0173-0388-79
  • Arrayn- Beconase AQ
  • Arrayn- (beclomethasone dipropionate, monohydrate)
  • Arrayn- Nasal Spray, 42 mcg
  • Arrayn- 25 g
  • Arrayn- 180 Metered Sprays
  • Spray-For Intranasal Use Only
  • R only
  • Important:
  • Made in Canada
  • u00a92017 GSK group of companies or its licensor.

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