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BECONASE
Overview
What is BECONASE?
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.
What does BECONASE look like?
What are the available doses of BECONASE?
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What should I talk to my health care provider before I take BECONASE?
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How should I use BECONASE?
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.
The usual dosage is 1 or 2 nasal inhalations (42 to 84 mcg) in
each nostril twice a day (total dose, 168 to 336 mcg/day).
Patients should be started with 1 nasal inhalation in each
nostril twice daily; patients not adequately responding to 168 mcg or those with
more severe symptoms may use 336 mcg (2 inhalations in each nostril). Once
adequate control is achieved, the dosage should be decreased to 84 mcg (1 spray
in each nostril) twice daily. BECONASE AQ Nasal Spray is recommended for children below 6 years of age.
The maximum total daily dosage should not exceed 2 sprays in each nostril
twice daily (336 mcg/day).
In patients who respond to BECONASE AQ Nasal Spray, an improvement of the
symptoms of seasonal or perennial rhinitis usually becomes apparent within a few
days after the start of therapy with BECONASE AQ Nasal Spray. 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.
The therapeutic effects of corticosteroids, unlike those of decongestants,
are not immediate. This should be explained to the patient in advance in order
to ensure cooperation and continuation of treatment with the prescribed dosage
regimen.
In the presence of excessive nasal mucous secretion or edema of the nasal
mucosa, the drug may fail to reach the site of intended action. In such cases it
is advisable to use a nasal vasoconstrictor during the first 2 to 3 days of
therapy with BECONASE AQ Nasal Spray.
Illustrated Patient's Instructions for Use accompany each package
of BECONASE AQ Nasal Spray.
What interacts with BECONASE?
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What are the warnings of BECONASE?
Sorry No Records found
What are the precautions of BECONASE?
Sorry No Records found
What are the side effects of BECONASE?
Sorry No records found
What should I look out for while using BECONASE?
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.
What might happen if I take too much BECONASE?
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 3,000 mg/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 2,000 mg/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 10.5 mg of beclomethasone
dipropionate; therefore, acute overdosage is unlikely.
How should I store and handle BECONASE?
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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182BECONASE 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).GlaxoSmithKlineResearch Triangle Park, NC 27709April 2005 RL-2182
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and
cytokines) involved in inflammation. The direct relationship of these findings
to the effects of beclomethasone dipropionate on allergic rhinitis symptoms is
not known.
Biopsies of nasal mucosa obtained during clinical studies showed no
histopathologic changes when beclomethasone dipropionate was administered
intranasally.
Beclomethasone dipropionate is a pro-drug with weak glucocorticoid receptor
binding affinity. It is hydrolyzed via esterase enzymes to its active metabolite
beclomethasone-17-monopropionate (B-17-MP), which has high topical
anti-inflammatory activity.
Beclomethasone dipropionate is sparingly soluble in water. When
given by nasal inhalation in the form of an aqueous or aerosolized suspension,
the drug is deposited primarily in the nasal passages. The majority of the drug
is eventually swallowed. Following intranasal administration of aqueous
beclomethasone dipropionate, the systemic absorption was assessed by measuring
the plasma concentrations of its active metabolite B-17-MP, for which the
absolute bioavailability following intranasal administration is 44% (43% of the
administered dose came from the swallowed portion and only 1% of the total dose
was bioavailable from the nose). The absorption of unchanged beclomethasone
dipropionate following oral and intranasal dosing was undetectable (plasma
concentrations less than 50 pg/mL).
The tissue distribution at steady state for beclomethasone
dipropionate is moderate (20 L) but more extensive for B-17-MP (424 L). There is
no evidence of tissue storage of beclomethasone dipropionate or its metabolites.
Plasma protein binding is moderately high (87%).
Beclomethasone dipropionate is cleared very rapidly from the
systemic circulation by metabolism mediated via esterase enzymes that are found
in most tissues. The main product of metabolism is the active metabolite
(B-17-MP). Minor inactive metabolites, beclomethasone-21-monopropionate
(B-21-MP) and beclomethasone (BOH), are also formed, but these contribute little
to systemic exposure.
The elimination of beclomethasone dipropionate and B-17-MP after
intravenous administration are characterized by high plasma clearance (150 and
120 L/hour) with corresponding terminal elimination half-lives of 0.5 and
2.7 hours. Following oral administration of tritiated beclomethasone
dipropionate, approximately 60% of the dose was excreted in the feces within
96 hours, mainly as free and conjugated polar metabolites. Approximately 12% of
the dose was excreted as free and conjugated polar metabolites in the urine. The
renal clearance of beclomethasone dipropionate and its metabolites is
negligible.
The effects of beclomethasone dipropionate on
hypothalamic-pituitary-adrenal (HPA) function have been evaluated in adult
volunteers by other routes of administration. Studies with beclomethasone
dipropionate by the intranasal route may demonstrate that there is more or that
there is less absorption by this route of administration. There was no
suppression of early morning plasma cortisol concentrations when beclomethasone
dipropionate was administered in a dose of 1,000 mcg/day for 1 month as an oral
aerosol or for 3 days by intramuscular injection. However, partial suppression
of plasma cortisol concentrations was observed when beclomethasone dipropionate
was administered in doses of 2,000 mcg/day either by oral aerosol or
intramuscular injection. Immediate suppression of plasma cortisol concentrations
was observed after single doses of 4,000 mcg of beclomethasone dipropionate.
Suppression of HPA function (reduction of early morning plasma cortisol levels)
has been reported in adult patients who received 1,600-mcg daily doses of oral
beclomethasone dipropionate for 1 month. In clinical studies using
beclomethasone dipropionate aerosol intranasally, there was no evidence of
adrenal insufficiency. The effect of BECONASE AQ Nasal Spray on HPA function was
not evaluated but would not be expected to differ from intranasal beclomethasone
dipropionate aerosol.
In 1 study in children with asthma, the administration of inhaled
beclomethasone at recommended daily doses for at least 1 year was associated
with a reduction in nocturnal cortisol secretion. The clinical significance of
this finding is not clear. It reinforces other evidence, however, that topical
beclomethasone may be absorbed in amounts that can have systemic effects and
that physicians should be alert for evidence of systemic effects, especially in
chronically treated patients (see PRECAUTIONS).
Non-Clinical Toxicology
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.
Drug interaction studies with mycophenolate mofetil have been conducted with acyclovir, antacids, cholestyramine, cyclosporine, ganciclovir, oral contraceptives, sevelamer, trimethoprim/sulfamethoxazole, norfloxacin, and metronidazole. Drug interaction studies have not been conducted with other drugs that may be commonly administered to renal, cardiac or hepatic transplant patients. Mycophenolate mofetil has not been administered concomitantly with azathioprine.
Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS: Pediatric Use).
During withdrawal from oral corticosteroids, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression.
Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of beclomethasone (see ADVERSE REACTIONS).
Rare instances of nasal septum perforation have been spontaneously reported.
Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal use of beclomethasone dipropionate.
In clinical studies with beclomethasone dipropionate administered intranasally, the development of localized infections of the nose and pharynx with has occurred only rarely. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of treatment with BECONASE AQ Nasal Spray.
If persistent nasopharyngeal irritation occurs, it may be an indication for stopping BECONASE AQ Nasal Spray.
Beclomethasone dipropionate is absorbed into the circulation. Use of excessive doses of BECONASE AQ Nasal Spray may suppress HPA function.
Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.
For BECONASE AQ Nasal Spray to be effective in the treatment of nasal polyps, the spray must be able to enter the nose. Therefore, treatment of nasal polyps with BECONASE AQ Nasal Spray should be considered adjunctive therapy to surgical removal and/or the use of other medications that will permit effective penetration of BECONASE AQ Nasal Spray into the nose. Nasal polyps may recur after any form of treatment.
As with any long-term treatment, patients using BECONASE AQ Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
Although systemic effects have been minimal with recommended doses, this potential increases with excessive doses. Therefore, larger than recommended doses should be avoided.
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 PRECAUTIONS).
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 PRECAUTIONS).
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 PRECAUTIONS: Pediatric Use).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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