Drugs Details

Drugs Info of Beconase AQ, Qnasl
Drugs Details
  • Drugs Type  : FDA
  • Date : 29th Dec 2014 05:28 am
  • Brand Name : Beconase AQ, Qnasl
  • Generic Name : beclomethasone nasal (Pronunciation: BE kloe METH a sone)
Descriptions

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:

 

BECONASE AQ (beclomethasone dipropionate, monohydrate) structural formula illustration

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 are the possible side effects of beclomethasone nasal (Beconase AQ, Qnasl)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • blurred vision, eye pain, or seeing halos around lights; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • sneezing, runny or stuffy...

Read All Potential Side Effects and See Pictures of Beconase-AQ »

What are the precautions when taking beclomethasone dipropionate, monohydrate (Beconase-AQ)?

Before using nasal beclomethasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more...

Read All Potential Precautions of Beconase-AQ »

This monograph has been modified to include the generic and brand name in many instances.

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.

Dosage Administration

Adults and Children 12 Years of Age and Older

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).

Children 6 to 12 Years of Age

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 not 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.

Directions for Use

Illustrated Patient's Instructions for Use accompany each package of BECONASE AQ Nasal Spray.

How Supplied

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. FDA rev date: 10/27/2005

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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).

Read the Beconase-AQ (beclomethasone dipropionate, monohydrate) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

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.

Precautions

General: 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 Candida albicans 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.

Information for Patients

Patients being treated with BECONASE AQ Nasal Spray should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients should use BECONASE AQ Nasal Spray at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective, and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of BECONASE AQ Nasal Spray are fully manifested. One to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, if the condition worsens, or if sneezing or nasal irritation occurs.

For the proper use of BECONASE AQ Nasal Spray and to attain maximum improvement, the patient should read and follow carefully the patient's instructions accompanying the product.

Persons who are using immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenicity of beclomethasone dipropionate was evaluated in rats that were exposed for a total of 95 weeks, 13 weeks at inhalation doses up to 0.4 mg/kg and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg. There was no evidence of carcinogenicity in this study at the highest dose, approximately 60 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis or approximately 35 times the maximum recommended daily intranasal dose in children on a mg/m2 basis.

Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese hamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg (approximately 390 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). There was no significant effect of beclomethasone dipropionate on fertility in rats at oral doses of 1.6 mg/kg (approximately 40 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). Inhibition of the estrous cycle in dogs was observed following oral dosing at 0.5 mg/kg (approximately 40 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). No inhibition of the estrous cycle in dogs was seen following 12 months' exposure at an estimated inhalation dose of 0.33 mg/kg (approximately 25 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

Pregnancy

Teratogenic Effects: Pregnancy Category C. Like other corticosteroids, beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbit at a subcutaneous dose of 0.1 mg/kg in mice or 0.025 mg/kg in rabbits (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m2 basis). No teratogenicity or embryocidal effects were seen in rats when exposed to an inhalation dose of 0.1 mg/kg plus oral doses of up to 10 mg/kg per day for a combined dose of 10.1 mg/kg (approximately 240 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

There are no adequate and well-controlled studies in pregnant women. Beclomethasone dipropionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.

Nursing Mothers

It is not known whether beclomethasone dipropionate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when BECONASE AQ Nasal Spray is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BECONASE AQ Nasal Spray have been established in children aged 6 years and above through evidence from extensive clinical use in adult and pediatric patients. The safety and effectiveness of BECONASE AQ Nasal Spray in children below 6 years of age have not been established.

Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including BECONASE AQ Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including BECONASE AQ Nasal Spray, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

In a double-blind, controlled trial, 100 children between the ages of 6 and 9½ years with allergic rhinitis were randomized to receive aqueous intranasal beclomethasone dipropionate 168 mcg twice daily or placebo for 1 year. As measured by stadiometry, children who received beclomethasone dipropionate grew more slowly than those who received placebo. A difference in mean change in height was observed within 1 month of drug initiation. At the end of 12 months, the beclomethasone dipropionate-treated group had a growth velocity on average of 4.75 cm/year compared to 6.20 cm/year in the placebo group (p < 0.01). While the placebo group had an expected distribution of growth velocity, approximately 50% of the beclomethasone dipropionate-treated children grew below the 10th percentile.

In children 7.3 years of age, the mean age of children in this study, the range for expected growth velocity is: boys - 3rd percentile = 4.1 cm/year, 50th percentile = 5.8 cm/year, and 97th percentile = 7.5 cm/year; girls - 3rd percentile = 4.3 cm/year, 50th percentile = 5.9 cm/year, and 97th percentile = 7.5 cm/year. The potential reversibility of the reduction in growth velocity was not studied. No significant differences were observed between the 2 groups for mean basal plasma cortisol or ACTH-stimulated plasma cortisol levels.

Geriatric Use

Clinical studies of BECONASE AQ Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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/m2 basis, or approximately 21,000 times the maximum recommended daily intranasal dose in children on a mg/m2 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/m2 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.

ContrainDications

Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism 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 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.

Pharmacokinetics

Absorption: 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 < 50 pg/mL).

Distribution: 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%).

Metabolism: 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.

Elimination: 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.

Pharmacodynamics: 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).

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

BECONASE AQ®
(beclomethasone dipropionate, monohydrate) Nasal Spray, 42 mcg

For Intranasal Use Only.
SHAKE WELL BEFORE USE.

Patient's Instructions for Use

Shake the suspension spray bottle well before using it. Read complete instructions carefully and use only as directed.

To Use:

1. Remove the safety clip and the plastic dust cap from the nasal applicator (Figure 1).

 

Patient's Instructions for Use - Illustration-1

2. The very first time the spray is used, prime the pump into the air by pressing downward on the white collar, using your forefinger and middle finger while supporting the base of the bottle with your thumb. When you prime the pump for the first time, press down and release the pump 6 times or until a fine spray appears (Figure 2).

The pump is now ready for use. If the pump is not used for 7 days, prime until a fine spray appears.

 

Patient's Instructions for Use - Illustration-2

3. Gently blow your nose to clear your nostrils. Close 1 nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (Figure 3).

 

Patient's Instructions for Use - Illustration-3

4. For each spray, press firmly downward once on the white collar, using your forefinger and middle finger while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe gently inward through the nostril.

5. Breathe out through your mouth.

6. Repeat steps 5 through 7 in the other nostril.

7. Replace the plastic dust cap and safety clip.

8. DISCARD THE BOTTLE AFTER the date calculated by your doctor or pharmacist. The correct amount of medication in each spray cannot be assured after 180 sprays even though the bottle is not completely empty. Discard the bottle after 180 sprays. Before the discard date you should consult your doctor to see if a refill is needed. Do not take extra doses or stop taking BECONASE AQ Nasal Spray without consulting your doctor.

Cleansing: To clean the nasal applicator, remove the plastic dust cap and safety clip and then press gently upward on the white collar to free the nasal applicator. Wash the applicator and dust cap with cold water. Dry and replace with the plastic dust cap and safety clip back in position. 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: BECONASE AQ Nasal Spray is not intended to give rapid relief of your nasal symptoms. BECONASE AQ Nasal Spray controls the underlying disorders responsible for your attacks, so it is important that you use it regularly at the times recommended by your doctor. The full benefit of BECONASE AQ Nasal Spray may take a few days to develop.

Storage: Store between 15° and 30°C (59° and 86°F).

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

BECLOMETHASONE - NASAL

 

(BE-kloe-METH-a-sone)

 

COMMON BRAND NAME(S): Beconase Aq, Vancenase Aq

 

USES: Beclomethasone is used to prevent and treat seasonal and year-round allergy symptoms (such as stuffy/runny nose, itchy eyes/nose/throat, sneezing). It is also used to prevent the return of growths in the nose (nasal polyps) after removal by surgery. Beclomethasone belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) in the nasal passages.

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

This medication is for use in the nose, usually 1 or 2 sprays in each nostril twice a day or as directed by your doctor. Avoid spraying this medication in your eyes. Gently blow your nose before using this drug. Shake the container well before each use. Follow the instructions to properly prime the spray pump.

To use the spray, first remove the safety clip and plastic cap. Close one nostril by pressing it with your finger. Tilt your head slightly forward and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril. Press down firmly on the pump to deliver the prescribed number of sprays. Do not spray directly onto the middle wall of your nose (nasal septum). Breathe in gently through your nose and out through your mouth. Repeat in the other nostril. Wipe the applicator tip and replace the plastic cap and safety clip. Avoid blowing your nose for 15 minutes after using this medication.

Dosage is based on your medical condition and response to treatment. Younger children may need a smaller dose and help from an adult to use this medication properly. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose or use it more frequently than directed.

This medication does not work immediately. Some people will feel this medication working within 3 days, but it may take up to 2 weeks before the full benefit of this drug takes effect. Ask your doctor or pharmacist if you should also use other medications (such as nose drops/spray, allergy drugs taken by mouth) along with this drug until it takes full effect.

Keep track of the number of sprays used from the bottle. Discard the bottle after you have used the number of sprays specified on the manufacturer's package. Do not pour any remaining medication into another container. Follow the package instructions to unblock the spray tip if needed and to clean the spray bottle.

Tell your doctor if your condition does not improve after 3 weeks or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Nose/throat dryness or irritation, sneezing, nosebleeds, and unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: loss of taste or smell, pain/sores in your nose.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as beclomethasone). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Beconase-AQ (beclomethasone dipropionate, monohydrate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using nasal beclomethasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as glaucoma, cataracts), infections (including tuberculosis), recent nose problems (such as injury, ulcers, surgery).

Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. However, many doctors consider this drug to be safe to use during pregnancy. Rarely, infants born to mothers who have been using corticosteroids (including beclomethasone) for a long time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Check all prescription medicine labels carefully since similar medications (other corticosteroids such as prednisone) may increase your risk of side effects if taken together with this drug. Ask your doctor or pharmacist if you have any questions about your medications.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

If you use this medication for a long time, laboratory and/or medical tests (such as nose exams, height measurement in children) may be performed to monitor your progress and check for side effects.

Avoid substances (such as pollen, pet dander, dust mites, mold, and smoke) that can worsen allergy symptoms.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) with the safety clip and protective cap in place. Keep container upright. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Beconase AQ, Qnasl

Generic Name: beclomethasone nasal (Pronunciation: BE kloe METH a sone)

  • What is beclomethasone nasal (Beconase-AQ)?
  • What are the possible side effects of beclomethasone nasal (Beconase-AQ)?
  • What is the most important information I should know about beclomethasone nasal (Beconase-AQ)?
  • What should I discuss with my healthcare provider before using beclomethasone nasal (Beconase-AQ)?
  • How should I use beclomethasone nasal (Beconase-AQ)?
  • What happens if I miss a dose (Beconase-AQ)?
  • What happens if I overdose (Beconase-AQ)?
  • What should I avoid while using beclomethasone nasal (Beconase-AQ)?
  • What other drugs will affect beclomethasone nasal (Beconase-AQ)?
  • Where can I get more information?

What is beclomethasone nasal (Beconase-AQ)?

Beclomethasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Beclomethasone nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. The Beconase brand of this medication is also used to keep nasal polyps from coming back after surgery to remove them.

Beclomethasone may also be used for purposes not listed in this medication guide.

What are the possible side effects of beclomethasone nasal (Beconase-AQ)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe or ongoing nose bleed;
  • sores in the nose that won't heal;
  • wheezing, trouble breathing;
  • blurred vision, eye pain, or seeing halos around lights; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects may include:

  • sneezing, runny or stuffy nose;
  • dryness or irritation in your nose or throat;
  • nausea, headache, feeling light-headed;
  • unpleasant taste or smell;
  • mild itching or rash; or
  • sores or white patches inside or around your nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Beconase-AQ (beclomethasone dipropionate, monohydrate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about beclomethasone nasal (Beconase-AQ)?

Before using beclomethasone, tell your doctor if you have been sick or have had an infection of any kind. Also tell your doctor if you have glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Beclomethasone nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using beclomethasone nasal.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using beclomethasone nasal.

Side Effects Centers
  • Beconase-AQ
  • Beconase

Patient Detailed How Take

What should I discuss with my healthcare provider before using beclomethasone nasal (Beconase-AQ)?

You should not use this medication if you are allergic to beclomethasone.

Before using beclomethasone, tell your doctor if you have been sick or have had an infection of any kind. You may not be able to use beclomethasone nasal until you are well.

To make sure you can safely use beclomethasone, tell your doctor if you have any of these other conditions:

  • glaucoma or cataracts;
  • herpes simplex virus of your eyes;
  • tuberculosis or any other infection or illness;
  • sores or ulcers inside your nose; or
  • if you have recently had injury of or surgery on your nose.

FDA pregnancy category C. It is not known whether beclomethasone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether beclomethasone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using beclomethasone nasal.

Beconase should not be given to a child younger than 6 years old. Qnasl should not be given to a child younger than 12 years old.

How should I use beclomethasone nasal (Beconase-AQ)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe use, and directions for priming and disposal of the nasal spray. Ask your doctor or pharmacist if you have any questions.

The usual dose of Beconase is 1 to 2 sprays into each nostril once per day. Follow your doctor's instructions. Shake the Beconase bottle well just before each use.

The usual dose of Qnasl is 2 sprays into each nostril once per day. Follow your doctor's instructions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store in an upright position at room temperature, away from moisture and heat.

Throw away the Beconase nasal spray after you have used 180 sprays, even if there is still medicine left in the bottle.

Throw away the Qnasl nasal spray after you have used 120 sprays, or if the dose indicator shows a zero.

Side Effects Centers
  • Beconase-AQ
  • Beconase

Patient Detailed Avoid Taking

What happens if I miss a dose (Beconase-AQ)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Beconase-AQ)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of beclomethasone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using beclomethasone nasal (Beconase-AQ)?

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Beclomethasone nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using beclomethasone nasal.

What other drugs will affect beclomethasone nasal (Beconase-AQ)?

There may be other drugs that can interact with beclomethasone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about beclomethasone nasal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.01. Revision date: 5/14/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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