Beconase

The replacement of a systemic corticosteroid with beclomethasone dipropionate nasal inhaler or 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 beclomethasone dipropionate nasal inhaler or 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.

Studies have shown that combined administration of alternate-day prednisone systemic treatment and orally inhaled beclomethasone dipropionate increases the likelihood of HPA suppression compared to a therapeutic dose of either one alone. Therefore, nasal forms of beclomethasone dipropionate should be used with caution in patients already on alternate day prednisone regimens for any disease.

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, acneform lesions, cataracts, and cushingoid features. If such changes occur, this drug should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy.

Persons who are on 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 nonimmune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure of these infectious agents. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk of developing a more severe infection 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 intramuscualr immunoglobulin (IG), may be indicated. (See the respective product information for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, beclomethasone dipropionate intranasal should be discontinued slowly consistent with accepted procedures for discontinuing oral steroid therapy. The oral LD50 of beclomethasone dipropionate is greater that 1 g/kg in rodents. One canister of beclomethasone dipropionate nasal inhaler contains 8.4 mg of beclomethasone dipropionate, and one bottle of beclomethasone dipropionate nasal spray contains beclomethasone dipropionate, monohydrate equivalent to 10.5 mg of beclomethasone dipropionate; therefore, acute overdosage is unlikely.

Beclomethasone 17,21-dipropionate is a diester of beclomethasone, a synthetic halogenated corticosteroid. Animal studies show that beclomethasone dipropionate has potent glucocorticoid and weak mineralocorticoid activity.

The mechanisms responsible for the anti-inflammatory action of beclomethasone dipropionate are unknown. The precise mechanism of the aerosolized drug's action in the nose is also unknown. Biopsies of nasal mucosa obtained during clinical studies showed no histopathologic changes when beclomethasone dipropionate was administered intranasally.The effect 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 which 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 1000 mcg per day for 1 month as an oral aerosol or for 3 days by IM injection. However, partial suppression of plasma cortisol concentration was observed when beclomethasone dipropionate was administered in doses of 2000 mcg per day either by oral aerosol or intramuscular injection form. Immediate suppression of plasma cortisol concentrations was observed after single doses of 4000 mcg of beclomethasone dipropionate. Suppression of HPA function (reduced early morning plasma cortisol levels) has been reported in adult patients who received 1600-mcg daily doses of oral beclomethasone dipropionate for 1 month. In clinical studies using beclomethasone dipropionate intranasally, there was no evidence of adrenal insufficiency.

The effect of beclomethasone dipropionate nasal spray on HPA function was not evaluated but would not be expected to differ from intranasal beclomethasone dipropionate aerosol.

In one study in asthmatic children, 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).

Beclomethasone dipropionate is sparingly soluble. When given by nasal inhalation in the form of an aqueous or aerosolized suspension, the drug is deposited primarily in the nasal passages. A portion of the drug is swallowed. Absorption occurs rapidly from all respiratory and gastrointestinal tissues. There is no evidence of tissue storage of beclomethasone dipropionate or its metabolites. In vitro studies have shown that tissue other than the liver (lung slices) can rapidly metabolize beclomethasone dipropionate to beclomethasone 17- monopropionate and more slowly to free becloethasone (which has very weak anti-inflammatory activity). However, irrespective of the route of entry, the principal route of excretion of the drug and its metabolites is the feces. In humans, 12% to 15% of an orally administered dose of beclomethasone dipropionate is excreted in the urine as both conjugated and free metabolites of the drug.

Studies have shown that the degree of binding to plasma proteins is 87%.

• Altura Pharmaceuticals, Inc.

• Cheshire Pharm. Systems

• DHS, Inc.

• Glaxo SmithKline Pharmaceuticals

• GlaxoSmithKline LLC

• Palmetto State Pharmaceuticals

• Quality Care Pharmaceuticals

• Stat Rx Usa Llc

Beconase is part of the drug classes:

• Corticosteroids acting locally

• Corticosteroids, potent group III

Beclomethasone nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by perennial (year-round) or seasonal hay fever (allergic rhinitis). It is a steroid (cortisone-like medicine) that works by preventing the inflammation that occurs with allergic reactions.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain beclomethasone. It may not be specific to Beconase. Please read with care.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, rinse it off right away and call your doctor.

To use the spray:

• When you use the medicine for the first time or if you have not used this medicine for 7 days in a row, you must prime the spray. Press down fully on the top of the canister four times or until a fine spray comes out.
• After you prime the nasal spray, there will only be 120 doses or sprays.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril.
• Hold your breath for a few seconds then breathe out slowly through your mouth.
• Spray the opposite nostril using the same steps.
• Do not blow your nose after using the spray.
• Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.
• Do not remove the canister from the actuator. Qnasl™ nasal aerosol canister should only be used with the Qnasl™ nasal aerosol actuator.
• Throw this medicine away after you use 120 sprays or when the dose indicator read zero "0".

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For treatment of allergic rhinitis:
    • Adults and children 12 years of age and older—2 sprays in each nostril once a day. Each spray contains 80 micrograms (mcg).
    • Adults and children 4 to 11 years of age—1 spray in each nostril once a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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.

Nasal Inhaler

In general, side effects in clinical studies have been primarily associated with the nasal mucous membranes.

Adverse reactions reported in controlled clinical trials and long-term open studies in patients treated with beclomethasone dipropionate nasal inhaler are described below.

Sensations of irritation and burning in the nose (11 per 100 patients) following the use of beclomethasone dipropionate nasal inhaler have been reported. Also, occasional sneezing attacks (10 per 100 adult patients) have occurred immediately following the use of the intranasal inhaler. This symptom may be more common in children. Rhinorrhea may occur occasionally (1 per 100 patients).

Localized infections of the nose and pharynx with Candida albicans have occurred rarely (see PRECAUTIONS).

Transient episodes of epistaxis have been reported in 2 per 100 patients.

Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported (see PRECAUTIONS).

Reports of headache, light-headedness, 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 intranasal application of aerosolized corticosteroids (see PRECAUTIONS).

Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone.

Systemic corticosteroid side effects were not reported during the controlled clinical trials. If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism (i.e., Cushing's syndrome, could occur).

Nasal Spray

In general, side effects in clinical studies have been primarily associated with irritation of the nasal mucous membranes. Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.

Adverse reactions reported in controlled clinical trials and open studies in patients treated with beclomethasone dipropionate 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 beclomethasone dipropionate 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 (see PRECAUTIONS).

Read the entire FDA prescribing information for Beconase (Beclomethasone Nasal)

Applies to beclomethasone nasal: nasal aerosol with adapter, nasal spray

General

The most commonly reported side effects were epistaxis, nasal discomfort, throat irritation, and headache.[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including anaphylaxis, angioedema, rash, urticaria, and bronchospasm)[Ref]

Respiratory

Common (1% to 10%): Epistaxis, nasal discomfort, sneezing attacks, nasal stuffiness, rhinorrhea
Frequency not reported: Nasal ulcerations, dryness and irritation of the nose and throat
Postmarketing reports: Nasal septal perforation
Rare (less than 0.1%): Wheezing[Ref]

Endocrine

Frequency not reported: Hypercorticism, adrenal suppression, growth reduction in children[Ref]

Gastrointestinal

Common (1% to 10%): Nausea[Ref]

Nervous system

Common (1% to 10%): Headache, lightheadedness
Postmarketing reports: Loss of taste and smell, unpleasant taste and smell[Ref]

Immunologic

Frequency not reported: Candida albicans infection, immunosuppression[Ref]

Ocular

Common (1% to 10%): Tearing eyes
Postmarketing reports: Glaucoma, cataracts
Rare (less than 0.1%): Increased intraocular pressure[Ref]

Other

Frequency not reported: Impaired wound healing[Ref]

Some side effects of Beconase AQ may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.