Beclomethasone Oral Inhalation

What is Beclomethasone Oral Inhalation?

• Beclomethasone Oral Inhalation (Qvar) is a corticosteroid used as a maintenance treatment for the prevention and control of asthma in people 5 years of age and older.

Beclomethasone

Beclomethasone ball-and-stick

What are the uses of this medicine?

• Beclomethasone Oral Inhalation (Qvar) is an inhaled prescription medicine used as a maintenance treatment for the prevention and control of asthma in people 5 years of age and older.

Limitations of use:

• Qvar is not used to relieve sudden breathing problems (acute bronchospasm).
• It is not known if Qvar is safe and effective in children less than 5 years of age.

How does this medicine work?

• The dipropionate ester of a synthetic glucocorticoid with anti-inflammatory and immunomodulating properties.
• After cell surface receptor attachment and cell entry, beclomethasone enters the nucleus where it binds to and activates specific nuclear receptors, resulting in an altered gene expression and inhibition of proinflammatory cytokine production.
• Corticosteroids have been shown to have multiple anti-inflammatory effects, inhibiting both inflammatory cells (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and release of inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines). These anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Who Should Not Use this medicine ?

This medicine cannot be used:

• to treat sudden severe symptoms of asthma.
• as a rescue inhaler.
• if you are allergic to beclomethasone dipropionate or any of the ingredients in Qvar.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Beclomethasone dipropionate was first patented in 1962 and used medically in 1972.
• It was approved for medical use in the United States in 1976.
• It is on the World Health Organization's List of Essential Medicines.

How should this medicine be used?

Recommended dosage:

• Starting dosage is based on prior asthma therapy and disease severity.
• Treatment of asthma in patients 12 years and older: 40 mcg, 80 mcg, 160 mcg, or 320 mcg twice daily.
• Treatment of asthma in patients 5 to 11 years of age: 40 or 80 mcg twice daily.

Administration:

• Beclomethasone Oral Inhalation (Qvar) comes as an aerosol to inhale by mouth using an inhaler.
• It usually is inhaled twice a day.
• Do not change or stop using Qvar or other asthma medicines used to treat your breathing problems unless your healthcare provider tells you to. Your healthcare provider will change your medicines as needed.
• You must use Qvar regularly. It may take 1 to 4 weeks, or longer, after you start using Qvar for your asthma symptoms to get better. Do not stop using Qvar, even if you are feeling better, unless your healthcare provider tells you to.
• Qvar comes in 2 strengths (40 and 80 mcg). Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between Qvar and your other inhaled medicines, including their prescribed use and the way they look.
• Qvar does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of Qvar. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you.
• Rinse your mouth with water without swallowing after each dose of Qvar. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
• Do not spray Qvar in your face or eyes. If you accidentally get Qvar in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation aerosol: 40 or 80 mcg per actuation

This medicine is available in fallowing brand namesː

• Beclovent
• Qvar
• Vanceril

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• throat irritation (pharyngitis)
• sinus irritation (sinusitis)

Beclomethasone Oral Inhalation may cause serious side effects, including:

• fungal infections (thrush) in your mouth and throat
• worsening asthma or sudden asthma attacks
• adrenal insufficiency
• immune system effects and a higher chance for infections
• bronchospasm
• serious allergic reactions
• slowed growth in children
• lower bone density
• eye problems

What special precautions should I follow?

• Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation.
• Do not use beclomethasone during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Call your doctor if you have an asthma attack that does not stop when using the fast-acting asthma medication, or if you need to use more of the fast-acting medication than usual.
• Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to Qvar.
• Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections.
• Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat bronchospasm immediately with inhaled, short-acting bronchodilator and discontinue Qvar.
• Hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm may occur. Discontinue Qvar if such reactions occur.
• Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Qvar slowly.
• Orally inhaled corticosteroids, including Qvar, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Qvar routinely (e.g., via stadiometry).
• Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Monitor patients with major risk factors for decreased bone mineral content.
• Glaucoma, increased intraocular pressure, blurred vision and cataracts have been reported following the use of long-term administration of inhaled corticosteroids. Monitor patients with change in vision or with a history of increased intraocular pressure, blurred vision, glaucoma, and/or cataracts closely.
• Warn persons who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex
• Advise patients to use Qvar at regular intervals, since its effectiveness depends on regular use. Maximum benefit may not be achieved for 1 week or longer after starting treatment. If symptoms do not improve after 2 weeks of therapy or if the condition worsens, patients should be instructed to contact their physician.
• Do not stop Qvar use abruptly. Instruct the patient to contact their healthcare provider immediately if use of Qvar is discontinued.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with Qvar or beclomethasone dipropionate in pregnant women.
• Thus, available human data do not establish the presence or absence of drug-associated risk to the fetus.

Can this medicine be used in children?

• It is not known if Qvar is safe and effective in children less than 5 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: beclomethasone dipropionate
• Inactive ingredients: propellant HFA-134a and ethanol

Who manufactures and distributes this medicine?

Marketed By:

• Teva Respiratory, LLC
• Frazer, PA

Developed And Manufactured By:

• 3M Drug Delivery Systems AND/OR 3M Health Care, Ltd.
• Northridge, CA Loughborough, UK

• Qvar is a registered trademark of IVAX LLC, a member of the TEVA Group.

What should I know about storage and disposal of this medication?

• Store at 25ºC (77ºF).

• Dailymed label info on Beclomethasone Oral Inhalation
• FDA Beclomethasone Oral Inhalation

Beclomethasone Oral Inhalation Resources
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