Manufacturer:
Apotex Inc.

Generic Name:
beclomethasone dipropionate

Route:
nasal inhalation

Why is it prescribed?

Apo-Beclomethasone® nasal spray contains beclomethasone dipropionate.

Beclomethasone is used to control the signs and symptoms of asthma that are responsive to orally inhaled corticosteroids. It is also used as a nasal spray to relieve stuffiness, sneezing, runny nose, and other symptoms associated with allergies where inflammation of the lining of the nose causes it to run. Beclomethasone nasal spray is also used to slow the rate of recurrence of nasal polyps after surgical removal.

Side Effects

Apo-Beclomethasone® nasal spray contains beclomethasone dipropionate.

Along with its needed effects, beclomethasone dipropionate may cause some unwanted or undesirable effects. Generally, beclomethasone dipropionate is well tolerated and many people will not experience unwanted effects. The severity and duration of these effects are dependant on many factors including duration of therapy, dose, route of administration and individual response. Possible unwanted effects include:

• sneezing attacks immediately after use (nasal spray only)
• irritation and burning in the nose (nasal spray only)
• dry mouth, hoarsness, and loss of voice (oral inhalation only)
• localized infection of Candida Albicans (thrush) of the mouth and throat

• sore throat
• cough
• headache
• dizziness
• nausea
  

• immediate or delayed allergic reaction (e.g. rash, hives, and bronchospasm)
• flushing, itchiness, and swelling of the eyes, face, lips and throat

Precautions and Warnings for Apo-Beclomethasone® nasal spray

Apo-Beclomethasone® nasal spray contains beclomethasone dipropionate

Never use a higher dose than what you have been prescribed. Using higher than recommended doses will cause greater absorption by the body and possibly lead to greater occurrence of unwanted effects. Optimal relief of symptoms may require 1 to 4 weeks of continuous therapy.
If symptoms do not improve or the condition worsens, the doctor should be contacted.
Treatment with beclomethasone should never be stopped without first consulting your doctor.
Discontinuation of beclomethasone requires gradual tapering or you may experience a flare-up of your condition.
Inadequate response can often be a result of improper use of the delivery device. Your doctor or pharmacist should instruct you on the correct use of these preparations. Each product comes with a package insert that should be read and then kept as a reference.
Children using any of these preparations should do so under the direct supervision of an adult who is familiar with it's proper use.
People who are using or who have used beclomethasone or any other corticosteroids should inform their doctor as this may vary the treatment plan.
When people have been treated with oral corticosteroids (e.g. prednisone) for prolonged periods and are being transferred to intranasally or orally inhaled beclomethasone, they may experience withdrawal symptoms (e.g. joint and/or muscular pain, depression). These symptoms should be reported to your doctor, especially if you have associated asthma or another condition in which too rapid a decrease in systemic steroids may cause a severe flare-up of symptoms. Beclomethasone may mask some signs of infection and new infections may appear. The body tends to have a decreased resistance to localized infections while on this therapy, so anything of this nature should be reported to the doctor. Drug Interactions: Due to very low absorption at therapeutic doses it is unlikely that there would be any significant drug interactions. However, it is important to tell your doctor and pharmacist of any prescription or over-the-counter medications you are taking. Use is not recommended in the following situations:

• allergy to beclomethasone dipropionate or any component of the preparation.
• people with tuberculosis
• untreated fungal, bacterial and viral infections
• children under 5 years of age

• people previously treated for prolonged periods with oral corticosteroids e.g. prednisone
  

Patient Information

Apo-Beclomethasone® nasal spray is intended for nasal inhalation only. Your doctor or pharmacist should have instructed you on the proper use and care of your Apo-Beclomethasone® nasal spray. The very first time the spray is used, prime (load) the pump as instructed until a fine spray appears. It is now ready for use.
It is not meant to give you instant relief of your nasal congestion but to correct the underlying problem responsible for your symptoms. Check with the doctor if you notice signs of infection in your nose, throat or sinus or if repeated unusual bleeding occurs.
Remember to shake the bottle before each use.
Your Apo-Beclomethasone® nasal spray should be stored at room temperature (15 to 30 degrees centigrade). Discard 3 months after the first use.

Directions for Use

The usual dose for patients of all ages who received no previous systemic (oral) steroid is 2 applications (100 µg of beclomethasone dipropionate) into each nostril twice daily. Maximum daily dose should not exceed 12 applications (600 µg of beclomethasone dipropionate) in adults and 8 applications (400 µg of beclomethasone) in children. The safety and efficacy of beclomethasone dipropionate aqueous suspension in children under 6 years of age have not been established.

Lung Diseases Treated with this Drug

• allergic rhinitis
• asthma
• chronic bronchitis (COPD)
• COPD
• hay fever
• perennial rhinitis
• rhinitis
• runny nose
• seasonal rhinitis

Need More Information?

For more information contact your physician, pharmacist, other health care professional or for general questions call your local lung association.