Manufacturer:
AstraZeneca Canada Inc.

Generic Name:
budesonide

Route:
oral inhalation

Why is it prescribed?

Pulmicort® nebuamp contains budesonide.

Budesonide is indicated for the prevention, and reduction of severity of asthma symptoms that are responsive to orally inhaled corticosteroids. It is also used intranasally to relieve nasal congestion in the treatment of seasonal and perennial rhinitis (runny nose) where inflammation of the lining of the nose causes it to run. Budesonide nasal preparations are also used in the treatment of nasal polyps and prevention of nasal polyps after surgical removal.

Side Effects

Pulmicort® nebuamp contains budesonide.

Along with its needed effects, budesonide may cause some unwanted or undesirable effects. Generally, budesonide 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:

• 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 Pulmicort® nebuamp

Pulmicort® nebuamp contains budesonide

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 2 weeks of continuous therapy of the inhaler or 2 to 3 days (in rare cases up to 2 weeks) of continuous therapy of the nasal spray.
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 budesonide 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 budesonide 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 budesonide, 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. Budesonide 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 6 years of age

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

Patient Information

Pulmicort® nebuamp are intended for inhalation only, via a nebulizer.
Your doctor, pharmacist or health care provider will instruct you on the proper use and care of the nebulizer. Make sure you understand exactly how to use it before proceeding. Do not use this medication to treat an acute asthma episode. It is not a rescue medication.
It is very important that you use Pulmicort® nebuamp regularly. Depending on the severity of the asthma, it could take several weeks before the full effects of the medication are seen.
Clean and care for your nebulizer according to manufacturer's instructions.
Rinsing the mouth and throat with water after each use will remove any remaining medication to help prevent local yeast (thrush) infections. Cleansing dentures has the same effect. If you use a face mask be sure to wash your face as well. Notify your doctor if a sore throat or mouth occurs or if you suspect a localized yeast infection.
Pulmicort® nebuamp are available in different strengths and each nebuamp contains a specified amount of budesonide. The nebuamps should be stored away from direct sunlight and at room temperature. Once the envelope has been opened, the nebuamps should be used within 3 months.
When only part of an nebuamp is to be used, sterile normal saline should be added to make up the required volume. Opened Nebuamps® must be used within 12 hours.

Directions for Use

The usual starting dose for adults is 1 to 2 mg twice daily. In children 3 months to 12 years of age, the usual starting dose is 0.25 to 0.5 mg twice daily. After the desired effect has been obtained, your doctor may reduce your dose to the smallest amount necessary to control your asthma symptoms.

Lung Diseases Treated with this Drug

• allergic rhinitis
• asthma
• hay fever
• nasal polyps
• 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.