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Pulmicort® nebuamp

This product is manufactured by AstraZeneca Canada Inc. using the ingredient budesonide.

This product is taken via nebulizer.

Why is it prescribed?

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.

Pulmicort® nebuamps 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.

Directions for use:
1.Remove 1 nebuamp from a sheet of 5 units. Return the other units to the envelope. 
2.Gently shake the unit.
3.Open by holding the unit upright and twisting off the top “wing”. 
4.Slowly squeeze the contents of the unit into the nebulizer cup. If you only need to use half the contents of a unit, add sterile saline to the cup as instructed by your doctor or pharmacist. Before you use the rest of the unit for the next dose, swirl it gently. 
5.Connect one end of the cup to the face mask or mouthpiece, and the other end to the air pump. 
6.Just before you start treatment, gently shake the contents of the cup again. Then start the treatment. 
7.Breathe calmly and evenly until no more mist comes out (about 10-15 minutes). 
8.Rinse your mouth and spit out as soon as you are done.
9.If you use a face mask, wash your face after treatment


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.


Alternatives

Other products that have the same ingredient as Pulmicort® nebuamp are •Breztri™ Aerosphere® •Mylan-Budesonide aqueous nasal spray •Pulmicort® Turbuhaler®  •Rhinocort® aqua nasal spray •Symbicort® Turbuhaler® •Taro-Budesonide inhalation solution •Teva-Budesonide inhalation solution •

See other products used in the treatment of •allergic rhinitis •asthma •hay fever •nasal polyps •perennial rhinitis •rhinitis •runny nose •seasonal rhinitis •chronic bronchitis (COPD) •COPD •emphysema (COPD) •

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.


Budesonide is a corticosteroid that possesses potent anti-inflammatory activity. Whether inhaled through the nose or into the lungs, the effect of the drug is local (acting directly on the tissue it comes in contact with). The amount absorbed by the body is minimal and therefore the incidence of unwanted effects is low.


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


Less common:

  • sore throat
  • cough
  • headache
  • dizziness
  • nausea

Rare:

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

 


  • 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 budesonide 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 its proper use.
  • People who are using or who have used budesonide or any other corticosteroids should inform their doctor as this may change 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 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

Caution recommended in the following situations:

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

Use in pregnancy: Inhaled budesonide would likely not result in significant absorption, and therefore, is generally considered compatible with pregnancy.  Consult your doctor or pharmacist before using.

Use while breast-feeding:  Levels in breast milk are very minimal - no untoward effects in infant are expected.