Medications

Mylan-Budesonide aqueous nasal spray   

This product is manufactured by Mylan using the ingredient budesonide.

This product is taken via nasal inhalation.

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.


Mylan-Budesonide aqueous nasal spray is intended for nasal inhalation only. Your doctor or pharmacist should have instructed you on the proper use and care of your Mylan-Budesonide nasal spray.

1. Invert the bottle gently 10 times. Remove the protective cap from the nasal adapter.
2. When using the spray for the first time, you must load the pump by pressing downwards on the collar (five to ten times) using your index and middle finger while supporting base of the bottle with thumb . Press down until a fine mist spray appears. The spray is now ready for use and will not require reloading unless used infrequently or disassembled.
3. Gently blow your nose.  Tilt your head forward slightly, close one nostril with your finger and gently insert the tip of the nasal adapter into the other nostril. It is important to keep the bottle completely upright during spraying, specially near the end of the spray regime. If leaned to one side or other it becomes possible to get air into the spray chamber thus delivering low dose weights.
4. For each spray your physician has instructed you to take, press firmly downwards once on the collar. Breathe gently inward through the nostril, then breathe out through the mouth.
5. Repeat the procedure for the other nostril.
6. Replace the protective cap on the nasal adapter. Keep the bottle in an upright position. Store at 15° C - 30°C.

The only other time the pump needs priming is when the spray has not been used regularly in which case it needs only 1 spray into the air.
It is not meant to give you instant relief of your nasal congestion but to correct the underlying disorder responsible for your symptoms. It usually takes a few days (in some cases up to 2 weeks) of regular use before you see any improvement. Contact the doctor if there has been no improvement after 3 weeks.

Check with the doctor if the inside of your nose becomes sore, if colored nasal secretions appear or if repeated bleeding occurs.

The nose piece and protective cap should be cleaned regularly according to manufacturer's instructions. 

Side effects may include:

  •  nose and throat irritation
  •  nosebleeds and crusting
  •  itchy and sore throat
  •  cough
  •  headache

 


Alternatives

Other products that have the same ingredient as Mylan-Budesonide aqueous nasal spray are •Pulmicort® nebuamp •Pulmicort® Turbuhaler®  •Rhinocort® aqua nasal spray •Rhinocort® Turbuhaler®  •Symbicort® Turbuhaler® •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 •

Rhinitis: The usual starting dose for adults and children over 6 years old is 2 sprays into each nostril once daily in the morning or 1 spray into each nostril twice daily (morning and evening). The maintenance dose is the lowest effective dose.
Nasal polyps: 1 spray into each nostril twice daily - morning and evening.

The safety and efficacy of budesonide aqueous suspension in children under 6 years of age have not been established.


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.


Page Last Updated: 05/10/2016