Pulmicort Flexhaler (Budesonide)
What is the Pulmicort Flexhaler?
Pulmicort Flexhaler (budesonide) is a prescription corticosteroid that is inhaled into the lungs for the treatment of asthma.
How does the Pulmicort Flexhaler work?
Pulmicort Flexhaler is a dry powder corticosteroid that is breathed into the lungs using an inhaler. It settles into the lung tissue, suppressing the chronic inflammation caused by asthma.
Pulmicort Flexhaler is indicated for the treatment of patients with persistent asthma. It works to prevent and control shortness of breath and wheezing caused by asthma. It must be used regularly (for at least two weeks) before any effect is seen. Its slow onset of action means that it should not be used to treat acute asthma.
The dose of Pulmicort Flexhaler is 360 mcg taken twice a day. In some patients, the starting dose may be 180 mcg taken twice a day. The dose may be increased every two weeks if there is an insufficient clinical response to the starting dose. The maximum dose is 720 mcg taken twice daily. In patients between 12 and 18 years of age, the starting dose is 180 mcg taken twice a day. The dose may be increased to a maximum of 360 mcg taken twice a day.
Warnings & Precautions
Local effects on the mouth and throat
Pulmicort Flexhaler is a steroid that may cause the development of thrush (Candida Albicans) in the mouth and throat. Patients should rinse their mouths with water after inhaling their doses to prevent this from developing. Monitor patients regularly for the development of thrush.
Acute asthmatic deterioration
Pulmicort Flexhaler should not be used for the management of acute asthmatic deterioration. It has no intrinsic bronchodilatory effects and using it during an acute asthmatic deterioration will not help to relieve any symptoms.
Pulmicort Flexhaler is a corticosteroid that causes mild suppression of the immune system. This may worsen existing bacterial, fungal, or viral infections. Patients with tuberculosis, herpes simplex, measles or chickenpox can be seriously affected.
Transferring from oral steroids to Pulmicort Flexhaler
Pulmicort Flexhaler delivers steroids directly to the lung. As a result, there is a lower steroid concentration in the rest of the body. When transferring from oral steroids to Pulmicort Flexhaler, there is a risk that the body will have insufficient levels of corticosteroid available, leading to a clinical picture of adrenal insufficiency.
Suppression of the adrenal system
Pulmicort Flexhaler results in lower levels of steroids in the rest of the body than when taking oral steroids. However, this lower dose may still be enough to suppress the body’s own production of corticosteroids from the adrenal glands. This may lead to adrenal insufficiency during periods of severe stress where additional corticosteroid is needed or when Pulmicort Flexhaler is suddenly stopped.
Bone mineral density reductions
Patients taking Pulmicort Flexhaler are at risk of having a reduction in their bone density due to the long-term effect of the inhaled steroid. This may increase the risk of developing bone fractures.
Inhibition of growth in children
Children who take Pulmicort Flexhaler are at risk of having a lower growth rate. The lowest dose that can control the patient’s asthma should be used. Children taking Pulmicort Flexhaler should have their growth monitored.
Glaucoma and Cataracts
The long-term use of inhaled steroids can cause an increase in eye pressure (glaucoma). It also increases the long-term risk of developing cataracts.
Eosinophilia and Churg-Strauss Syndrome
Rarely long term inhaled corticosteroids can cause an increase of eosinophils in the body that presents with clinical features consistent with a Churg-Strauss Syndrome vasculitis
Pulmicort Flexhaler has not been tested extensively in persons under six years of age. As a result, its use is not recommended in this age group.
Pulmicort Flexhaler has not been extensively studied in pregnant women. However, some studies have shown that its use does not increase the risk of birth abnormalities. Pregnant women with asthma taking Pulmicort Flexhaler should be monitored closely, and medication adjusted as required.
The safety of Pulmicort Flexhaler has not been tested in breastfeeding mothers. Its active ingredient (budesonide) is found in breastmilk. The risk to the infant should be weighed up against the benefit for the mother. This should be discussed with a doctor.
Common side effects of Pulmicort Flexhaler include:
- Thrush in the mouth and throat (Candida albicans)
- Back pain
- Chest infection
- Changes in voice
- Changes in taste
- Difficulty sleeping
Less common side effects include:
- Suppression of the immune system
- Reduction in bone density
- Inhibition of growth in children
- Glaucoma and cataracts
- Systemic eosinophilia
- Churg-Strauss syndrome
Certain drugs may interact with Pulmicort Flexhaler. These include:
- antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- antiretrovirals (e.g., ritonavir, atazanavir, indinavir)
- antibiotics (e.g., clarithromycin, telithromycin)
- antidepressants (e.g., nefazadone)
Frequently Asked Questions