Pulmicort Flexhaler
Pulmicort Flexhaler
Budesonide
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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.

Indications

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.

Dosage

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.

Immunosuppression

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

Special Populations

Children

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.

Pregnancy

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.

Breastfeeding

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.

Side Effects

Common side effects of Pulmicort Flexhaler include:

  • Thrush in the mouth and throat (Candida albicans)
  • Sinusitis
  • Headaches
  • Back pain
  • Fever
  • 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
  • Anaphylaxis

Drug Interactions

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

Pulmicort Flexhaler is manufactured as a dry powder that contains budesonide. It comes in two strengths: 90 mcg and 180 mcg. Each inhaler can deliver 60 or 120 doses.

Pulmicort Flexhaler is usually started at a dose of 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. This may be increased to a maximum of 360 mcg taken twice a day.

The Pulmicort Flexhaler must first be primed before you use it. Hold the unit at the bottom on the brown grip and point the white cover upward. Use your other hand to lift off the white cap. Twist the brown grip firmly in one direction, as far as it will go, and then turn it back to the original position. It does not matter which way you choose to turn it first. As you do this, you will hear a click. Repeat the twisting action. Once you hear a second click, you have competed priming the unit. You never need to prime the unit again, even if it is not used for a long time.

When using Pulmicort Flexhaler, hold the unit with the brown grip at the bottom and the white mouthpiece at the top. Twist the brown grip firmly in one direction, as far as it will go, and then turn it back to the original position. It does not matter which way you choose to turn it first. As you do this, you will hear a click. The unit is now loaded with one dose.

Take a breath in, and then blow it out. Put the mouthpiece into your mouth and wrap your lips around it. Take a deep hard breath in through the inhaler. You might not feel that any medication is being inhaled, but this does not mean you have not received a dose. Do not repeat an inhalation. Take the mouthpiece out of your mouth and breath normally. If you need a second dose, repeat the steps as described above.

It is important to rinse your mouth out once you have inhaled your dose. This is to prevent you from developing thrush in your mouth and throat. Make sure that you do not swallow the water.

If you miss a dose of Pulmicort Flexhaler, try to take it as soon as possible, then continue with the usual medication schedule. However, if you are due to take your next dose in less than 3 hours, skip the dose you missed and continue with your regular medication schedule. Under no circumstances should you take a double dose of the medication to make up for the missed dose. If you are unsure about what to do, contact your doctor or local pharmacist to obtain advice.

Pulmicort Flexhaler is an inhaled corticosteroid. The most common side effect is related to the steroid’s immunosupperion effect, which can cause thrush in the mouth and throat. This is generally easily treated by your doctor. Other side effects include:

  • sinusitis
  • headaches
  • back pain
  • fever
  • chest infection
  • changes in voice
  • changes in taste
  • difficulty sleeping

Some side effects can be severe and require medical attention. Contact your doctor immediately if you notice any of the following:

  • worsening of your asthma
    • difficulty breathing
    • shortness of breath
    • tight chest
  • changes in your vision
  • swelling of your face with a skin rash
  • acute confusion or aggression
  • development of a temperature or other signs of an infection

If you experience severe side effects, immediately contact your doctor or go to the nearest emergency health care facility.

 

Pulmicort Flexhaler should be stored away from children. It should be stored in a dry place at room temperature and with the cover in place.