Frequently asked questions—About PULMICORT RESPULES

The medicine in PULMICORT RESPULES is a corticosteroid called budesonide (pronounced bew-des-ah-nide). This type of medicine works to reduce existing inflammation and prevent it from getting worse, thereby reducing asthma symptoms and attacks. Corticosteroids are similar to cortisol; a natural substance found in the body that helps fight inflammation.

Corticosteroids are NOT the same as anabolic steroids. Many people are unaware that there are several types of steroids. Anabolic steroids have been misused by athletes to build muscles and improve performance. Corticosteroids, like the budesonide in PULMICORT RESPULES, work very differently and should not be confused with anabolic steroids. Talk to your child's health care provider if you have any questions regarding the different kinds of steroids.

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When used as directed by your child's health care provider, PULMICORT RESPULES can improve asthma symptoms within 2 to 8 days of beginning treatment. Remember, its effectiveness depends on regular use. PULMICORT RESPULES is a preventive (not quick-relief) medicine so it may take 4 to 6 weeks for your child to notice the greatest benefit. For best results it is very important to use PULMICORT RESPULES daily. If your child's symptoms have not improved or your child's condition worsens at any time, contact your child's heath care provider.

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Remember, if your child has asthma, he or she always has some amount of inflammation in the lungs. Even if your child feels better it is important to continue using PULMICORT RESPULES as directed by your doctor. PULMICORT RESPULES treats the inflammation or "quiet part" of asthma that your child cannot hear, see, or feel. When left untreated the underlying inflammation can get worse. When taken every day PULMICORT RESPULES works to reduce and help prevent these asthma symptoms and attacks by keeping the inflammation in the lungs down.

Do not reduce the dose or stop giving PULMICORT RESPULES to your child unless directed by your child's health care provider.

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PULMICORT RESPULES is a controller (preventive or maintenance) medicine that treats the inflammation that causes asthma symptoms. It’s intended to be used regularly to help prevent symptoms and attacks.

Your child's health care provider will tell you when your child should stop taking PULMICORT RESPULES.

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PULMICORT RESPULES should be stored at room temperature, in an upright position, away from light. Be sure to place all unopened RESPULES ampules back in the aluminum foil envelope before storing, to protect the medicine from exposure to light. When one of the aluminum foil envelopes has been opened, all of the RESPULES in it should be used within 2 weeks. Any opened RESPULE must be used right away.

Please keep PULMICORT RESPULES, like all medicines, out of the reach of children. Do not refrigerate, freeze, or heat PULMICORT RESPULES. (Remember: When traveling do not leave PULMICORT RESPULES in your car because the medicine may become too warm or too cold.)

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When it comes to asthma, it’s very important to follow the doctor’s instructions so if your child’s doctor has prescribed PULMICORT RESPULES to be used daily, you should plan to continue your routine even while camping. Also remember that during this trip your child may be exposed to more triggers than what he experiences at home, such as greater amounts of tree pollen, campfire smoke, or dust. Therefore, it’s even more important that you stick to your routine and do everything you can to help prevent his asthma symptoms. You might want to speak to your child’s doctor about battery-operated nebulizers. Also remember to bring his rescue medicine, in case he experiences sudden symptoms.

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Use PULMICORT RESPULES only as directed by your child's health care provider.

PULMICORT RESPULES is given using a jet nebulizer—a type of misting machine for medicines. It uses air pressure to turn the liquid medicine into a mist that is then inhaled through a facemask or a mouthpiece. Use PULMICORT RESPULES and a jet nebulizer as directed, even during symptom-free periods.

PULMICORT RESPULES should not be used in ultrasonic nebulizers, which work differently than jet nebulizers. Please see the packaging or instructions supplied with your child's nebulizer to make sure that it is a jet and not an ultrasonic nebulizer.

Before using PULMICORT RESPULES read all of the instructions for your child's nebulizer. If you have any questions about how the nebulizer or compressor works contact the manufacturer.

For more information go to How to Use PULMICORT RESPULES.

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Before using PULMICORT RESPULES, read all of the instructions for your child's nebulizer. If you have any questions about how the nebulizer or compressor works, contact the manufacturer. Click here to watch a video which will show you the components of the jet nebulizer and how they work.

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The effects of mixing PULMICORT RESPULES with other nebulized medications have not been adequately assessed. PULMICORT RESPULES should be administered separately in the nebulizer.

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As with most medicines there are some side effects associated with PULMICORT RESPULES. In studies, side effects included respiratory infection, runny nose, earache, and coughing. If switching to PULMICORT RESPULES from an oral (syrup or pill) corticosteroid, follow the doctor’s instructions to help avoid health risks. Tell the doctor if your child is exposed to chicken pox or measles.

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Inhaled corticosteroids may cause a reduction in how quickly your child’s height increases. The long-term effect on final adult height is not known. However, poorly controlled asthma itself may pose a risk of delayed growth.

The National Institutes of Health4 (NIH) has developed guidelines to help physicians manage asthma. These guidelines may be considered together with other information by your child's doctor to determine individual patient treatment needs. For patients who need a controller medication for persistent asthma, the NIH guidelines recommend inhaled corticosteroids as the preferred therapy. PULMICORT RESPULES is an example of an inhaled corticosteroid.

Once your child’s asthma stabilizes and remains consistently controlled, your child's health care provider will make sure he or she receives the lowest possible dose of inhaled corticosteroid to help minimize the risk of side effects. Your child's health care provider will also regularly check your child's growth and compare the risk of growth reduction with the benefits of taking a daily preventive asthma medication.

For more information on long-term effects, click here for full Prescribing Information.

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PULMICORT RESPULES is developed and approved specifically for children 12 months to 8 years of age, to help prevent asthma symptoms that could lead to an attack. PULMICORT RESPULES, an inhaled corticosteroid, is not a quick-relief medication and should NOT be used to treat an acute (sudden) asthma attack.

Important Safety Information you should know

PULMICORT RESPULES, an inhaled corticosteroid, is not a quick-relief medication and should NOT be used to treat an acute asthma attack. In studies, side effects included respiratory infection, runny nose, earache, and coughing. Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown. If switching to PULMICORT RESPULES from an oral (syrup or pill) corticosteroid, follow the doctor's instructions to help avoid health risks. Tell the doctor if your child is exposed to chicken pox or measles.

Click here for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

References

  1. Agertoft L, Pedersen, S. Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med. 2000; 343:1064-9.
  2. Scott MB, Skoner DP. Short-term and long-term safety of budesonide inhalation suspension in infants and young children with persistent asthma. J Allergy Clin Immunol. 1999;104:200-209.
  3. American Academy of Allergy & Immunology. Tips to Remember: Asthma triggers and management. Available at: http://www.aaaai.org/patients/publicedmat/tips/
    asthmatriggersandmgmt.stm    . Accessed October 20, 2006.
  4. National Asthma Education and Prevention Program Clinical Practice Guidelines: Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma, published by the National Institutes of Health, and the National Heart, Lung, and Blood Institute, 1997; NIH Publication No. 97-4051.