PULMICORT RESPULES — a type of asthma treatment called an inhaled corticosteroid (ICS) — is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
The good news is that regular use of PULMICORT RESPULES can help improve your child's asthma symptoms.
PULMICORT RESPULES was designed to be delivered through a jet nebulizer connected to an air compressor with an adequate flow, which turns the asthma medication into a fine mist that your child simply breathes in through a face mask or mouthpiece. And it delivers PULMICORT RESPULES to your child's lungs, where it's needed. Do not use an ultrasonic nebulizer.
PARI JET PLUS® Nebulizers and PARI MASTER® Compressors were used in controlled clinical studies. Although PULMICORT RESPULES has been used in other jet nebulizers, the safety and efficacy of PULMICORT RESPULES have not been established using those systems.
IMPORTANT INFORMATION ABOUT PULMICORT RESPULES
Important Safety Information
PULMICORT RESPULES is not a bronchodilator and should NOT be used
to treat an acute asthma attack. If your child is switching to PULMICORT
RESPULES from an oral corticosteroid, follow the doctor's instructions
to avoid serious health risks when your child stops using oral corticosteroids.
Only use PULMICORT RESPULES with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.
Thrush infection of the mouth and throat may occur with PULMICORT RESPULES.
Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.
Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.
PULMICORT RESPULES should not be used if your child is allergic to budesonide or any of the ingredients.
Be sure to tell the healthcare provider about all your child's health conditions and all medicines he or she may be taking.
As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT RESPULES, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT RESPULES should be stopped and your physician consulted.
The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.
Approved Use
PULMICORT RESPULES (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.
Please click here for full Prescribing Information for PULMICORT RESPULES. 
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.