Budesonide Inhalation Powder (patient information)

IMPORTANT WARNING
If you are switching (or have recently switched) from an oral corticosteroid such as budesonide, betamethasone, dexamethasone, methylprednisolone, prednisolone, or prednisone to budesonide inhalation and suffer an injury, infection, or a severe asthma attack, take a full dose of the oral corticosteroid (even if you have been gradually decreasing the dose) and call your doctor for more directions.

Always carry an identification card that says you may need supplementary doses of an oral corticosteroid during periods of stress (injuries, infections, and severe asthma attacks). Ask your pharmacist or doctor how to get this card. List your name, medical problems, drugs and dosages, and doctor's name and telephone number on the card. Include the name of the oral corticosteroid and the full dose you took before decreasing it.

Why this medication is prescribed
Budesonide is used to prevent wheezing, shortness of breath, and troubled breathing caused by severe asthma and other lung diseases. It belongs to a class of drugs called corticosteroids.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used
Budesonide comes as a powder to inhale by mouth. Budesonide is usually inhaled once or twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use budesonide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Budesonide controls symptoms of asthma and other lung diseases but does not cure them. Improvement in your asthma may occur as soon as 24 hours after taking the medication, but full effects may not be seen for 1 to 2 weeks after taking it regularly. Continue to use budesonide even if you feel well. Do not stop using budesonide without talking to your doctor. Call your doctor if your symptoms do not improve during the first 2 weeks or if they get worse.

Do not use budesonide for rapid relief of asthma attacks. If you do not have another inhaler for prompt relief of breathing difficulties, ask your doctor to prescribe one. If your doctor has prescribed a bronchodilator (a drug to be inhaled for rapid relief of difficult breathing such as albuterol [Proventil, Ventolin]), use it several minutes before you use your budesonide. This helps the budesonide get into the deeper parts of your lungs. Call your doctor immediately if your asthma is not responding to usual treatment.

Before you use budesonide the first time, read the written directions that come with it. Ask your doctor, pharmacist, or respiratory therapist to show you the right way to use the inhaler. Practice using the inhaler in front of him or her, so you are sure you are doing it the right way.

To use the inhaler, follow these steps:


 * 1) Turn the protective cover and lift it off.
 * 2) The first time you use a new budesonide inhaler you must prime it. To do this, hold the inhaler upright (with mouthpiece up), then twist the brown grip fully to the right as far as it will go, then back again fully to the left. You will hear a click. Repeat. The unit is now primed and ready to load the first dose. You do not have to prime the inhaler again after this, even if you do not use it for a long time.
 * 3) Holding the inhaler upright, load the first dose by turning the grip fully to the right and fully to the left until it clicks.
 * 4) Turn your head away from the inhaler and breathe out. Do not blow or exhale into the inhaler. #Do not shake the inhaler after loading it.
 * 5) Hold the inhaler in the upright (mouthpiece up) or horizontal position. Place the mouthpiece between your lips well into your mouth, past your front teeth. Tilt your head slightly back. #Close your lips tightly around the mouthpiece and inhale deeply and forcefully. Be sure that the mist goes into your throat and is not blocked by your teeth or tongue. Adults giving the treatment to young children may hold the child's nose closed to be sure that the medication goes into the child's throat.
 * 6) Remove the inhaler from your mouth and hold your breath for about 10 seconds. Do not exhale through the inhaler.
 * 7) If you take 2 puffs (inhalations), wait 2 minutes before taking the second puff.
 * 8) For the next puff and all other puffs, you do not have to prime the inhaler. However, it must be loaded in the upright position right before its use. Turn the grip fully to the right and then fully to the left until it clicks.
 * 9) Replace the protective cap on the inhaler. After each treatment, rinse your mouth with water, but do not swallow the water.

Keep the inhaler clean and dry at all times. Do not bite or chew the mouthpiece. Do not use Pulmicort Turbuhaler with a spacer.

Special precautions
Before using budesonide inhalation powder:


 * tell your doctor and pharmacist if you are allergic to budesonide or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially arthritis medications; aspirin; cimetidine (Tagamet); digoxin (Lanoxin); diuretics ('water pills'); estrogen (Premarin); ketoconazole (Nizoral); oral contraceptives (birth control pills); oral corticosteroids; phenobarbital (Donnatal, others); phenytoin (Dilantin); rifampin (Rifadin); theophylline (Theo-Dur); and vitamins or herbal products.
 * if you have a fungal infection (other than on your skin), or any other type of infection, do not use budesonide without talking to your doctor.
 * tell your doctor if you have or have ever had diabetes; thyroid problems; high blood pressure; mental illness; myasthenia gravis; osteoporosis; herpes eye infection; seizures; tuberculosis; ulcers; or liver, kidney, intestinal, or heart disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using budesonide, call your doctor.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking budesonide.
 * avoid exposure to chicken pox and measles. If you are exposed to them while using budesonide, call your doctor. Do not have a vaccination or other immunization unless directed to by your doctor.

Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Minor Side Effects
Budesonide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * dry or irritated mouth or throat
 * cough
 * difficult or painful speech
 * dizziness
 * difficulty falling asleep or staying asleep
 * neck pain
 * stomach pain

Severe Side Effects
If you experience any of the following symptoms, call your doctor immediately:


 * vision problems
 * white spots or sores in your mouth
 * swollen face, lower legs, or ankles
 * cold or infection that lasts a long time
 * muscle weakness
 * increased difficulty in breathing
 * skin rash
 * unusual bleeding or bruising
 * fever
 * sore throat
 * pain during urination
 * muscle aches

If you have been switched from oral corticosteroids to budesonide and are slowly tapering off your dose of the oral medication and you experience any of the following symptoms, call your doctor immediately:


 * joint or muscle pain
 * increased difficulty in breathing
 * tiredness

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Other information
Keep all appointments with your doctor and the laboratory.

If your sputum (the stuff that you cough up during an asthma attack) thickens or changes color from clear white to yellow, green, or gray, call your doctor; these may be signs of an infection.

Only a small amount of the budesonide powder is released into your lungs when you inhale. Therefore, you may not taste or sense the presence of any medication, but the medication will be working in your lungs.

When there are 20 doses left in the budesonide inhaler, a red mark will appear in the indicator window. This is the time to get your budesonide inhaler refilled. When the red mark reaches the bottom of the window, your inhaler is empty. Discard it. (You may still hear a sound if you shake it; this sound is not the medication. It is the drying agent inside the inhaler.)

Breathing or inhalation devices require regular cleaning. Follow the written directions for care and cleaning that comes with the inhaler.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Entocort® EC
 * Pulmicort® Respules®
 * Pulmicort® Turbuhaler®
 * Pulmicort®Respules®