Brand Name(s):

Pulmicort^® ¶
Pulmicort^® Flexhaler
Pulmicort^® Respules
Symbicort^® (as a combination product containing Budesonide, Formoterol)

WHY is this medicine prescribed?

Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Budesonide powder for oral inhalation (Pulmicort Flexhaler) is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation (Pulmicort Respules) is used in children 12 months to 8 years of age. Budesonide belongs to a class of medications called corticosteroids. It works by decreasing swelling and irritation in the airways to allow for easier breathing.

HOW should this medicine be used?

Budesonide comes as a powder to inhale by mouth using an inhaler and as a suspension to inhale by mouth using a special jet nebulizer (machine that turns medication into a mist that can be inhaled). Budesonide powder for oral inhalation is usually inhaled twice a day. Budesonide suspension for oral inhalation is usually inhaled once or twice a day. Try to use budesonide at around the same time(s) every 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.

Talk to your doctor about how you should use your other oral and inhaled medications for asthma during your treatment with budesonide inhalation. If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos), your doctor may want to gradually decrease your steroid dose starting after you begin to use budesonide.

Budesonide controls symptoms of asthma but does not cure it. Improvement in your asthma may occur as soon after using the medication, but full effects of may not be seen for 1 to 2 weeks after using the powder and 4 to 6 weeks after using the suspension on a regular basis. 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 or your child's symptoms do not improve during the first 2 weeks (powder) or first 6 weeks (suspension) or if they get worse.

Budesonide helps to prevent asthma attacks (sudden episodes of shortness of breath, wheezing, and coughing) but will not stop an asthma attack that has already started. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Tell your doctor if your asthma worsens during your treatment.

Each budesonide inhaler is designed to provide 60 or 120 inhalations, depending on its size. After the labeled number of inhalations has been used, later inhalations may not contain the correct amount of medication. You should keep track of the number of inhalations you have used. You can divide the number of inhalations in your inhaler by the number of inhalations you use each day to find out how many days your inhaler will last. Dispose of the inhaler after you have used the labeled number of inhalations even if it still contains some liquid and continues to release a spray when it is pressed.

Do not swallow budesonide nebulizer suspension.

Before you use budesonide inhaler or jet nebulizer the first time, read the written instructions that come with it. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler or nebulizer. Ask your doctor, pharmacist, or respiratory therapist to show you the right way to use the inhaler or nebulizer. Practice using the inhaler or nebulizer in front of him or her, so you are sure you are doing it the right way.

To inhale the powder using the inhaler, follow these steps:

Turn the protective cover and lift it off.
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.
Holding the inhaler upright, load the first dose by turning the grip fully to the right and fully to the left until it clicks.
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.
Hold the inhaler in the upright (mouthpiece up) or horizontal position. Place the mouthpiece between your lips well into your mouth. Tilt your head slightly back. Close your lips tightly around the mouthpiece, but do not bite or chew the mouthpiece. Inhale deeply and forcefully. Be sure that the mist goes into your throat and is not blocked by your teeth or tongue.
Remove the inhaler from your mouth and hold your breath for about 10 seconds. Do not blow or exhale through the inhaler.
If you are to inhale two puffs, repeat steps 4-6. For the next puff the inhaler 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.
Replace the protective cap on the inhaler and twist it shut.
After each treatment, rinse your mouth with water and spit. Do not swallow the water.
Keep the inhaler clean and dry with the cover tightly in place at all times.

To inhale the suspension using the jet nebulizer, follow these steps:

Remove one ampule of inhalation suspension from the foil pouch.
Gently shake the ampule in a circular motion.
Hold the ampule upright and twist off the top of the ampule. Pour all of the liquid into the nebulizer reservoir. Do not mix other medications with budesonide in the reservoir.
Connect the nebulizer reservoir to the mouthpiece or face mask.
Connect the nebulizer to the compressor.
Place the mouthpiece in your child's mouth or use the face mask. Have your child sit in an upright, comfortable position and turn on the compressor.
Tell your child to breathe in calmly, deeply, and evenly until mist stops forming in the chamber.
After each treatment, have your child rinse their mouth with water and spit; do not swallow the water.
Dispose of the empty ampule and its top in a trash can that is out of the reach of children and pets.
Clean your nebulizer regularly. Follow the manufacturer's directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your nebulizer.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before using budesonide inhalation,

tell your doctor and pharmacist if you are allergic to budesonide, any other medications, or any of the ingredients in budesonide inhalation powder or nebulizer solution. If you will be using the inhalation powder, also tell your doctor if you are allergic to milk proteins. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have recently taken. Be sure to mention any of the following: antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin); HIV protease inhibitors such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak, others), and saquinavir (Invirase); medications for seizures, nefazodone; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); and telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with budesonide inhalation, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
do not use budesonide during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Call your doctor if you have an asthma attack that does not stop when using the fast-acting asthma medication, or if you need to use more of the fast-acting medication than usual.
tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become thin and weak and break easily) and if you have or have ever had tuberculosis (TB; a serious lung infection) in your lungs, cataracts (clouding of the lens of the eye), glaucoma (an eye disease) or high pressure in the eye, or liver disease. Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface).
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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 using budesonide.
if you have any other medical conditions, such as asthma, arthritis, or eczema (a skin disease), they may worsen when your oral steroid dose is decreased. Tell your doctor if this happens or if you experience any of the following symptoms during this time: extreme tiredness, muscle weakness or pain; sudden pain in stomach, lower body or legs; loss of appetite; weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of skin. Your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you recently replaced your oral steroid with budesonide inhalation. Carry a card or wear a medical identification bracelet to let emergency personnel know that you may need to be treated with steroids in an emergency.
tell your doctor if you have never had chickenpox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.
you should know that budesonide inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication right away and call your doctor. Do not use budesonide inhalation again unless your doctor tells you that you should.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Some side effects can be serious. If you experience any of the following symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

white spots or sores in your mouth
rash
hives
itching
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
hoarseness
difficulty breathing or swallowing
wheezing
cough
chest pain
anxiety
fever, chills, or other signs of infection
tiredness
nausea
vomiting
weakness
changes in vision

Budesonide inhalation may cause children to grow more slowly. There is not enough information to tell whether using budesonide decreases the final height that children will reach when they stop growing. Your child's doctor will watch your child's growth carefully while your child is using budesonide. Talk to your child's doctor about the risks of giving this medication to your child.

In rare cases, people who used budesonide for a long time developed glaucoma or cataracts. Talk to your doctor about the risks of using budesonide and how often you should have your eyes examined during your treatment.

Budesonide may increase your risk of developing osteoporosis (a condition in which the bones become thin and weak and break easily). Talk to your doctor about the risks of using this medication.

Budesonide inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Keep the nebulizer ampules sealed in their foil pouches until you are ready to use them. Store the inhaler and nebulizer solution at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate or freeze the nebulizer solution. If you are using the inhalation powder, replace your old inhaler each time you refill your prescription. If you are using the nebulizer solution, you must dispose of the ampules if unused 2 weeks after opening the foil pouch.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2015.