Budesonide and Formoterol Oral Inhalation

The combination of budesonide and formoterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by asthma in adults and children 6 years of age and older. The combination of budesonide and formoterol is also used to treat chronic obstructive pulmonary (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema) in adults. Budesonide is in a class of medications called steroids. It works by reducing swelling in the airways. Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

The combination of budesonide and formoterol comes as an aerosol to inhale by mouth using an inhaler. It is usually taken as 2 puffs twice a day, in the morning and the evening, about 12 hours apart. Inhale budesonide and formoterol at about the same times 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 and formoterol 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 take your other oral or inhaled medications for asthma during your treatment with budesonide and formoterol inhalation. If you were using a short-acting beta agonist inhaler such as albuterol (Proair, Proventil, Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications or stop taking any of your medications without talking to your doctor.

Do not use budesonide and formoterol inhalation during an attack of asthma or COPD. Your doctor will prescribe a short-acting (rescue) inhaler to use during attacks. Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of asthma or COPD more often, or if your short-acting inhaler does not relieve your symptoms.

Budesonide and formoterol controls symptoms of asthma and COPD but does not cure them. Continue to use budesonide and formoterol even if you feel well. Do not stop using budesonide and formoterol without talking to your doctor. If you stop using budesonide and formoterol inhalation, your symptoms may return.

If your child will be using the inhaler, be sure that they know how to use it. Watch your child each time they use the inhaler to be sure that they are using it correctly.

Before you use the budesonide and formoterol inhaler the first time, read the written instructions 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 while they watch you so you are sure you are doing it the right way.

After inhalation, rinse your mouth with water and spit the water out; do not swallow the water.

Stop using the inhaler and throw the inhaler away when the dose counter shows zero.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using budesonide and formoterol inhalation,

• tell your doctor and pharmacist if you are allergic to budesonide (Ortikos, Pulmicort, Rhinocort, Tarpeyo, others), formoterol (Perforomist, in Bevespi, in Duaklir Pressair, in Dulera), any other medications, or any of the ingredients in budesonide and formoterol oral inhalation. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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 an irregular heartbeat, QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), heart disease, high blood pressure, low levels of potassium in your blood, diabetes, seizures, 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 thyroid or liver disease. Also tell your doctor if you have any condition that affects your immune system, 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), if you smoke or use tobacco products, or if you are on bedrest or unable to move around.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using budesonide and formoterol inhalation, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using budesonide and formoterol inhalation.
• tell your doctor if you have never had chickenpox or measles and 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 these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.
• you should know that budesonide and formoterol 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 and formoterol inhalation again unless your doctor tells you that you should.

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

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

If you are using budesonide and formoterol inhalation (Symbicort Aerosphere), inhale 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 inhale a double dose to make up for a missed one.

Budesonide and formoterol inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• throat irritation or pain
• stuffy or runny nose
• back pain
• headache
• muscle spasms
• hoarseness
• uncontrollable shaking of a part of the body
• nervousness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives or rash
• swelling of the face, throat, tongue, lips, hands, feet, ankles, or lower legs
• burning, tingling, or numbness in the hands or feet
• white spots or sores in the mouth or throat
• pounding, fast, or irregular heartbeat
• fainting
• chest pain
• tiredness
• nausea
• vomiting
• weakness
• cough, difficulty breathing, or change in the color of sputum (the mucus you may cough up)
• fever, chills, body aches, and other signs of infection

Budesonide and formoterol may cause children to grow more slowly. Your child's doctor will monitor your child's growth carefully. Talk to your child's doctor about the risks of giving this medication to your child.

Budesonide and formoterol may increase the risk that you will develop glaucoma or cataracts. You will probably need to have regular eye exams during your treatment with budesonide and formoterol. Tell your doctor if you have any of the following: pain, redness, or discomfort of the eyes; blurred vision; seeing halos or bright colors around lights; or any other changes in vision. Talk to your doctor about the risks of using this medication.

Budesonide and formoterol may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using this medication.

Budesonide and formoterol may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

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 sunlight, excess heat and moisture (not in the bathroom). Dispose of the inhaler 3 months after you remove it from the foil overwrap or when the dose indicator reads 0), whichever comes first.

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• seizures
• chest pain
• dizziness
• fast, pounding, or irregular heartbeat
• nervousness
• headache
• shaking of a part of your body that you cannot control
• muscle cramps or weakness
• dry mouth
• nausea
• excessive tiredness
• lack of energy
• difficulty falling asleep or staying asleep

Keep all appointments with your doctor.

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.

• Breyna^®

• Breztri^® Aerosphere^® (containing Glycopyrrolate, Budesonide, Formoterol)
• Symbicort^®
• Symbicort^® Aerosphere^®