Budesonide (bue-DES-oh-nide), Formoterol Fumarate (for-MOE-ter-ol FUE-ma-rate)

Treats asthma and chronic obstructive pulmonary disease (COPD). Also reduces the worsening attacks of COPD. This medicine contains a bronchodilator and a corticosteroid.

Brand Name(s):

Breyna 160/4.5, Breyna 80/4.5, Symbicort 160/4.5, Symbicort 80/4.5

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Under Pressure, Powder

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Never use more medicine than your doctor prescribed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You will use this medicine with a device called a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and to your lungs. You may be told to use a spacer, which is a tube that is placed between the inhaler and your mouth. Your caregiver will show you how to use your inhaler and the spacer (if needed).
• Prime the Symbicort® inhaler before using it for the first time. Shake well for 5 seconds, then spray into the air, away from your face. Shake and spray a second time. It is now ready for use. If the inhaler has been dropped or has not been used for more than 7 days, prime it again before use.
• Prime the Symbicort Aerosphere® inhaler before using it for the first time. Shake the inhaler and spray the medicine into the air away from your face. Do this 4 times. You will need to re-prime the inhaler after each cleaning and if you have not used it for 7 days or longer, or if you have dropped it. Re-prime the inhaler by shaking and spraying it into the air away from your face 2 times.
• Shake the inhaler well just before each use. Avoid spraying this medicine into your eyes.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down on the top of the canister once.
• Hold your breath for about 5 to 10 seconds, and then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the next puff, starting with shaking the inhaler.
• The dose counter at the top of the inhaler will turn yellow when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water after rinsing.
• Clean the actuator at least once a week with warm water for 30 seconds. Shake off the excess water. Let the actuator air-dry overnight. Do not let the canister get wet.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
• Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty. Store the inhaler with the mouthpiece down.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with other inhaled medicines, including arformoterol, formoterol, indacaterol, olodaterol, salmeterol, or vilanterol.
• Some medicines can affect how budesonide/formoterol works. Tell your doctor if you are using any of the following:
  • Atropine, nefazodone
  • Beta-blocker medicine
  • Diuretic (water pill)
  • Medicine that may cause heart rhythm problems
  • Medicine to treat depression (including an MAO inhibitor, TCAs)
  • Medicine to treat HIV or AIDS (including atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat infection (including clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin)
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart or blood vessel disease, heart rhythm problems, high blood pressure, seizures, thyroid problems, diabetes, any kind of infection (including tuberculosis or herpes infection of the eye), thyroid problems, eye problems (including cataracts or glaucoma), if you have a weak immune system, or a history of osteoporosis. Tell your doctor if you have ever been exposed to chickenpox or measles.
• This medicine may cause the following problems:
  • Increased risk of asthma-related hospital stays, intubations, and death
  • Increased risk of infection, including fungus infection in the mouth (thrush)
  • Increased risk of pneumonia in people who have COPD
  • Adrenal gland problems
  • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
  • Heart rhythm problems
  • Low bone mineral density, which may lead to osteoporosis
  • Slow growth in children
  • Glaucoma or cataracts
  • High blood sugar levels
• Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use your other medicine only during a severe COPD attack.
• Do not use this medicine for a sudden COPD attack, or if symptoms of a COPD attack has already started. Make sure you always have your rescue medicine with you to treat sudden symptoms. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• Call your doctor if your symptoms do not improve or if they get worse.
• You may need to use this medicine for 1 to 2 weeks before your asthma starts to get better.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or tightness, trouble breathing, worsening of breathing problems
• Color changes on the skin, dark freckles, easy bruising, muscle weakness, round or puffy face
• Dry mouth, increased thirst, or muscle cramps
• Eye pain or vision changes
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Tiredness, weakness, nausea, vomiting, dizziness
• Tremors, nervousness, or shaking

If you notice these less serious side effects, talk with your doctor:

• Headache
• Sores or white patches in your mouth or throat, pain when eating or swallowing

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088