Budesonide (bue-DES-oh-nide), Formoterol Fumarate (for-MOE-ter-ol FUE-ma-rate), Glycopyrrolate (glye-koe-PIR-oh-late)

Treats chronic obstructive pulmonary disease (COPD). This medicine contains a bronchodilator and corticosteroid.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Aerosol

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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). Use this medicine at the same time every day. Do not use more medicine or use it more often than instructed.
• Prime the 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.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water after rinsing.
• Clean the inhaler once a week. Remove the canister and rinse the actuator in warm water for about 30 seconds. Turn the actuator upside down and rinse again for about 30 seconds. Let the actuator air dry overnight. Do not put the canister back into the actuator if it is still wet.
• The dose display window of the inhaler will turn red when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 weeks (for the 28 inhalation canister) or 3 months (for the 120 inhalation canister) since you last opened the foil pouch.
• 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.
• 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.

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/glycopyrrolate/formoterol works. Tell your doctor if you are using any of the following:
  • Aclidinium, aminophylline, atropine, ipratropium, nefazodone, theophylline, tiotropium, umeclidinium
  • 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, ketoconazole, telithromycin)
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease (including high blood pressure, heart rhythm problems), diabetes, any kind of infection (including tuberculosis or herpes infection of the eye), eye problems (including cataracts or glaucoma), electrolyte imbalance, an enlarged prostate, bladder problems, trouble passing urine, thyroid problems, seizures, or a history of osteoporosis. Tell your doctor if you have ever been exposed to chickenpox or measles or if you have had surgery.
• 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 patients with 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
  • 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.
• 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, trouble breathing, tightness in the chest, worsening of breathing problems
• Color changes on the skin, dark freckles, easy bruising, muscle weakness, round or puffy face
• Decrease in how much or how often you urinate, difficult or painful urination
• Dizziness, lightheadedness, or fainting
• Dry mouth, increased thirst or hunger, muscle cramps, weight loss
• Eye pain or vision changes
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Seizures, tremors, nervousness, shaking
• Tiredness, weakness, nausea, vomiting

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

• Back pain
• Diarrhea
• 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