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

Treats chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine is a bronchodilator.

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.
• 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.
• You will need to prime the inhaler before you use it for the first time. To do this, 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. Re-prime the inhaler by shaking and spraying it into the air away from your face 2 times.
• 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.
• 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not use 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. Throw the medicine 3 months after you first use it (3 weeks for the 28 inhalation canister) or when the dose indicator reaches zero "0".

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, olodaterol, indacaterol, salmeterol, or vilanterol.
• Some medicines can affect how glycopyrrolate/formoterol works. Tell your doctor if you are using any of the following:
  • Aminophylline, theophylline
  • Beta-blocker medicine
  • Diuretic (water pill)
  • Medicine to treat depression (including an MAO inhibitor, TCAs)
  • Steroid (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

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, high blood pressure, heart rhythm problems (including QT prolongation), diabetes, glaucoma, thyroid problems, prostate problems, trouble urinating, electrolyte imbalance, or seizures.
• This medicine may cause the following problems:
  • Increased risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid
  • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
  • High blood pressure
  • Heart rhythm problems
  • High blood sugar levels
  • Eye or vision problems
• 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.
• 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
• Blurred vision, eye pain, seeing halos around objects
• Chest pain, fast, pounding, or uneven heartbeat
• Decrease in how much or how often you urinate, difficult or painful urination
• Dizziness, lightheadedness, or fainting
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Increased hunger or thirst, weight loss
• Increased troubled breathing
• Seizures or tremors

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