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Glycopyrrolate/Formoterol (Inhalation) (Aerosol)

Glycopyrrolate/Formoterol (By breathing)
Formoterol Fumarate (for-MOE-ter-ol FUE-ma-rate), Glycopyrrolate (glye-koe-PIR-oh-late)Treats chronic obstructive pulmonary disease (COPD).Brand Name(s):
There may be other brand names for this medicine.

When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to glycopyrrolate or formoterol.

How to Use This Medicine:
Aerosol

  • 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.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
  • 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.
  • 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.

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 this medicine works. Tell your doctor if you are using any of the following:
    • Beta-blocker medicine
    • Diuretic (water pill)
    • MAO inhibitor
    • Steroid (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
    • TCA medicine for depression

Warnings While Using This Medicine:

  • Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, asthma, diabetes, glaucoma, heart disease, high blood pressure, heart rhythm problems (such as QT prolongation), an overactive thyroid, prostate problems, trouble urinating, or a history of seizures.
  • This medicine may cause the following problems:
    • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
    • Heart rhythm changes
    • Low potassium or high blood sugar levels in the blood
  • Do not use this medicine for a sudden COPD attack. 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.
  • 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
  • Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
  • Increased hunger or thirst
  • Increased trouble breathing

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