Glycopyrrolate (glye-koe-PIR-oh-late), Indacaterol (in-da-KAT-er-ol)

Treats breathing problems caused by chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You will use this medicine with a special inhaler device called the Neohaler®.Do not use the device with any other medicine. Do not swallow the capsule.
• Do not remove the capsule from the blister pack until you are ready to use it. Use the capsule right away once you have opened a blister pack.
• Place the capsule into the chamber at the base of the inhaler. This device opens the capsule and loads the powder medicine from the capsule into the air chamber.
• To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Do not blow into the mouthpiece. Hold the inhaler without touching the buttons on either side of the inhaler. Breathe in rapidly and steadily, as deeply as you can.
• As you breathe in, you should hear the capsule moving inside. You may also taste something sweet. If you do not hear a whirring noise, the capsule may be stuck inside. If this occurs, open the inhaler and gently tap the base of the device. Do not press the side buttons to loosen the capsule.
• Hold your breath for at leas 5 to 10 seconds or for as long as you can, then breathe out. Open the inhaler to see if any powder is left in the capsule. If there is powder left in the capsule, close the inhaler and repeat the steps.
• Remove the empty capsule after taking your dose. Do not store the capsule inside the device.
• Use a new inhaler with each refill of your medicine. Do not use the inhaler with any other medicine.
• You may wipe the device with a clean, dry, lint-free cloth or a clean, dry, soft brush. Keep the inhaler dry.
• 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. Do not use more than 2 capsules in 24 hours.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the capsule in the blister card until you are ready to use it.

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, budesonide/formoterol, formoterol, salmeterol, or vilanterol.
• Some medicines can affect how indacaterol/glycopyrrolate works. Tell your doctor if you are using any of the following:
  • Aminophylline, erythromycin, ketoconazole, ritonavir, theophylline, verapamil
  • 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 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
  • Eye or vision problems
  • 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 if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. Make sure you always have your rescue medicine with you to treat sudden symptoms.
• The powder in the capsule contains trace amounts of milk proteins. Make sure your doctor knows if you have a severe milk protein allergy.
• 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
• 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