glycopyrrolate and indacaterol (inhalation)

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Pronunciation: GLYE koe PIR oh late and IN da KA ter ol

Brand: Utibron Neohaler

What is the most important information I should know about glycopyrrolate and indacaterol?

You should not use this medicine if you are allergic to glycopyrrolate or indacaterol.

Glycopyrrolate and indacaterol is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Indacaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Glycopyrrolate and indacaterol is not for use in treating asthma.

What is glycopyrrolate and indacaterol?

Glycopyrrolate is an anticholinergic. Indacaterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.

Glycopyrrolate and indacaterol is a combination medicine used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).

This medicine is not for use in treating asthma.

Indacaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risk.

Glycopyrrolate and indacaterol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using glycopyrrolate and indacaterol?

You should not use this medicine if you are allergic to glycopyrrolate, indacaterol, or milk proteins. Glycopyrrolate and indacaterol is for use only in people with COPD and should not be used to treat asthma.

To make sure glycopyrrolate and indacaterol is safe for you, tell your doctor if you have:

  • heart disease;
  • high blood pressure;
  • liver or kidney disease;
  • narrow-angle glaucoma;
  • an enlarged prostate;
  • a bladder obstruction or other urination problems;
  • diabetes;
  • a thyroid disorder;
  • seizures; or
  • allergy to milk proteins.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether glycopyrrolate and indacaterol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Glycopyrrolate and indacaterol is not approved for use by anyone younger than 18 years old.

How should I use glycopyrrolate and indacaterol?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Glycopyrrolate and indacaterol inhalation powder (Utibron Neohaler) is packaged in capsules that come with a special inhaler device. Each time you use the medicine, load a capsule into the device and click the mouthpiece closed. Push the buttons on the side of the device to pierce the capsule and release the medicine into the inhalation chamber. You may need 2 inhalations to get the full dose from 1 capsule.

Do not swallow the Utibron capsule or place it in your mouth. The capsule is for use only with the Neohaler inhalation device.

The usual dose of this medicine is 1 capsule twice daily. Follow your doctor's dosing instructions very carefully.

Use this medicine at the same time each day, even if you feel well.

Glycopyrrolate and indacaterol is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Use only a fast-acting inhalation medicine for a sudden attack. Tell your doctor if any of your medicines seem to stop working as well in controlling your COPD.

Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly.

Use glycopyrrolate and indacaterol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Always use the new Neohaler device that comes with this medicine.

You should not stop using glycopyrrolate and indacaterol unless your doctor tells you to. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture and heat. Keep the capsules in the blister pack until it is time for your dose. Remove only one capsule each time you use the medicine. Do not push a capsule through the foil or you may damage the capsule.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use more than 2 capsules in one 24-hour period.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include blurred vision, chest pain, fast or pounding heartbeats, severe headache, tremors, muscle cramps, vomiting, little or no urination, drowsiness, or feeling restless.

What should I avoid while using glycopyrrolate and indacaterol?

Do not use a second inhaled bronchodilator unless your doctor has told you to. This includes indacaterol (Arcapta), formoterol or arformoterol (Dulera, Foradil, Perforomist, Symbicort, Brovana), olodaterol (Stiolto, Striverdi), salmeterol (Advair, Serevent), vilanterol (Breo Ellipta), and others.

What are the possible side effects of glycopyrrolate and indacaterol?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • pounding heartbeats or fluttering in your chest;
  • blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
  • painful or difficult urination;
  • low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling;
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
  • worsening of your condition.

Common side effects may include:

  • back pain;
  • stuffy nose, sore throat; or
  • increased blood pressure --headache, pounding in your neck or ears, nosebleeds.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect glycopyrrolate and indacaterol?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • a bronchodilator such as aclidinium, ipratropium, tiotropium, or umeclidinium;
  • cold or allergy medicine that contains an antihistamine;
  • medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
  • medicine for overactive bladder or urination problems;
  • medication for Parkinson's disease;
  • a beta-blocker --atenolol, metoprolol, propranolol, and others; or
  • an MAO inhibitor --isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

This list is not complete. Other drugs may interact with glycopyrrolate and indacaterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about glycopyrrolate and indacaterol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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