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glycopyrrolate and indacaterol (inhalation)

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, indacaterol, milk proteins, or if you have asthma.

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

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

What is glycopyrrolate and indacaterol?

Glycopyrrolate and indacaterol is a combination medicine used long term to treat people with COPD (chronic obstructive pulmonary disease).

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 glycopyrrolate and indacaterol if you are allergic to it, or if you have:

  • allergy to milk proteins; or
  • asthma.

Tell your doctor if you have ever had:

  • heart disease, high blood pressure;
  • a seizure;
  • liver or renal disease;
  • glaucoma;
  • diabetes;
  • a thyroid disorder;
  • bladder obstruction or other urination problems; or
  • any food or drug allergies.

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

You should not breastfeed while using glycopyrrolate and indacaterol.

This medicine 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 and read all medication guides. Use the medicine exactly as directed.

Glycopyrrolate and indacaterol is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

Utibron Neohaler is a powder that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load one capsule into the inhaler device each time you use the medicine. Pushing the buttons on the side of the Neohaler device will pierce the capsule and release the medicine into the inhaler chamber.

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

Use only the inhaler device provided with your medicine or you may not get the correct dose. Use the new inhaler each time you get your prescription refilled.

You should not stop using glycopyrrolate and indacaterol suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two capsules at one time. 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 chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache, and nervousness.

What should I avoid while using glycopyrrolate and indacaterol?

Do not use a second inhaled bronchodilator that contains indacaterol or a similar medicine (such as arformoterol, formoterol, olodaterol, salmeterol, or vilanterol).

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:

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

Common side effects may include:

  • back pain;
  • runny nose, sore throat; or
  • high blood pressure.

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?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect glycopyrrolate and indacaterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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