Glycopyrrolate and indacaterol inhalation

Name: Glycopyrrolate and indacaterol inhalation

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 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.

Glycopyrrolate and indacaterol side effects

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.

Glycopyrrolate and indacaterol dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

UTIBRON NEOHALER (R):
-1 inhalation (glycopyrrolate 15.6 mcg-indacaterol 27.5 mcg) orally TWICE a day (in the morning and in the evening)

Comments:
-For each inhalation, administer the content of 1 capsule using the NEOHALER device.
-More frequent administration or a greater number of inhalations (more than 1 capsule twice a day) is not recommended. Do not use 2 capsules at one time.

ULTIBRO BREEZHALER (R):
-1 inhalation (glycopyrrolate 50 mcg-indacaterol 110 mcg) orally ONCE a day

Comment:
-Inhale orally the content of one capsule using the BREEZHALER inhaler.

Use: Long term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema

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.

Glycopyrrolate / indacaterol Breastfeeding Warnings

Indacaterol: Indacaterol and its metabolites have been detected in the milk of lactating rats. Glycopyrrolate: Glycopyrrolate and its metabolites have been detected in the milk of lactating rats and reached up to 10-fold higher concentrations in the milk than in the blood of the dam. Reduced body weight gain was observed in pups of rats treated with indacaterol or glycopyrrolate, while impaired learning and decreased fertility were observed in pups of rats treated with indacaterol during pregnancy and lactation.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown (glycopyrrolate-indacaterol) Excreted into animal milk: Yes (glycopyrrolate-indacaterol) Comments: The effects in the nursing infant are unknown.

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