Indacaterol and glycopyrrolate

Indacaterol and glycopyrrolate is a prescription medication used to treat Chronic Obstructive Pulmonary Disease (COPD).

It is a single product containing 2 products: indacaterol and glycopyrrolate. 

Indacaterol belongs to a group of drugs called long-acting beta2-adrenergic agonist (LABA). Glycopyrrolate belongs to a group of drugs called anticholinergics. Together these work to help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.

This medication is available in capsule form to use with a specially designed inhaler. The capsules are inserted into the neohaler and inhaled twice a day.

Do not swallow capsules. Instead, using the Neohaler, the capsule is punctured, and the powder inside the capsule is inhaled into the lungs. 

Common side effects include sore throat and runny nose, high blood pressure, and back pain.

Indacaterol/glycopyrrolate is a prescription medication used to treat Chronic Obstructive Pulmonary Disease (COPD).

• Indacaterol/glycopyrrolate is not used to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
• Indacaterol/glycopyrrolate is not approved to treat asthma. It is not known if this medication is safe and effective in people with asthma
• Indacaterol/glycopyrrolate should not be used in children. It is not known if this medication is safe and effective in children younger than 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Indacaterol and glycopyrrolate may be found in some form under the following brand names:

• Utibron Neohaler

Serious side effects have been reported with indacaterol/glycopyrrolate. See the “Drug Precautions” section.

Common side effects include the following:

• sore throat
• runny nose
• high blood pressure
• back pain

This is not a complete list of side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Anticholinergics such as umeclidinium, tiotropium, ipratropium, and aclidinium
• LABA medicines such as formoterol, salmeterol, vilanterol, indacaterol, and olodaterol)
• Beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• Monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), rasagiline (Azilect)
• Tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• Diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), triamterene (Dyrenium, Dyazide, Maxzide)
• Medications that can prolong the QTc interval such as:
  • certain antiarrhythmic medications such as procainamide, sotalol (Betapace), quinidine, dofetilide (Tikosyn), amiodarone (Nexterone, Pacerone, Cordarone), ibutilide (Corvert)
  • certain fluoroquinolone antibiotics such as levofloxacin (Levaquin), ciprofloxacin (Cipro), gatifloxacin (Zymar), moxifloxacin (Avelox)
  • certain macrolide antibiotics such as clarithromycin (Biaxin) and erythromycin (EES)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with this medication including the following:

• Sudden shortness of breath immediately after use of indacaterol/glycopyrrolate. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, stop taking Utibron Neohaler and call your healthcare provider or go to the nearest hospital emergency room right away.
• Serious allergic reactions. Stop using indacaterol/glycopyrrolate and call your healthcare provider or get emergency medical care right away if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of the tongue, lips, and face
  • difficulty breathing or swallowing
• Effects on your heart such as fast or irregular heartbeat (palpitations), increased blood pressure, and chest pain
• New or worsened eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:
  • eye pain or discomfort o nausea or vomiting
  • blurred vision
  • red eyes
  • seeing halos or bright colors around lights

If you have these symptoms, stop using indacaterol/glycopyrrolate and call your healthcare provider right away before taking another dose.

• New or worsened urinary retention. People who use indacaterol/glycopyrrolate may develop new or worse urinary retention. Urinary retention can be caused by a blockage in your bladder. Urinary retention can also happen in men who have a larger than normal prostate. Symptoms of urinary retention may include:
  • difficulty urinating
  • painful urination
  • urinating frequently
  • urination in a weak stream or drips

If you have these symptoms, stop using indacaterol/glycopyrrolate and call your healthcare provider right away before using another dose.

• Changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia) which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.
• Increased risk of death from asthma problems. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as indacaterol have an increased risk of death from asthma problems. It is not known if LABA medicines, such as indacaterol increase the risk of death in people with COPD. Call your healthcare provider if breathing problems worsen over time while using indacaterol/glycopyrrolate. You may need a different treatment. Get emergency medical care if:
• breathing problems worsen quickly
• you use your rescue inhaler medicine, but it does not relieve your breathing problems

Indacaterol/glycopyrrolate is not used to treat sudden symptoms of COPD. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms of COPD. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.

Indacaterol/glycopyrrolate is not for the treatment of asthma. It is not known if this medication is safe and effective in people with asthma.

Indacaterol/glycopyrrolate should not be used in children. It is not known if this medication is safe and effective in children younger than 18 years of age.

Do not take this medication if you:

• are allergic to this medication or to any of its ingredients
• have asthma and not using a long-term asthma controller medication. This medication is not indicated for the treatment of asthma. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of indacaterol/glycopyrrolate, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using indacaterol/glycopyrrolate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to indacaterol/glycopyrrolate or to any of its ingredients. This medication contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy.
• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have kidney problems
• have eye problems such as glaucoma. This medication may make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. Indacaterol/glycopyrrolate may make these problems worse.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if indacaterol/glycopyrrolate can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk and if it can harm your baby. You and your healthcare provider should decide if you will take indacaterol/glycopyrrolate or breastfeed.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Indacaterol/glycopyrrolate falls into category C. No well-controlled studies have been done in humans. It is not known if indacaterol/glycopyrrolate can harm your unborn baby. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. Contact your physician immediately if you become pregnant while using indacaterol/glycopyrrolate.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if indacaterol/glycopyrrolate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using indacaterol/glycopyrrolate.

Use indacaterol/glycopyrrolate exactly as prescribed. Do not use Utibron Neohaler more often than prescribed for you. Do not use more than 2 capsules in a day. 

This medication is available in capsule form to use with a specially designed inhaler. The capsules are inserted into the neohaler and inhaled twice a day.

Do not use indacaterol/glycopyrrolate unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.

Do not swallow capsules. 

Only use capsule with the Inhaler.

Use 1 capsule inhaled through the inhaler 2 times each day (1 capsule in the morning and 1 capsule in the evening).

To make sure that the full dose has been taken, you should open the inhaler to check that there is no powder left in the capsule. As long as the capsule is empty, you have received 1 full dose. 

• Peel the backing foil away from the blister to open it, do not push the capsule through the foil.
• Always use the new inhaler that is provided with each new prescription.

Indacaterol/glycopyrrolate does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have a rescue inhaler prescribed for you.

Do not stop using indacaterol/glycopyrrolate or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse.

Your healthcare provider will change your medicines as needed.

Call your healthcare provider or get emergency medical care right away if your breathing problems worsen with indacaterol/glycopyrrolate, you need to use your rescue medicine more often than usual, or your rescue inhaler medicine does not work as well for you at relieving your symptoms.

If you miss a dose of indacaterol/glycopyrrolate, take it as soon as you remember. Take your next dose at your usual time. Do not use 2 capsules at one time. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

If you take too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store (inhaler and blister-packaged capsules) at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not remove capsules from the blister card it comes in until you are ready to use a dose of of this medication. 
• Do not store capsules in the inhaler.
• Keep this medication in a dry place away from light and moisture.
• Keep this medicationand all medicines out of the reach of children.