Pronunciation:

in-da-KAT-er-ol, glye-koe-PIR-oh-late

Brand Names:

• Utibron Neohaler

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Beta-2 Adrenergic Agonist

Uses of This Medicine:

Indacaterol and glycopyrrolate combination is used as long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

Indacaterol and glycopyrrolate are a long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Indacaterol and glycopyrrolate combination is not for use in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled indacaterol and glycopyrrolate combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Aclidinium
• Amantadine
• Amifampridine
• Amitriptyline
• Amoxapine
• Arotinolol
• Atenolol
• Atropine
• Befunolol
• Belladonna
• Benztropine
• Betaxolol
• Bevantolol
• Biperiden
• Bisoprolol
• Bopindolol
• Brompheniramine
• Bucindolol
• Bupranolol
• Buprenorphine
• Bupropion
• Carbinoxamine
• Carisoprodol
• Carteolol
• Carvedilol
• Celiprolol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dilevalol
• Dimenhydrinate
• Diphenhydramine
• Donepezil
• Doxepin
• Esmolol
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glucagon
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Labetalol
• Landiolol
• Levobunolol
• Loxapine
• Meclizine
• Mepenzolate
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxprenolol
• Oxybutynin
• Oxycodone
• Paroxetine
• Penbutolol
• Perphenazine
• Pimozide
• Pindolol
• Pipenzolate Bromide
• Pirenzepine
• Practolol
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Propranolol
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Solifenacin
• Sotalol
• Stramonium
• Talinolol
• Tapentadol
• Terodiline
• Tertatolol
• Thioridazine
• Thiothixene
• Timolol
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to milk proteins—Use with caution. This medicine contains lactose (milk sugar) and milk proteins.

• Bladder problems or
• Diabetes or
• Enlarged prostate or
• Glaucoma, narrow angle or
• Heart or blood vessel disease or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Hypokalemia (low potassium in the blood) or
• Seizures, history of or
• Thyroid problems (eg, thyrotoxicosis) or
• Trouble urinating—Use with caution. May make these conditions worse.

• Kidney disease, severe (eg, end-stage kidney disease, patients requiring dialysis)—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Liver disease, severe—Use has not been studied in patients with this condition.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop using this medicine without telling your doctor. To do so may make your condition worse.

This medicine comes with a patient information leaflet and patient instructions. Read the instructions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

You will use this medicine with a special inhaler device called the Utibron™ Neohaler®. The medicine is in a capsule that is placed inside the inhaler device. Do not swallow the capsule. The inhaler device loads the medicine from the capsule into the air chamber. You will inhale the powder through the mouthpiece.

Use this medicine at the same time each day to help prevent COPD attacks.

To use the inhaler:

• Dry your hands before handling this medicine.
• Open a blister card of capsules. Do not remove a capsule until you are ready for a dose. Do not push the capsule through the foil to remove it from the blister.
• Open the base of the inhaler and tilt the mouthpiece to open the inhaler.
• Place the capsule in the chamber at the base of the inhaler. Do not swallow the capsule and do not place it directly into the mouthpiece.
• Close the inhaler. You should hear a clicking sound as you close it.
• Hold the mouthpiece upright. Press both buttons at the same time and only once. You should hear a click as the capsule is being pierced.
• Breathe out fully. Do not exhale into the mouthpiece.
• Place the mouthpiece in your mouth and breathe in quickly and deeply. 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.
• Remove the inhaler from your mouth. Hold your breath for at least 5 to 10 seconds or for as long as you can and then exhale.
• Open the inhaler and remove the empty capsule. Throw away the used capsule.
• Close the mouthpiece and replace the cover.
• Do not wash the inhaler. Keep it dry. You may wipe the device with a clean, dry, lint-free cloth or a clean, dry, soft brush.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inhalation dosage form:
  • For maintenance treatment of COPD:
    • Adults—1 capsule by oral inhalation 2 times a day, in the morning and evening.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Do not use more than 2 capsules in 24 hours.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Talk to your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine for a few days or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana™), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), salmeterol/fluticasone (Advair®), or vilanterol.

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. This may be a life-threatening situation. Check with your doctor right away if you have a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.

This medicine may cause serious allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: decreased urine, dry mouth, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, uneven heartbeat, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

body aches or pain

chest pain

chills

cough

difficulty in breathing

dizziness

dry mouth

ear congestion

fever

flushed, dry skin

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

loss of voice

nausea

nervousness

pounding in the ears

runny or stuffy nose

slow or fast heartbeat

sneezing

sore throat

stomach pain

sweating

tightness in the chest

unexplained weight loss

unusual tiredness or weakness

vomiting

Rare

Bloating or swelling of the face, arms, hands, lower legs, or feet

decreased urination

fainting

fast, pounding, or irregular heartbeat or pulse

pain in the lower abdomen, groin, upper back, or sides

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Back pain

diarrhea

fever

heartburn

mouth or throat pain

muscle aches

Rare

Belching

indigestion

loss of appetite

stomach discomfort or upset

trouble sleeping

Less common

Hoarseness

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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