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Indacaterol and glycopyrrolate (Inhalation route)

Pronunciation:

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

Brand Names:

  • Utibron Neohaler

Dosage Forms:

  • Capsule

Warnings:

Inhalation route(Capsule)

Indacaterol and glycopyrrolate oral inhalation powder is not indicated for the treatment of asthma. Long-acting beta(2)-adrenergic agonists (LABAs), such as indacaterol, increase the risk of asthma-related death .

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Beta-2 Adrenergic Agonist

Uses of This Medicine:

Indacaterol and glycopyrrolate combination is used for the long-term treatment of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema. The medicines help open the air passages in the lung to increase air flow and are called bronchodilators. Indacaterol and glycopyrrolate combination is an inhaler that is breathed in through the mouth.

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 recommended for children. 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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

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.

  • Bupropion
  • Carteolol
  • Carvedilol
  • Donepezil
  • Labetalol
  • Levobunolol
  • Metipranolol
  • Nadolol
  • Oxprenolol
  • Penbutolol
  • Pindolol
  • Practolol
  • Propranolol
  • Sotalol
  • Timolol
  • Tiotropium

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
  • Hyperthyroidism (overactive thyroid) or
  • Hypokalemia (low potassium in the blood) or
  • Seizures, history of or
  • Trouble urinating—Use with caution. May make these conditions worse.

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 Medication Guide or 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, have your doctor show you what to do.

You will use this medicine with a special inhaler device called the Utibron™ Neohaler®. The medicine is in a capsule that is placed in 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 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.
  • Remove the inhaler from your mouth. Hold your breath for as long as you can and then exhale.
  • Open the inhaler and remove the empty capsule. Discard the used capsule.
  • Close the mouthpiece and replace the cover.
  • Do not wash the inhaler. Keep it dry.

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 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:

If you will be using this medicine for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used if you are having a sudden COPD attack. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, 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, budesonide/formoterol, formoterol, salmeterol, or vilanterol.

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.

If you develop a skin rash, hives, swelling of the tongue, lips, or face, or any allergic reaction to this medicine, check with your doctor right away.

This medicine might cause an increase in heart rate or blood pressure. Contact your doctor if you have a fast or slow heartbeat or if your blood pressure is higher than normal.

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 you to have your eyes 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.

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
dizziness
headache
nervousness
pounding in the ears
slow or fast heartbeat
Incidence not known
Abdominal or stomach pain
blindness
convulsions
decrease in the frequency of urination
decrease in urine volume
decreased vision
difficulty in passing urine (dribbling)
dry mouth
eye pain
fainting
flushed, dry skin
fruit-like breath odor
hives or welts, itching, or skin rash
increased hunger
increased thirst
increased urination
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
mood changes
muscle pain or cramps
nausea or vomiting
nosebleeds
numbness or tingling in the hands, feet, or lips
painful urination
redness of the skin
sweating
tearing
troubled breathing
unexplained weight loss
unusual tiredness or weakness
vision problems

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
Fever
back pain
muscle aches
sore throat
stuffy or runny nose

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.


Last Updated: 8/4/2017
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