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Glycopyrrolate and formoterol (Inhalation route)

Pronunciation:

glye-koe-PIR-oh-late, for-MOE-ter-ol FUE-ma-rate

Brand Names:

  • Bevespi Aerosphere

Dosage Forms:

  • Aerosol Powder

Warnings:

Inhalation route(Aerosol Powder)

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

Classifications:

Therapeutic

Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic

Antimuscarinic

Uses of This Medicine:

Glycopyrrolate and formoterol combination is used for the long-term maintenance 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. Formoterol 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

Inhaled glycopyrrolate and formoterol combination is not indicated for use in 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 glycopyrrolate and formoterol 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.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Potassium
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

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.

  • Amiodarone
  • Anagrelide
  • Aripiprazole
  • Bupropion
  • Buserelin
  • Dabrafenib
  • Degarelix
  • Delamanid
  • Deslorelin
  • Domperidone
  • Donepezil
  • Escitalopram
  • Fluoxetine
  • Gonadorelin
  • Goserelin
  • Histrelin
  • Hydroxychloroquine
  • Ivabradine
  • Leuprolide
  • Levofloxacin
  • Metronidazole
  • Nafarelin
  • Oxymorphone
  • Panobinostat
  • Pasireotide
  • Pimavanserin
  • Pitolisant
  • Quetiapine
  • Sulpiride
  • Tacrolimus
  • Tiotropium
  • Triptorelin
  • Vemurafenib
  • Vinflunine
  • Zuclopenthixol

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:

  • 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.
  • Kidney disease, severe or
  • Liver disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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.

When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine 4 times into the air away from the face, and shaking it well before each spray. If you have not used it for 7 days or longer, re-prime it by spraying the medicine 2 times into the air away from the face, and shaking it well before each spray.

To use the inhaler:

  • This medicine comes in sealed foil pouch. Do not open the sealed foil pouch until you are ready to use a dose of this medicine.
  • Once opened, remove the inhaler from the pouch.
  • Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear.
  • Press the center of the dose indicator all the way down and release it. You may hear a soft click from the dose indicator as it counts down during use.
  • To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until you hear a "click" sound. Keep breathing in, even after you hear the "click" sound to be sure you get the full dose.
  • Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose.
  • Clean the inhaler 1 time each week by taking the canister out of the actuator and allow warm water to run through it for about 30 seconds. Turn the actuator upside down and rinse again for about 30 seconds. Let the actuator air-dry overnight.

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 (aerosol):
    • For COPD:
      • Adults Two puffs in the morning and another 2 puffs in the evening. Each puff contains 9 micrograms (mcg) of glycopyrrolate and 4.8 mcg of formoterol.
      • 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.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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
Bladder pain
bloody or cloudy urine
chest pain
cough
difficult, burning, or painful urination
frequent urge to urinate
lower back or side pain
Incidence not known
Blindness
blurred vision
decrease in the frequency of urination
decrease in urine volume
decreased vision
difficulty with breathing
dizziness
eye pain
fainting
headache
hives or welts, itching, or skin rash
irregular heartbeat
nausea or vomiting
nervousness
noisy breathing
pounding in the ears
recurrent large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
redness of the skin
slow or fast heartbeat
tearing
tightness in the chest

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
Difficulty with moving
dry mouth
fear
fever
muscle pain or stiffness
muscle spasm
pain in the arms or legs
pain in the joints
pain or tenderness around the eyes and cheekbones
sore throat
stuffy or runny nose
unusual tiredness or weakness

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: 9/15/2016
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