Glycopyrrolate and formoterol (Inhalation)

Glycopyrrolate and formoterol combination is used for long-term treatment of chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. COPD is a long-lasting lung disease that leads to bronchospasm (wheezing or difficulty breathing).

Glycopyrrolate and formoterol are long-acting bronchodilators. Bronchodilators are medicines that you inhale through your mouth to open the bronchial tubes (air passages) in your lungs. They help relieve cough, wheezing, shortness of breath, and difficulty breathing by increasing airflow through the bronchial tubes.

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

It is very important for your doctor to check your progress during regular visits to ensure the medicine is working correctly. Blood and urine tests may be required to look for any unwanted effects.

Let your doctor know if you are using any other medicine for your COPD. Your doctor may recommend using it only during a severe COPD attack. Follow your doctor's instructions on how to take your medicine.

This medicine should not be used if you have a sudden COPD attack, or if you already have symptoms of a COPD attack. Your doctor will provide you with a short-acting inhaler for this situation. If the short-acting inhaler is not effective, tell your doctor immediately.

Contact your doctor or seek medical care right away if:

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

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

This medicine may increase the risk of worsening asthma, which can lead to hospitalization, intubation, and death in asthma patients who take this medicine without an inhaled steroid. Discuss any concerns with your doctor.

This medicine may cause paradoxical bronchospasm, meaning your breathing or wheezing could worsen. This can be a life-threatening situation. Contact your doctor immediately if you experience a cough, trouble 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, contact your doctor immediately.

This medicine may cause heart or blood vessel issues, including heart rhythm problems. Contact 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, trouble breathing, or weight gain.

Call your doctor immediately if you experience blurred vision, difficulty reading, seeing halos around lights, or any other change in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

Hypokalemia (low potassium in the blood) may occur while using this medicine. Contact 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 your blood or urine sugar test results, contact your doctor.

Contact your doctor immediately if you experience a decrease in urine volume, decreased frequency of urination, difficulty passing urine, or painful urination.

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

In deciding to use a drug, the risks of using the drug 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

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Additionally inform 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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of inhaled glycopyrrolate and formoterol combination in the elderly.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different drugs 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 medication, it is especially essential that your healthcare professional know if you are taking any of the drugs 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 medications is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Potassium Citrate
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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

• Acebutolol
• Aclidinium
• Adagrasib
• Alfuzosin
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atenolol
• Atropine
• Azithromycin
• Bedaquiline
• Belladonna
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Benztropine
• Betaxolol
• Biperiden
• Bisoprolol
• Brompheniramine
• Bumetanide
• Buprenorphine
• Bupropion
• Buserelin
• Carbinoxamine
• Carisoprodol
• Carteolol
• Carvedilol
• Celiprolol
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clofazimine
• Clomipramine
• Clopamide
• Clothiapine
• Clozapine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclopentolate
• Cyclothiazide
• Cyproheptadine
• Dabrafenib
• Darifenacin
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Diazoxide
• Dibenzepin
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Esmolol
• Ethacrynic Acid
• Etozolin
• Etrasimod
• Famotidine
• Felbamate
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flavoxate
• Flecainide
• Fluconazole
• Fluoxetine
• Fluphenazine
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furosemide
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Homatropine
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Hyoscyamine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Inotuzumab Ozogamicin
• Ipratropium
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Labetalol
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levobunolol
• Levofloxacin
• Linezolid
• Lofepramine
• Lofexidine
• Loxapine
• Lumefantrine
• Macimorelin
• Meclizine
• Mefloquine
• Melitracen
• Mepenzolate
• Methacholine
• Methadone
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metipranolol
• Metolazone
• Metoprolol
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nadolol
• Nafarelin
• Nebivolol
• Nelfinavir
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Opipramol
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxitropium Bromide
• Oxprenolol
• Oxybutynin
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Penbutolol
• Pentamidine
• Perphenazine
• Phenelzine
• Phenobarbital
• Pimavanserin
• Pimozide
• Pindolol
• Pipamperone
• Pipenzolate Bromide
• Pirenzepine
• Piretanide
• Pitolisant
• Polythiazide
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propafenone
• Propantheline
• Propiverine
• Propranolol
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Revefenacin
• Ribociclib
• Risperidone
• Ritonavir
• Safinamide
• Scopolamine
• Secretin Human
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Stramonium
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Terodiline
• Tetrabenazine
• Thioridazine
• Thiothixene
• Tianeptine
• Timolol
• Tiotropium
• Tizanidine
• Tolterodine
• Toremifene
• Torsemide
• Tranylcypromine
• Trazodone
• Trichlormethiazide
• Triclabendazole
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Triptorelin
• Tropicamide
• Trospium
• Umeclidinium
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Xipamide
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 medications may additionally cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical issues may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, 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
• 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) or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the drug from the body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• Chills
• Cough
• Diarrhea
• Difficult, burning, or painful urination
• Fever
• Frequent urge to urinate
• General feeling of discomfort or illness
• Headache
• Joint pain
• Loss of appetite
• Lower back or side pain
• Muscle aches and pains
• Nausea
• Pain or tenderness around the eyes and cheekbones
• Shivering
• Sore throat
• Stuffy or runny nose
• Sweating
• Tightness of the chest
• Trouble sleeping
• Troubled breathing
• Unusual tiredness or weakness
• Vomiting

Incidence not known

• Agitation
• Blurred vision
• Decrease in the frequency of urination
• Difficulty in passing urine (dribbling)
• Dizziness
• Dry mouth
• Fainting
• Fast, pounding, or irregular heartbeat or pulse
• Flushed, dry skin
• Fruit-like breath odor
• Hives or welts, itching, or skin rash
• Hoarseness
• Increased hunger
• Increased thirst
• Irritation
• Joint stiffness or swelling
• Redness of the skin
• Restlessness
• Stomach pain
• Swelling of the eyelids, face, lips, hands, or feet
• Tremor
• Trouble swallowing
• Unexplained weight loss

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

Less common

• Anxiety
• Arm or leg pain
• Bruise
• Difficulty with moving
• Falls
• Mouth or throat pain
• Muscle spasm or stiffness
• Toothache

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.

In the U.S.

• Bevespi Aerosphere

Available Dosage Forms:

• Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Antimuscarinic

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 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. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

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.

Throw the medicine 3 months after you first use it (3 weeks for the 28 inhalation canister) or when the dose indicator reaches zero “0”.