Description
Glycopyrrolate and formoterol combination is used as long-term maintenance treatment of 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).
Glycopyrrolate and formoterol are 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.
This product is available in the following dosage forms:
- Aerosol Powder
Before Using
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.
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 problems that would limit the usefulness of inhaled glycopyrrolate and formoterol combination in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Bepridil
- Cisapride
- Dronedarone
- Isocarboxazid
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Potassium Citrate
- 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.
- Acebutolol
- Aclidinium
- Adagrasib
- Alfuzosin
- Amantadine
- Amifampridine
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atenolol
- Atropine
- Azithromycin
- Bedaquiline
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benzhydrocodone
- Benzthiazide
- Benztropine
- Betaxolol
- Biperiden
- Bisoprolol
- Brompheniramine
- Bumetanide
- Buprenorphine
- Bupropion
- Buserelin
- Carbinoxamine
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
- 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 because of slower removal of the medicine from the body.
Proper Use
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.
- For COPD:
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”.
Precautions
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 sudden COPD attack, or if symptoms of COPD attack has already started. 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 (Brovana®), budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), 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.
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 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 you to have your eyes checked by an ophthalmologist (eye doctor).
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.
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
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
- 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. 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
- 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.
CON-XXXXXXXX
