What is the most important information I should know about formoterol and glycopyrrolate?
Formoterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Formoterol and glycopyrrolate is not for use in treating asthma.
What is formoterol and glycopyrrolate?
Formoterol is a bronchodilator. Glycopyrrolate is an anticholinergic. These medications work by relaxing muscles in the airways to improve breathing.
Formoterol and glycopyrrolate is a combination medicine used to prevent airflow obstruction or bronchospasm in people with COPD (chronic obstructive pulmonary disease).
This medicine is not for use in treating asthma.
Formoterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risk.
Formoterol and glycopyrrolate may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using formoterol and glycopyrrolate?
You should not use this medicine if you are allergic to formoterol or glycopyrrolate. Formoterol and glycopyrrolate is for use only in people with COPD and should not be used to treat asthma.
To make sure formoterol and glycopyrrolate is safe for you, tell your doctor if you have:
- heart disease;
- high blood pressure;
- liver disease;
- diabetes;
- epilepsy or other seizure disorder;
- glaucoma;
- a thyroid disorder;
- bladder obstruction or other urination problems;
- an enlarged prostate; or
- any food or drug allergies.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using formoterol and glycopyrrolate.
It is not known whether formoterol and glycopyrrolate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Formoterol and glycopyrrolate is not approved for use by anyone younger than 18 years old.
How should I use formoterol and glycopyrrolate?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Formoterol and glycopyrrolate is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack. Use only a fast acting inhalation medicine for an attack.
The usual dose of formoterol and glycopyrrolate is 2 inhalations 2 times per day, once in the morning and once in the evening. Follow your doctor's instructions.
Shake the medicine well just before you inhale your dose.
This medication comes with patient instructions for safe and effective use, and directions for priming and cleaning the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Clean the mouthpiece of your inhaler device at least 1 time every week to keep it from getting clogged. Remove the medicine canister before cleaning the device. Ask your pharmacist if you have questions about cleaning the device.
Use formoterol and glycopyrrolate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Seek medical attention if you think your COPD medications are not working as well, or if you feel like you need to use them more often.
You should not stop using formoterol and glycopyrrolate suddenly. Stopping suddenly may make your condition worse.
Store at room temperature away from moisture and heat. Always keep the cover on the inhaler device when not in use.
Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.
Throw the inhaler device away 3 months after you have taken it out of the sealed pouch, or when the dose indicator on the canister shows a "0" (zero puffs left), whichever comes first. Each canister contains 120 puffs.
Do not float the medicine canister in water to see if there is medicine left in it. Get your prescription refilled before the dose indicator reaches 0. Always use the new inhaler device provided with your refill.
What happens if I miss a dose?
Skip the missed dose and use the medicine when it is time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using formoterol and glycopyrrolate?
If this medicine gets in your eyes, rinse them with water and call your doctor if you have ongoing eye redness even after rinsing.
Do not use a second form of formoterol (such as Foradil, Dulera, Perforomist, Symbicort) or use a similar other long-acting inhaled bronchodilator such as salmeterol (Advair, Serevent) or arformoterol (Brovana) unless your doctor has told you to.
What are the possible side effects of formoterol and glycopyrrolate?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- wheezing, choking, or other breathing problems after using this medicine;
- new or worsening shortness of breath;
- chest pain;
- fast or irregular heartbeats;
- painful or difficult urination;
- pain or burning when you urinate;
- tremors or feeling nervous;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
-
high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
-
low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
Common side effects may include:
- cough; or
- urination problems.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect formoterol and glycopyrrolate?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- other bronchodilators such as aclidinium, arformoterol, indacaterol, ipratropium, olodaterol, salmeterol, tiotropium, umeclidinium, vilanterol;
- bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
- cold or allergy medicine that contains an antihistamine;
- medication for Parkinson's disease; or
- medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.
This list is not complete. Other drugs may interact with formoterol and glycopyrrolate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about formoterol and glycopyrrolate.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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