What is the most important information I should know about budesonide and formoterol?
Budesonide and formoterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.
Seek medical attention you have worsening breathing problems, or if you think your medications are not working as well.
What is budesonide and formoterol inhalation?
Budesonide is a steroid that reduces inflammation in the body. Formoterol is a bronchodilator that relaxes muscles in the airways to improve breathing.
Budesonide and formoterol inhalation is a combination medicine used to prevent bronchospasm in people with asthma or chronic obstructive pulmonary disease (COPD). This medicine is for adults and children who are at least 6 years old.
For people with asthma: Budesonide and formoterol is for use only if asthma is severe or is not well-controlled on other long-term asthma medicines. Your doctor may tell you to stop using this medicine once your asthma is well-controlled.
Formoterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when budesonide and formoterol are used together as a combination product.
Budesonide and formoterol may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using budesonide and formoterol?
You should not use this medicine if you are allergic to budesonide (Entocort, Pulmicort, Rhinocort, Uceris) or formoterol (Foradil, Dulera, Perforomist).
Budesonide can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.
To make sure budesonide and formoterol is safe for you, tell your doctor if you have ever had:
- heart disease or high blood pressure;
- epilepsy or other seizure disorder;
- diabetes;
- glaucoma, cataracts, or herpes infection of the eyes;
- tuberculosis;
- any type of infection (bacterial, fungal, viral, or parasitic);
- liver disease;
- osteoporosis;
- an electrolyte imbalance (such as low potassium levels in your blood); or
- a thyroid disorder.
Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Budesonide and formoterol can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Do not give this medication to a child younger than 6 years old.
How should I use budesonide and formoterol?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using too much of this medicine can cause life-threatening side effects. Tell your doctor if you think your medications are not working as well.
This medicine comes with a medication guide 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.
Budesonide and formoterol is not a rescue medicine. It will not work fast enough to treat an asthma attack or COPD flare-up. Your doctor may prescribe a fast-acting inhalation medicine to treat a bronchospasm attack.
Always rinse out your mouth with water after using the inhaler device, to help prevent thrush (a fungal infection in the mouth or throat).
Do not allow a young child to use this medicine without help from an adult.
While using this medicine, your doctor may need to check your vision and bone mineral density.
Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.
If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.
Store this medicine at room temperature, away from moisture, light, 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.
Do not try to take apart the inhaler device. Clean the mouthpiece every 7 days following the instructions in the medication guide.
Throw the inhaler away when the inhalations counter on the canister shows a 0, or if it has been longer than 3 months since you first took the canister out of its foil pouch. The dose indicator on the inhaler will turn yellow when there are 20 doses left in the device. Get your prescription refilled before you run out of medicine completely. Always use the new inhaler device provided with your refill.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost 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. Overdose can cause severe headache, pounding in your neck or ears, confusion, chest pain, shortness of breath, pounding heartbeats or fluttering in your chest, tremor, or nervousness.
Using too much of a steroid long-term can lead to symptoms such as: thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.
What should I avoid while using budesonide and formoterol?
If this medication gets in your eyes, rinse with water and call your doctor if you have severe eye redness or irritation.
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as budesonide.
Do not use a second form of formoterol (Bevespi, Dulera) or other long-acting inhaled bronchodilator unless your doctor tells you to. This includes arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi, Stiolto Respimat), salmeterol (Advair, Serevent), or vilanterol (Breo Ellipta, Anoro Ellipta).
What are the possible side effects of budesonide and formoterol?
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:
- worsening breathing problems;
- wheezing, choking, or other breathing problems after using this medication;
- white patches in your mouth or throat, trouble swallowing;
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
-
signs of infection --fever, chills, body aches, nausea, vomiting, unusual tiredness;
-
symptoms of pneumonia --fever, cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
-
swelling of your blood vessels --numbness or tingling in your arms or legs, flu symptoms, stuffy nose, sinus pain, skin rash;
-
low potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
-
high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision.
Budesonide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.
Common side effects may include:
- throat irritation after using the inhaler;
- stomach discomfort, vomiting;
- cold symptoms such as stuffy or runny nose, sneezing, sinus pain, sore throat;
- flu symptoms (fever, chills, body aches); or
- back pain, headache.
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 budesonide and formoterol?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- antifungal medicine; or
- HIV or AIDS medication.
This list is not complete. Other drugs may interact with budesonide and formoterol, 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 budesonide and formoterol.
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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 8.01. Revision date: 12/26/2017.
