Formoterol may increase the risk of asthma-related death or breathing problems that require you to be in the hospital. Use only the prescribed dose of budesonide and formoterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.
For people with asthma: This medicine is for use only if asthma is severe or is not well-controlled on other long-term asthma medication, such as an inhaled steroid.
Do not use this medicine to treat an asthma attack that has already begun.
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.
Budesonide and formoterol may also be used for purposes not listed in this medication guide.
You should not use this medicine if you are allergic to budesonide (Entocort, Pulmicort, Rhinocort, Uceris) or formoterol (Foradil, Dulera, Perforomist).
To make sure budesonide and formoterol is safe for you, tell your doctor if you have:
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.
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.
Do not give this medication to a child younger than 6 years old.
Formoterol may increase the risk of asthma-related death or breathing problems that require you to be in the hospital. Use only the prescribed dose of this medicine, and do not use it for longer than your doctor recommends. Follow all directions on your prescription label and the patient instructions for safe use.
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.
Call your doctor if your symptoms do not improve after the first week of treatment, or if you think your asthma medications are not working as well. If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.
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.
If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.
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.
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.
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.
If this medication gets in your eyes, rinse with water and call your doctor if you have severe eye redness or irritation.
Do not use a second form of formoterol (such as Foradil, Dulera, Perforomist), or a similar long-acting bronchodilator such as salmeterol (Serevent, Advair) or arformoterol (Brovana).
Using a steroid can lower the blood cells that help your body fight infections. 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 steroid medicines.
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:
Common side effects may include:
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.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with budesonide and formoterol, especially:
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.
Your pharmacist can provide more information about budesonide and formoterol.