What is the most important information I should know about budesonide and formoterol?

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.

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.

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?

To make sure budesonide and formoterol is safe for you, tell your doctor if you have:

• heart disease or high blood pressure;
• epilepsy or other seizure disorder;
• diabetes;
• glaucoma, cataracts, or herpes infection of the eyes;
• any active infection, including tuberculosis;
• liver disease;
• weak immune system (caused by disease or by using certain medicine);
• 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.

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.

How should I use budesonide and formoterol?

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.

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.

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.

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?

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?

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.

What are the possible side effects of budesonide and formoterol?

• worsening asthma symptoms;
• wheezing, choking, or other breathing problems after using this medication;
• 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, wheezing, 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 --confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
• high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

• white patches in your mouth or throat (call your doctor if this occurs);
• 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 medicines you use, and those you start or stop using during your treatment with budesonide and formoterol, especially:

• imatinib, isoniazid, nefazodone;
• an antibiotic --clarithromycin, erythromycin, telithromycin;
• antifungal medicine --itraconazole, ketoconazole, posaconazole, voriconazole;
• heart medication --carvedilol, labetalol, nicardipine, propranolol, quinidine, sotalol, timolol, and others;
• hepatitis C medications --boceprevir, telaprevir; or
• HIV/AIDS medication --atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

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.