budesonide and formoterol (inhalation)

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

What is budesonide and formoterol inhalation?

Formoterol is a long-acting bronchodilator. Budesonide is a steroid.

Budesonide and formoterol is a combination medicine used to control and prevent the symptoms of asthma in adults and children at least 6 years old.

Budesonide and formoterol is also used to help control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

This medicine is not for use in treating an asthma or bronchospasm attack.

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?

Budesonide can weaken your immune system. Tell your doctor about any illness or infection you've had within the past several weeks.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• a weak immune system;
• liver disease;
• osteoporosis;
• glaucoma, cataracts, or other vision problems;
• diabetes;
• a drug allergy;
• tuberculosis;
• a thyroid disorder; or
• an electrolyte imbalance (such as low potassium levels in your blood).

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

How should I use budesonide and formoterol?

Follow all directions on your prescription label and read all medication guides. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not allow a young child to use budesonide and formoterol without help from an adult.

Rinse your mouth with water after each use of your inhaler.

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 use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Throw the canister away when the inhalations counter shows a 0, or if it has been longer than 3 months since you first took the canister out of its foil pouch.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include chest pain, fast heartbeats, and feeling shaky or nervous.

What should I avoid while using budesonide and formoterol?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a steroid such as budesonide.

What are the possible side effects of budesonide and formoterol?

• worsened breathing problems;
• sores or white patches in your mouth and throat, pain when swallowing;
• tremors, nervousness, chest pain, fast or pounding heartbeats;
• cough with mucus, feeling short of breath;
• wheezing, choking, or other breathing problems after using this medication;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• flu symptoms --fever, chills, body aches, unusual tiredness;
• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder --tiredness or weakness, feeling light-headed, nausea, vomiting.

Budesonide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• throat pain or irritation;
• white patches in your mouth or throat;
• stomach discomfort, vomiting;
• back pain, headache;
• flu symptoms; or
• cold symptoms such as stuffy or runny nose, sneezing, sinus pain, sore throat.

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?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect budesonide and formoterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about budesonide and formoterol.