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Budesonide/Formoterol is available as a metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol.

Budesonide/Formoterol is an inhaled corticosteroid/LABA combination that is used to treat:

• Asthma
• Chronic obstructive pulmonary disease (COPD)

Budesonide/Formoterol is a combination of two medications. Budesonide is a corticosteroid that works in your lungs to lower swelling and inflammation, making it easier for you to breathe. Formoterol is a long-acting beta-agonist (LABA) that relaxes the muscles around the airways to the lungs. This opens up the lungs and makes breathing easier.

Budesonide/Formoterol is dosed as follows:

Asthma

• Adults and children age 12 years and older: The typical dose is 2 inhalations of Budesonide/Formoterol 80/4.5 or Budesonide/Formoterol 160/4.5 twice daily
• Children ages 6-11 years old: The typical dose is 2 inhalations of Budesonide/Formoterol 80/4.5 by mouth twice a day

COPD

• Adults: The typical dose is 2 inhalations of Budesonide/Formoterol 160/4.5 by mouth twice a day

Budesonide/Formoterol is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures
• Hypersensitivity to any of the ingredients in Budesonide/Formoterol

Common side effects of Budesonide/Formoterol:

• Asthma
• Common cold (sore throat, headache, cough)
• Headache
• Upper respiratory tract infection (sneezing, throat pain)
• Sore throat
• Stuffy nose

COPD

• Common cold
• Thrush (yeast infection in your mouth or throat)
• Bronchitis (inflammation of the airways)

Serious side effects are rare with Budesonide/Formoterol. Contact your healthcare provider immediately if you experience any of the following.

• Severe allergic reaction: swelling, rash, trouble breathing
• Overdose: chest pain, fast heart rate, dizziness, headache, tremor, muscle cramps, nausea, tiredness, trouble sleeping
• Sudden breathing problems: sudden shortness of breath, difficulty breathing, coughing, wheezing

The following medications may interact with Budesonide/Formoterol:

• Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of formoterol on vascular system.
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm
• Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists

Various FDA-approved generic manufacturers

It is not known if Budesonide/Formoterol can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Budesonide/Formoterol. You and your healthcare provider will decide if you should take Budesonide/Formoterol while you are pregnant.

• Symbicort