Budesonide and Formoterol

Budesonide and Formoterol is part of the drug class:

• Inhaled adrenergic and other drugs for obstructive airway diseases

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antifungal medications such as
  • ketoconazole (Nizoral) 
  • fluconazole (Diflucan) 
  • itraconazole (Sporanox) 
  • posaconazole (Noxafil)
• anti-HIV medications such as
  • efavirenz/emtricitabine/tenofovir (Atripla)
  • rilpivirine (Edurant)
  • emtricitabine (Emtriva)
  • elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild)
  • tenofovir/emtricitabine (Truvada)
  • tenofovir (Viread)
  • adefovir (Hepsera)

This is not a complete list of budesonide/formoterol drug interactions. Ask your doctor or pharmacist for more information.

• It is used to treat COPD (chronic obstructive pulmonary disease).
• It is used to treat asthma.
• This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

Use budesonide and formoterol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For breathing in only.
• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
• Prepare puffer (inhaler) before first use, when puffer has not been used for more than 7 days, or if it has been dropped. Spray 2 test sprays into the air. Shake well before each test spray.
• Shake well before use.
• Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
• Put the cap back on after you are done using your dose.
• This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when you have been told after opening or when the dose counter has a 0 in it, whichever comes first.
• Never wash the puffer (inhaler). Keep it dry.
• If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
• If you get budesonide and formoterol in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time budesonide and formoterol is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take budesonide and formoterol or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to budesonide and formoterol. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• Budesonide and Eformoterol
• Eformoterol and Budesonide
• Formoterol and Budesonide
• Formoterol Fumarate Dihydrate and Budesonide

Asthma: Inhalation:

Note: If asthma symptoms occur in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Children 6 to 11 years: Budesonide 80 mcg/formoterol 4.5 mcg: Metered dose inhaler: 2 inhalations twice daily (maximum: 2 inhalations twice daily). Note: The guidelines recommend use in children 5 to 11 years (NAEPP 2007).

Children ≥12 years and Adolescents: Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution and monitor closely; may lead to accumulation of budesonide and formoterol.

Long-acting beta-2 adrenergic agonists (LABAs) such as formoterol, one of the active ingredients in budesonide/formoterol, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABAs, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, only use budesonide/formoterol for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or for patients whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue budesonide/formoterol) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication such as an inhaled corticosteroid. Do not use budesonide/formoterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience pharyngitis, throat pain, back pain, abdominal pain, or rhinitis. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), angina, tachycardia, anxiety, mouth sores, bone pain, dizziness, passing out, seizures, severe headache, tremors, severe nausea, vomiting, severe loss of strength and energy, insomnia, burning or numbness feeling, flu-like signs, sinusitis, vision changes, eye pain, severe eye irritation, thrush, or signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.