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budesonide and formoterol

Pronunciation

Generic Name: budesonide and formoterol (inhalation) (bue DES oh nide and for MOE te rol)
Brand Name: Symbicort, Symbicort Turbuhaler, Symbicort 400/12 Turbohaler

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).

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. Your doctor may tell you to stop using budesonide and formoterol once your asthma is well-controlled.

Budesonide and formoterol may also be used for purposes not listed in this medication guide.

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

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.

Slideshow: Flashback: FDA Drug Approvals 2013

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 budesonide and formoterol to treat an asthma attack that has already begun.

What should I discuss with my healthcare provider before using budesonide and formoterol?

You should not use this medicine if you are allergic to budesonide (Entocort, Pulmicort, Rhinocort) or formoterol (Foradil, Perforomist).

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.

FDA pregnancy category C. It is not known whether budesonide and formoterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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 12 years old.

How should I use budesonide and formoterol?

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 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.

If this medication gets in your eyes, rinse with water and call your doctor if you have severe eye redness or irritation.

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 try to take apart the inhaler device. Clean the mouthpiece every 7 days following the instructions in the medication guide.

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.

Budesonide and formoterol will not work fast enough to treat an asthma attack. Use only a fast acting inhalation medicine for an asthma attack.

Call your doctor if your symptoms do not improve after the first week of treatment, or if your symptoms get worse.

Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

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.

Wear a medical alert tag or carry an ID card to let others know that you may need an oral steroid in an emergency.

Your doctor will need to check your progress while you are using budesonide and formoterol. Your vision and bone mineral density may also need to be checked.

Store 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.

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. Do not float the canister in water or take it apart. 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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause severe headache, buzzing in your ears, confusion, chest pain, shortness of breath, fast or uneven heartbeats, tremor, or nervousness.

What should I avoid while using budesonide and formoterol?

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, Performist) or use a similar inhaled bronchodilator such as salmeterol (Serevent, Advair) or arformoterol (Brovana) unless your doctor has told you to.

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.

Budesonide and formoterol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening asthma symptoms;

  • wheezing, choking, or other breathing problems after using this medication;

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;

  • signs of infection--fever, chills, body aches, nausea, vomiting, unusual tiredness;

  • symptoms of pneumonia--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;

  • cold symptoms such as runny nose, sneezing, sore throat;

  • stomach discomfort;

  • back pain; or

  • mild 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.

See also: Side effects (in more detail)

Budesonide and formoterol dosing information

Usual Adult Dose for Asthma -- Maintenance:

Manufacturer recommendations: 2 oral inhalations twice a day (morning and evening, about 12 hours apart)

The recommended starting dosages are based upon patients' asthma severity.

The maximum recommended dosage is budesonide 160 mcg-formoterol 4.5 mcg twice a day.

Improvement in asthma control following inhaled administration of budesonide-formoterol can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1 to 2 weeks of therapy with Symbicort(R) 80/4.5 (budesonide 80 mcg-formoterol 4.5 mcg), replacement with Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg) may provide additional asthma control.

If a previously effective dosage regimen of budesonide-formoterol fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the lower strength of budesonide-formoterol with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

National Heart, Lung, and Blood Institute (NHLBI) recommendations: 2 oral inhalations twice a day; dose depends on severity of asthma

Budesonide 80 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on low- to medium-dose inhaled corticosteroid therapy.

Budesonide 160 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on medium- to high-dose inhaled corticosteroid therapy.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

For maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema:
Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg): 2 oral inhalations twice a day

Usual Pediatric Dose for Asthma -- Maintenance:

12 years or older:
Manufacturer recommendations: 2 oral inhalations twice a day (morning and evening, about 12 hours apart)

The recommended starting dosages are based upon patients' asthma severity.

The maximum recommended dosage is budesonide 160 mcg-formoterol 4.5 mcg twice a day.

Improvement in asthma control following inhaled administration of budesonide-formoterol can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1 to 2 weeks of therapy with Symbicort(R) 80/4.5 (budesonide 80 mcg-formoterol 4.5 mcg), replacement with Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg) may provide additional asthma control.

If a previously effective dosage regimen of budesonide-formoterol fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the lower strength of budesonide-formoterol with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

NHLBI recommendations: 2 oral inhalations twice a day; dose depends on severity of asthma

Budesonide 80 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on low- to medium-dose inhaled corticosteroid therapy.

Budesonide 160 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on medium- to high-dose inhaled corticosteroid therapy.

(Not approved by FDA)

5 to 11 years:
NHLBI recommendations:
Budesonide 80 mcg-formoterol 4.5 mcg: 2 oral inhalations twice a day

What other drugs will affect budesonide and formoterol?

Other drugs may interact with budesonide and formoterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about budesonide and formoterol.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.01. Revision Date: 2013-10-01, 8:40:24 AM.

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