How does this medication work? What will it do for me?

This combination product contains two medications: budesonide and formoterol. Budesonide belongs to the group of medications known as corticosteroids. It works by reducing the swelling in the airways of the lungs. Formoterol belongs to the group of medications known as bronchodilators. It works by relaxing the muscles surrounding the airways and allowing the airways to open.

This medication is used to treat reversible obstructive airways disease, often known as asthma. When combined, these medications help to control the symptoms of asthma and prevent asthma attacks by keeping the airways open to make breathing easier.

It is also used for maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Symbicort 100 Turbuhaler
Each dry powder inhaler contains: budesonide 100 µg and formoterol fumarate dihydrate 6 µg per dose. Also contains lactose which acts as a "carrier." The amount added does not normally cause problems in lactose-intolerant people.

Symbicort 200 Turbuhaler
Each dry powder inhaler contains: budesonide 200 µg and formoterol fumarate dihydrate 6 µg per dose. Also contains lactose which acts as a "carrier." The amount added does not normally cause problems in lactose-intolerant people.

How should I use this medication?

For asthma treatment, budesonide - formoterol can be used for maintenance therapy or for maintenance plus reliever therapy.

The starting dose of budesonide - formoterol is based on control of your symptoms. After asthma symptoms are controlled, your doctor will adjust your dose to the lowest regular dose that prevents asthma symptoms.

For maintenance therapy, the recommended dose for adults and adolescents over 12 years of age is 1 to 2 inhalations (or puffs) once or twice daily. If you need fast relief from asthma symptoms, use your fast-acting "reliever" (or "rescue") medication such as formoterol, terbutaline, or salbutamol. The maximum recommended daily maintenance dose is 4 inhalations. When asthma is worsening, the dose can temporarily be increased to a maximum of 4 inhalations twice daily.

For maintenance and reliever therapy, the recommended dose for adults and adolescents over 12 years of age is 1 to 2 inhalations twice daily or 2 inhalations once daily. If you need fast relief from asthma symptoms, use 1 additional inhalation as needed and repeat after a few minutes (to a maximum of 6 inhalations) if symptoms persist. The maximum recommended total daily dose is 8 inhalations.

When used as COPD therapy, the recommended dose is 2 inhalations twice daily. The maximum recommended daily dose is 4 inhalations.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

When used regularly, this medication can reduce the number and severity of episodes of difficulty breathing. Regular daily use is important for its effectiveness.

This medication is inhaled into the lungs through the mouth, using the device that contains the medications (Turbuhaler®). Your health care professional should show you how to use the device. If you not sure about how to use the device, contact your doctor or pharmacist for advice.

Budesonide - formoterol turbuhaler should be used regularly, even when you are not experiencing any symptoms.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, use it as soon as possible and then continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature with the cover on tight, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you are allergic to budesonide, formoterol, or inhaled lactose.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • awareness of heartbeat or fast heartbeat
  • cough
  • dizziness
  • headache
  • hoarseness
  • irritation of the mouth or throat
  • muscle cramps
  • nausea
  • restlessness or nervousness
  • trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bruising
  • chest pain
  • mood or mental changes
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • skin rash or hives all over the body
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • unusual colour, amount, or consistency of phlegm
  • white patches in the mouth or throat (thrush)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • breathlessness when resting
  • rapid heartbeat
  • sudden wheezing and chest pain or tightness immediately after using the medication
  • signs of a severe allergic reaction (e.g., swelling of face, lips, tongue, throat, or eyelids, difficulty swallowing, breathing, or speaking
  • worsening breathing symptoms even after using your reliever medication

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Asthma attacks: This medication works by decreasing the frequency and severity of asthma attacks, and it can be used as a "reliever" medication. If you start developing asthma symptoms, be sure to use your "reliever" medication or an additional inhalation (or puff) of this medication for rapid relief of your asthma symptoms. It is very important that you have your "reliever" medication available with you at all times, whether you're using this medication or another rescue medication. If you persistently use more of your "reliever" medication, contact your doctor.

Asthma-related deaths: Formoterol, as with other long-acting bronchodilators may increase the risk of asthma-related deaths. It is not clear whether using corticosteroids, such as budesonide, reduces this risk. If you have concerns, speak with your doctor.

Heart disease: If you have heart disease or high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: Thrush infections of the inside of the mouth and throat may occur with use of this medication. If an infection develops, call your doctor. You can reduce the risk of infection by rinsing your mouth out with water after each dose and by practicing good oral hygiene. Also, tell your doctor if you are exposed to chicken pox or measles while using this medication, as you may be more prone to infection.

Medical conditions: If you have liver disease, epilepsy, diabetes, or low blood potassium, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Steroid medication use: If you have taken or are still taking steroid medication over the last several months, talk to your doctor before using this medication. In times of stress or during a severe asthma attack, your doctor may want you to start your steroid medication again.

Stopping medication: Do not stop this medication abruptly, as this may cause your condition to get worse. When this medication is stopped, it should be stopped gradually as directed by your doctor.

Thyroid disease: If you have thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if budesonide - formoterol passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children younger than 12 years of age.

What other drugs could interact with this medication?

There may be an interaction between budesonide - formoterol turbuhaler and any of the following:

  • amiodarone
  • atomoxetine
  • azole antifungals (e.g., ketoconazole, itraconazole, fluconazole)
  • amphoteracin B
  • BCG vaccine
  • beta-agonists (e.g., salbutamol, fenoterol, salmeterol, terbutaline)
  • beta-blockers, including eyedrops (e.g., carvedilol, labetalol, metoprolol, propranolol, timolol eye drops)
  • betahistine
  • caffeine
  • clarithromycin
  • dextroamphetamine
  • diabetes medications (e.g., chlorpropamide, glyburide, insulin, rosiglitazone)
  • diuretics (e.g., furosemide, hydrochlorothiazide, spironolactone)
  • dronabinol
  • epinephrine
  • furosemide
  • inhaled anesthetics
  • MAOIs (e.g., moclobemide, selegiline, tranylcypromine)
  • methylphenidate
  • modafinil
  • nabilone
  • nasal decongestants (e.g., oxymetazoline, xylometazoline)
  • protease inhibitors (e.g., indinavir, ritonavir, saquinavir)
  • quetiapine
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin)
  • tacrolimus
  • theophylline
  • tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline)
  • vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.