Generic Name: budesonide and formoterol (Inhalation route)
bue-DES-oh-nide, for-MOE-ter-ol FUE-ma-rate
Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, budesonide/formoterol fumarate should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta(2)-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta(2)-adrenergic agonist), one of the active ingredients in budesonide/formoterol fumarate .
Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related deaths. Therefore, when treating patients with asthma, budesonide/formoterol fumarate should only be used for patients not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination
Pharmacologic Class: Adrenal Glucocorticoid
Budesonide and formoterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.
This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.
Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.
Inhaled formoterol belongs to the family of medicines known as bronchodilators. It works by helping the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide and formoterol combination in children. However, safety and efficacy have not been established in children below 12 years of age. .
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide and formoterol combination in the elderly. However, elderly patients with heart problems may require special caution when receiving budesonide and formoterol combination.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain budesonide and formoterol. It may not be specific to Symbicort 200 Turbuhaler. Please read with care.
This medicine is used with a special inhaler and usually comes with patient directions or a Medication Guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.
Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.
When you use the inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine two times into the air away from the face, and shaking it well for 5 seconds before each spray.
How to use this medicine:
Each inhaler comes with a dose tracker card to track the number of puffs you have used. Mark off or punch through each of your morning and evening doses. You must discard the inhaler after you have used the number of inhalations on the product label and box, or within 3 months of opening the foil pouch.
Clean the inhaler every 7 days by wiping the mouthpiece with dry cloth. However, you must use a new inhaler with each refill of your medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
When you store the inhaler, make sure to always place the mouthpiece down.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by this medicine.
Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor or pharmacist about any questions or concerns that you have.
You should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.
Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with salmeterol (Serevent®), formoterol (Perforomist™), or arformoterol (Brovana®) inhalers.
Talk to your doctor or get medical care right away if:
Do not change your doses or stop using your medicines without asking your doctor.
Your doctor may want you to carry a medical identification card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.
You may get infections more easily while using this medicine. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.
Patients with COPD may be more likely to have pneumonia. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing.
If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.
This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.
This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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