Budesonide and formoterol (Inhalation route)
bue-DES-oh-nide, for-MOE-ter-ol FUE-ma-rate
- Symbicort 100 Turbuhaler
- Symbicort 200 Turbuhaler
- Aerosol Liquid
Antiasthma, Anti-Inflammatory/Bronchodilator Combination
Uses of This Medicine:
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.
Before Using This Medicine:
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 younger than 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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
- Arsenic Trioxide
- Eslicarbazepine Acetate
- Methylene Blue
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
Other medical problems—
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:
- Asthma attack, acute or
- Bronchospasm (difficulty with breathing), acute or
- COPD flare-up—Should not be used in patients with these conditions.
- Bone problems (e.g., osteoporosis) or
- Cataracts or
- Glaucoma or
- Heart or blood vessel disease or
- Heart rhythm problems or
- Hypertension (high blood pressure) or
- Hypokalemia (low potassium in the blood) or
- Immune system problem (e.g., Churg-Strauss syndrome) or
- Seizures or
- Thyroid problems—Use with caution. May make these conditions worse.
- Chickenpox (including recent exposure) or
- Measles or
- Herpes simplex (virus) infection of the eye or
- Infections (virus, bacteria, or fungus) or
- Tuberculosis, active or history of—Can reduce the body's ability to fight off these infections.
- Diabetes mellitus or
- Hyperglycemia (high glucose in the blood) or
- Ketoacidosis (high ketones in the blood)—Blood sugar levels may increase.
- Infection or
- Stress or
- Surgery or
- Trauma—Oral corticosteroids may be needed during these periods. Check with your doctor.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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:
- Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.
- Do not use the inhaler for this medicine with any other medicine.
- Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.
- Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.
- Holding the inhaler level, put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
- While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
- Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
- Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
- Shake the inhaler again for 5 seconds and take the second puff following exactly the same steps you used for the first puff.
- Replace the mouthpiece cover after using the medicine.
- Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.
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.
- For inhalation dosage form (aerosol):
- For preventing an asthma attack:
- Adults and children 12 years of age and older—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
- Children younger than 12 years of age—Use and dose must be determined by your child's doctor.
- For treatment of COPD:
- Adults—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
- Children 12 years of age and older—Not used for COPD in this age group.
- Children younger than 12 years of age—Not used for COPD in this age group.
- For preventing an asthma attack:
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.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.
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 about any questions or concerns that you have.
This should not be the first and only medicine you use for asthma or COPD. This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma attack or an acute COPD flare-up. If the other medicine does not work as well, tell your doctor right away.
Take all of your COPD medicines as your doctor ordered. If you use any type of corticosteroid medicine to control your breathing, keep using it as ordered by your doctor. Do not change your doses or stop using your medicines without asking your doctor.
You or your child 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:
- Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.
- Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (e.g.; you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
- You or your child have a significant decrease in your peak flow when measured as directed by your doctor.
You may get infections more easily while using this medicine. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.
This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.
Patients with COPD may be more likely to have pneumonia when taking this medicine. 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 or your child 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.
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 or your child 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 and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.
Your doctor may want you to carry a medical identification card stating that you or your child 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.
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.
Side Effects of This Medicine:
- More common
- Body aches or pain
- cough, fever, sneezing, or sore throat
- difficulty with breathing
- ear congestion
- loss of voice
- muscle aches
- pain or tenderness around the eyes and cheekbones
- shortness of breath or troubled breathing
- stuffy or runny nose
- tightness of the chest or wheezing
- unusual tiredness or weakness
- Less common
- Abdominal or stomach pain
- bladder pain
- bloody or cloudy urine
- cough producing mucus
- difficult, burning, or painful urination
- dryness of the throat
- fast, irregular, pounding, or racing heartbeat or pulse
- frequent urge to urinate
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- lower back or side pain
- noisy breathing
- shakiness in the legs, arms, hands, or feet
- sore mouth or tongue
- tender, swollen glands in the neck
- trembling or shaking of the hands or feet
- trouble with swallowing
- trouble with sleeping
- voice changes
- white patches in the mouth or on the tongue
- Blurred vision
- decreased urine
- dizziness or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- enlarged pupils
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased sensitivity of the eyes to light
- increased sweating, possibly with fever or cold, clammy skin
- increased thirst
- increased urination
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- mood changes
- muscle cramps
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- severe chest pain
- severe headache
- slow, fast, pounding, or irregular heartbeat or pulse
- stiff or sore neck
- unexplained weight loss
- Incidence not known
- decreased vision
- eye pain
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- Symptoms of overdose
- Arm, back, or jaw pain
- chest pain or discomfort
- darkening of the skin
- mental depression
- rapid, deep breathing
- skin rash
- stomach cramps
- unable to sleep
- More common
- Stomach discomfort
- Less common
- Acid or sour stomach
- difficulty with moving
- muscle spasms or stiffness
- pain in the arms or legs
- stomach upset
- swollen joints
- Bad, unusual, or unpleasant (after) taste
- change in taste
- deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
- hives or welts
- itching skin
- large, flat, blue, or purplish patches in the skin
- redness of the skin
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 11/4/2014