Brand Name
US Brand Name
Symbicort
Symbicort Aerosphere
Canadian Brand Name
Symbicort 100 Turbuhaler
Symbicort 200 Turbuhaler
Description
Budesonide and formoterol combination is 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.
Budesonide and formoterol combination is also used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.
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.
Formoterol belongs to the family of medicines known as long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Aerosol Liquid
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Symbicort Aerosphere® inhaler in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Symbicort® inhaler in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Symbicort Aerosphere® inhaler in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Symbicort® inhaler in the elderly. However, elderly patients with heart problems may require special caution when receiving budesonide and formoterol combination.
Breastfeeding
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.
Drug Interactions
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.
- Bepridil
- Cisapride
- Desmopressin
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Rotavirus Vaccine, Live
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Acebutolol
- Adagrasib
- Alfuzosin
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atenolol
- Avacopan
- Azithromycin
- Balofloxacin
- Bedaquiline
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Berotralstat
- Besifloxacin
- Betaxolol
- Bisoprolol
- Boceprevir
- Bumetanide
- Buprenorphine
- Bupropion
- Buserelin
- Carbamazepine
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.
- Auranofin
- Erythromycin
Other Interactions
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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.
- Cataracts or
- Diabetes or
- Glaucoma or
- Heart or blood disease or
- Heart rhythm problems (eg, arrhythmia) or
- Hypertension (high blood pressure) or
- Hyperglycemia (high blood sugar) or
- Hypokalemia (low potassium in the blood) or
- Immune system problem (eg, Churg-Strauss syndrome) or
- Ketoacidosis (high ketones in the blood) or
- Osteoporosis, history of or
- Seizures or
- Thyroid problems—Use with caution. May make these conditions worse.
- Chickenpox (including recent exposure) or
- Herpes simplex (virus) infection of the eye or
- Infections (eg, virus, bacteria, or fungus) or
- Measles (including recent exposure) or
- Tuberculosis, active or history of—Can reduce the body's ability to fight off these infections.
- Electrolyte imbalance or
- Infection (eg, gastroenteritis) or
- Stress or
- Surgery or
- Trauma—Supplementary oral corticosteroids may be needed. 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
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop using this medicine without telling your doctor. To do so may make your condition worse.
Inhaled fluticasone and salmeterol is used to prevent asthma attacks and treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.
This medicine comes with a patient information leaflet or patient instructions. 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. Also, ask your doctor to check regularly how you use the inhaler to make sure you are using it properly.
In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.
When you use the Symbicort® 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 inhalation. Therefore, before using the inhaler, prime it by spraying the medicine 2 times into the air away from the face, and shaking it well for 5 seconds before each spray.
To use the Symbicort® inhaler:
- 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.
- 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 for 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 inhalation following exactly the same steps you used for the first inhalation.
- 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.
- Clean the inhaler every 7 days by wiping the mouthpiece with a dry cloth. Do not put the inhaler into water or try to take it apart. However, you must use a new inhaler with each refill of your medicine.
The dose counter at the top of the Symbicort® inhaler will turn yellow when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.
When you use the Symbicort Aerosphere® inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine 4 times into the air away from the face, and shaking it well before each spray. If you have not used it for 7 days or longer or if you've dropped it, re-prime by spraying the medicine 2 times into the air away from the face, and shaking it well before each spray.
To use the Symbicort Aerosphere® inhaler:
- This medicine comes in a sealed foil pouch. Do not open the foil pouch until you are ready to use a dose of this medicine.
- Once opened, remove the inhaler from the pouch.
- Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear.
- Press the center of the dose indicator all the way down and release it. You may hear a soft click from the dose indicator as it counts down during use.
- To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until the canister stops moving in the actuator and a puff of medicine has been released.
- Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose.
- Rinse your mouth with water after each dose. This will help prevent infection in the mouth. Do not swallow the water after rinsing.
- Clean the actuator at least once a week with warm water for 30 seconds. Shake off the excess water. Let the actuator air-dry overnight. Do not let the canister get wet.
The dose display window of the Symbicort Aerosphere® inhaler will turn red when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 months since you last opened the foil pouch.
Dosing
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 inhalation contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
- Children 6 to 11 years of age—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 80 mcg of budesonide and 4.5 mcg of formoterol.
- Children younger than 6 years of age—Use and dose must be determined by your child's doctor.
- For treatment and prevention of worsening attacks of COPD:
- Adults—Two puffs in the morning and another 2 puffs in the evening. Each inhalation contains 160 micrograms (mcg) of budesonide and 4.8 mcg of formoterol.
- Children—Use and dose must be determined by your doctor.
- For preventing an asthma attack:
Missed Dose
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.
Storage
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.
Store the inhaler with the mouthpiece down.
Precautions
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. Blood and urine tests may be needed to check for any unwanted effects.
Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma attack when they do occur. Be sure to read about these risks in the patient information leaflet and talk to your doctor about any questions or concerns that you have.
This medicine should not be used if you are having a sudden COPD attack, or if symptoms of COPD attack has already started. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, tell your doctor right away.
Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
Talk to your doctor or get medical care right away if:
- Your symptoms do not improve after using this medicine for a few days 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.
Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), olodaterol, salmeterol (Serevent®), or vilanterol.
Do not change your dose or stop using your medicine without first asking 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 or your child 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 or your child are having a cough, difficulty with breathing, or wheezing.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.
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 cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.
Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
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 (ID) 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
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
- Body aches or pain
- chest tightness
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- pain or tenderness around the eyes and cheekbones
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- congestion
- cough producing mucus
- diarrhea
- 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
- hoarseness
- joint pain
- loss of appetite
- lower back or side pain
- nausea
- noisy breathing
- shakiness in the legs, arms, hands, or feet
- shivering
- sore mouth or tongue
- stomach pain
- sweating
- tender, swollen glands in the neck
- trembling or shaking of the hands or feet
- trouble with sleeping
- trouble with swallowing
- voice changes
- vomiting
- white patches in the mouth or on the tongue
Rare
- Blurred vision
- confusion
- decreased urine
- dizziness or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- enlarged pupils
- fainting
- 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
- muscle cramps
- nervousness
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- seizures
- severe chest pain
- severe headache
- slow, fast, pounding, or irregular heartbeat or pulse
- stiff or sore neck
- unexplained weight loss
Incidence not known
- Blindness
- decreased vision
- eye pain
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tearing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Arm, back, or jaw pain
- chest pain or discomfort
- darkening of the skin
- drowsiness
- mental depression
- rapid, deep breathing
- restlessness
- skin rash
- stomach cramps
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
- Stomach discomfort
Less common
- Belching
- difficulty with moving
- heartburn
- indigestion
- muscle spasms or stiffness
- pain in the arms or legs
- stomach upset
- swollen joints
Rare
- Bad, unusual, or unpleasant (after) taste
- change in taste
- deep or fast breathing with dizziness
- fear
- hives or welts, itching skin
- irritability
- large, flat, blue, or purplish patches in the skin
- numbness in the feet, hands, and around the mouth
- redness of the skin
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.
CON-XXXXXXXX
