Symbicort

Medications can interact with certain foods.  In some cases, this may be harmful and your doctor may advise you to avoid certain foods.  In the case of Symbicort, there are no specific foods that you must exclude from your diet when receiving this medication.

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. 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 using 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 2 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.

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—2 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 6 to 11 years of age—2 puffs in the morning and another 2 puffs in the evening. Each puff 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 of COPD:
    • Adults—2 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 6 years of age and older—Not used for COPD in this age group.
    • Children younger than 6 years of age—Not used for COPD in this age group.

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.

When you store the inhaler, make sure to always place the mouthpiece down.

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 (eg, 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 (eg, 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 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 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.

• If you have an allergy to budesonide, formoterol, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking or will be taking another drug like this one.

This is not a list of all drugs or health problems that interact with Symbicort.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Symbicort as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For breathing in only.
• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
• Prepare puffer (inhaler) before first use, when puffer has not been used for more than 7 days, or if it has been dropped. Spray 2 test sprays into the air. Shake well before each test spray.
• Shake well before use.
• Rinse out mouth after each use. Do not swallow the rinse water. Spit it out.
• Put the cap back on after you are done using your dose.
• This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when you have been told after opening or when the dose counter has a 0 in it, whichever comes first.
• Never wash the puffer (inhaler). Keep it dry.
• If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
• If you get Symbicort (budesonide and formoterol) in your eyes, wash right away with water. If you have eye irritation that lasts or a change in eyesight, call your doctor.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Chest pain or pressure or a fast heartbeat.
• Very nervous and excitable.
• Bone pain.
• Dizziness or passing out.
• Seizures.
• Very bad headache.
• Shakiness.
• Very upset stomach or throwing up.
• Feeling very tired or weak.
• Not able to sleep.
• A burning, numbness, or tingling feeling that is not normal.
• Flu-like signs.
• Sinus pain.
• Change in eyesight, eye pain, or very bad eye irritation.
• Redness or white patches in mouth or throat.
• Mouth irritation or mouth sores.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using this medicine, use a rescue inhaler and get medical help right away.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Belly pain.
• Stuffy nose.
• Nose or throat irritation.
• Throat pain.
• Back pain.
• Throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

The use of Symbicort is contraindicated in the following conditions:

Asthma-Related Death

LABA, such as formoterol, one of the active ingredients in Symbicort, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, Symbicort should only be used for patients not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Symbicort) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Symbicort for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

A 28-week, placebo controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). This finding with salmeterol is considered a class effect of the LABA, including formoterol, one of the active ingredients in Symbicort. No study adequate to determine whether the rate of asthma-related death is increased with Symbicort has been conducted.

Clinical studies with formoterol suggested a higher incidence of serious asthma exacerbations in patients who received formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.

Deterioration of Disease and Acute Episodes

Symbicort should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Symbicort has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of Symbicort in this setting is not appropriate.

Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of Symbicort with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not use more than 2 inhalations twice daily (morning and evening) of Symbicort.

Symbicort should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not Symbicort, should be used to relieve acute symptoms such as shortness of breath.

When beginning treatment with Symbicort, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.

Excessive Use of Symbicort and Use with Other Long-Acting Beta2-Agonists

As with other inhaled drugs containing beta2-adrenergic agents, Symbicort should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Symbicort should not use an additional LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD.

Local Effects

In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with Symbicort. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while treatment with Symbicort continues, but at times therapy with Symbicort may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.

Pneumonia and Other Lower Respiratory Tract Infections

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids.

In a 6-month lung function study of 1704 patients with COPD, there was a higher incidence of lung infections other than pneumonia (e.g., bronchitis, viral lower respiratory tract infections, etc.) in patients receiving Symbicort 160/4.5 (7.6%) than in those receiving Symbicort 80/4.5 (3.2%), formotero1 4.5 mcg (4.6%) or placebo (3.3%). Pneumonia did not occur with greater incidence in the Symbicort 160/4.5 group (1.1 %) compared with placebo (1.3%). In a 12-month lung function study of 1964 patients with COPD, there was also a higher incidence of lung infections other than pneumonia in patients receiving Symbicort 160/4.5 (8.1%) than in those receiving Symbicort 80/4.5 (6.9%), formoterol 4.5 mcg (7.1%) or placebo (6.2%). Similar to the 6-month study, pneumonia did not occur with greater incidence in the Symbicort 160/4.5 group (4.0%) compared with placebo (5.0%).

Immunosuppression

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered. The immune responsiveness to varicella vaccine was evaluated in pediatric patients with asthma ages 12 months to 8 years with budesonide inhalation suspension.

An open-label, nonrandomized clinical study examined the immune responsiveness to varicella vaccine in 243 asthma patients 12 months to 8 years of age who were treated with budesonide inhalation suspension 0.25 mg to 1 mg daily (n=151) or noncorticosteroid asthma therapy (n=92) (i.e., beta2-agonists, leukotriene receptor antagonists, cromones). The percentage of patients developing a seroprotective antibody titer of >5.0 (gpELISA value) in response to the vaccination was similar in patients treated with budesonide inhalation suspension (85%), compared to patients treated with noncorticosteroid asthma therapy (90%). No patient treated with budesonide inhalation suspension developed chicken pox as a result of vaccination.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Transferring Patients From Systemic Corticosteroid Therapy

Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Symbicort may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress, a severe asthma attack or a severe COPD exacerbation, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress, a severe asthma attack, or a severe COPD exacerbation.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Symbicort. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with Symbicort. Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [PEF]), beta-agonist use, and asthma or COPD symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to inhaled corticosteroids or Symbicort may unmask conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). Some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function.

Hypercorticism and Adrenal Suppression

Budesonide, a component of Symbicort, will often help control asthma and COPD symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Symbicort in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with Symbicort should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of Symbicort should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.

Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors

Caution should be exercised when considering the coadministration of Symbicort with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Paradoxical Bronchospasm and Upper Airway Symptoms

As with other inhaled medications, Symbicort can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Symbicort, it should be treated immediately with an inhaled, short-acting bronchodilator, Symbicort should be discontinued immediately, and alternative therapy should be instituted.

Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of Symbicort, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm.

Cardiovascular and Central Nervous System Effects

Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia [see Overdosage (10)]. Therefore, Symbicort, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Formoterol, a component of Symbicort, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of formoterol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, post menopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care. Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating Symbicort and periodically thereafter. If significant reductions in BMD are seen and Symbicort is still considered medically important for that patient's COPD therapy, use of medication to treat or prevent osteoporosis should be strongly considered.

Effects of treatment with Symbicort 160/4.5, Symbicort 80/4.5, formoterol 4.5 mcg, or placebo on BMD was evaluated in a subset of 326 patients (females and males 41 to 88 years of age) with COPD in the 12-month lung function study. BMD evaluations of the hip and lumbar spine regions were conducted at baseline and 52 weeks using dual energy x-ray absorptiometry (DEXA) scans. Mean changes in BMD from baseline to end of treatment were small (mean changes ranged from -0.01 - 0.01 g/cm2). ANCOVA results for total spine and total hip BMD based on the end of treatment time point showed that all geometric LS Mean ratios for the pairwise treatment group comparisons were close to 1, indicating that overall, BMD for total hip and total spine regions for the 12-month time point were stable over the entire treatment period.

Effect on Growth

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Symbicort routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including Symbicort, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see Dosage and Administration (2.2) and Use in Specific Populations (8.4)].

Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including budesonide, a component of Symbicort. Therefore, close monitoring is warranted in patients with a change in vision or with history of increased intraocular pressure, glaucoma, and/or cataracts.

Effects of treatment with Symbicort 160/4.5, Symbicort 80/4.5, formoterol 4.5 mcg, or placebo on development of cataracts or glaucoma were evaluated in a subset of 461 patients with COPD in the 12-month lung function study. Ophthalmic examinations were conducted at baseline, 24 weeks, and 52 weeks. There were 26 subjects (6%) with an increase in posterior subcapsular score from baseline to maximum value (>0.7) during the randomized treatment period. Changes in posterior subcapsular scores of >0.7 from baseline to treatment maximum occurred in 11 patients (9.0%) in the Symbicort 160/4.5 group, 4 patients (3.8%) in the Symbicort 80/4.5 group, 5 patients (4.2%) in the formoterol group, and 6 patients (5.2%) in the placebo group.

Eosinophilic Conditions and Churg-Strauss Syndrome

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of inhaled corticosteroids. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between budesonide and these underlying conditions has not been established.

Coexisting Conditions

Symbicort, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Hypokalemia and Hyperglycemia

Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology (12.2)]. The decrease in serum potassium is usually transient, not requiring supplementation. Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with Symbicort at recommended doses.

In clinical studies, concurrent administration of Symbicort and other drugs, such as short-acting beta2-agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with Symbicort.

Inhibitors of Cytochrome P4503A4

The main route of metabolism of corticosteroids, including budesonide, a component of Symbicort, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of CYP3A4 may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of Symbicort with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9)].

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants

Symbicort should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of Symbicort, on the vascular system may be potentiated by these agents. In clinical trials with Symbicort, a limited number of COPD and asthma patients received tricyclic antidepressants, and, therefore, no clinically meaningful conclusions on adverse events can be made.

Beta-Adrenergic Receptor Blocking Agents

Beta-blockers (including eye drops) may not only block the pulmonary effect of beta-agonists, such as formoterol, a component of Symbicort, but may produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Diuretics

The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of Symbicort with non-potassium-sparing diuretics.

Asthma

Patients with asthma 12 years of age and older

In two clinical studies comparing Symbicort with the individual components, improvements in most efficacy end points were greater with Symbicort than with the use of either budesonide or formoterol alone. In addition, one clinical study showed similar results between Symbicort and the concurrent use of budesonide and formoterol at corresponding doses from separate inhalers.

The safety and efficacy of Symbicort were demonstrated in two randomized, double-blind, placebo-controlled US clinical studies involving 1076 patients 12 years of age and older. Fixed Symbicort dosages of 160/9 mcg, and 320/9 mcg twice daily (each dose administered as 2 inhalations of the 80/4.5 and 160/4.5 mcg strengths, respectively) were compared with the monocomponents (budesonide and formoterol) and placebo to provide information about appropriate dosing to cover a range of asthma severity.

Study 1: Clinical Study with Symbicort 160/4.5

This 12-week study evaluated 596 patients 12 years of age and older by comparing Symbicort 160/4.5, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, budesonide 160 mcg, formoterol 4.5 mcg, and placebo; each administered as 2 inhalations twice daily. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids prior to study entry. Randomization was stratified by previous inhaled corticosteroid treatment (71.6% on moderate- and 28.4% on high-dose inhaled corticosteroid). Mean percent predicted FEV1 at baseline was 68.1% and was similar across treatment groups. The co-primary efficacy end points were 12-hour-average post-dose FEV1 at week 2, and pre-dose FEV1 averaged over the course of the study. The study also required that patients who satisfied a predefined asthma-worsening criterion be withdrawn. The predefined asthma-worsening criteria were a clinically important decrease in FEV1 or PEF, increase in rescue albuterol use, nighttime awakening due to asthma, emergency intervention or hospitalization due to asthma, or requirement for asthma medication not allowed by the protocol. For the criterion of nighttime awakening due to asthma, patients were allowed to remain in the study at the discretion of the investigator if none of the other asthma-worsening criteria were met. The percentage of patients withdrawing due to or meeting predefined criteria for worsening asthma is shown in Table 3.

Mean percent change from baseline in FEV1 measured immediately prior to dosing (pre-dose) over 12 weeks is displayed in Figure 1. Because this study used predefined withdrawal criteria for worsening asthma, which caused a differential withdrawal rate in the treatment groups, pre-dose FEV1 results at the last available study visit (end of treatment, EOT) are also provided. Patients receiving Symbicort 160/4.5 had significantly greater mean improvements from baseline in pre-dose FEV1 at the end of treatment (0.19 L, 9.4%), compared with budesonide 160 mcg (0.10 L, 4.9%), formoterol 4.5 mcg (-0.12 L, -4.8%), and placebo (-0.17 L, -6.9%).

Figure 1 Mean Percent Change From Baseline in Pre-dose FEV1 Over 12 Weeks (Study 1)

The effect of Symbicort 160/4.5 two inhalations twice daily on selected secondary efficacy variables, including morning and evening PEF, albuterol rescue use, and asthma symptoms over 24 hours on a 0-3 scale is shown in Table 4.

The subjective impact of asthma on patients’ health-related quality of life was evaluated through the use of the standardized Asthma Quality of Life Questionnaire (AQLQ(S)) (based on a 7-point scale where 1 = maximum impairment and 7 = no impairment). Patients receiving Symbicort 160/4.5 had clinically meaningful improvement in overall asthma-specific quality of life, as defined by a mean difference between treatment groups of >0.5 points in change from baseline in overall AQLQ score (difference in AQLQ score of 0.70 [95% CI 0.47, 0.93], compared to placebo).

Study 2: Clinical Study with Symbicort 80/4.5

This 12-week study was similar in design to Study 1, and included 480 patients 12 years of age and older. This study compared Symbicort 80/4.5, budesonide 80 mcg, formoterol 4.5 mcg, and placebo; each administered as 2 inhalations twice daily. The study included a 2-week placebo run-in period. Most patients had mild to moderate asthma and were using low to moderate doses of inhaled corticosteroids prior to study entry. Mean percent predicted FEV1 at baseline was 71.3% and was similar across treatment groups. Efficacy variables and end points were identical to those in Study 1.

The percentage of patients withdrawing due to or meeting predefined criteria for worsening asthma is shown in Table 5. The method of assessment and criteria used were identical to that in Study 1.

Mean percent change from baseline in pre-dose FEV1 over 12 weeks is displayed in Figure 2.

Figure 2 Mean Percent Change From Baseline in Pre-dose FEV1 Over 12 Weeks (Study 2)

Efficacy results for other secondary end points, including quality of life, were similar to those observed in Study 1.

Onset and Duration of Action and Progression of Improvement in Asthma Control

The onset of action and progression of improvement in asthma control were evaluated in the two pivotal clinical studies. The median time to onset of clinically significant bronchodilation (>15% improvement in FEV1) was seen within 15 minutes. Maximum improvement in FEV1 occurred within 3 hours, and clinically significant improvement was maintained over 12 hours. Figures 3 and 4 show the percent change from baseline in post-dose FEV1 over 12 hours on the day of randomization and on the last day of treatment for Study 1.

Reduction in asthma symptoms and in albuterol rescue use, as well as improvement in morning and evening PEF, occurred within 1 day of the first dose of Symbicort; improvement in these variables was maintained over the 12 weeks of therapy.

Following the initial dose of Symbicort, FEV1 improved markedly during the first 2 weeks of treatment, continued to show improvement at the Week 6 assessment, and was maintained through Week 12 for both studies.

No diminution in the 12-hour bronchodilator effect was observed with either Symbicort 80/4.5 or Symbicort 160/4.5, as assessed by FEV1, following 12 weeks of therapy or at the last available visit.

FEV1 data from Study 1 evaluating Symbicort 160/4.5 is displayed in Figures 3 and 4.

Figure 3 Mean Percent Change From Baseline in FEV1 on Day of Randomization (Study 1)

Figure 4 Mean Percent Change From Baseline in FEV1 At End of Treatment (Study 1)

Patients with asthma 6 to less than 12 years of age

The clinical program to support the efficacy of Symbicort 80/4.5 in children 6 to less than 12 years of age included the following: 1) a budesonide dose confirmatory study, 2) a formoterol dose finding study, and 3) an efficacy and safety study of the Symbicort combination product.

The selection of budesonide 80 mcg is supported by a 6-week, randomized, double-blind, placebo-controlled study in 304 pediatric patients (152 budesonide, 152 placebo) 6 to less than 12 years of age with asthma. Results showed that budesonide 80 mcg (2 inhalations twice daily) provided statistically significantly greater improvement compared to placebo for the primary endpoint of change from baseline to the treatment period average in pre-dose morning PEF and the key secondary endpoint of change in pre-dose morning FEV1. The selection of the formoterol dose is supported by a randomized, single dose, placebo-controlled, active-controlled (Foradil Aerolizer 12 mcg), 5-way cross-over study in which doses of 2.25, 4.5 and 9 mcg formoterol were administered in combination with budesonide in 54 pediatric patients 6 to less than 12 years of age with asthma. Results showed a dose response of formoterol compared to placebo for the primary endpoint of FEV1 averaged over 12 hours post-dose and the 9 mcg group showed numerically similar results compared to the active control.

The confirmatory efficacy study was a 12-week, randomized, double-blind, multicenter study in which Symbicort 80/4.5 was compared with budesonide pMDI 80 mcg, each administered as 2 inhalations twice daily, in 184 pediatric patients 6 to less than 12 years of age with a documented clinical diagnosis of asthma. At trial entry, the children had a requirement for daily medium-dose range inhaled corticosteroid therapy or fixed combination of inhaled corticosteroid and LABA therapy, and exhibited symptoms despite treatment with a low-dose inhaled corticosteroid during a 2 to 4 week run-in period. The primary efficacy variable was change from baseline to Week 12 in clinic-measured 1-hour post-dose FEV1. In patients receiving Symbicort 80/4.5, there was a statistically significant change compared to budesonide in 1-hour post-dose FEV1 which improved by 0.28 L from baseline to Week 12, as compared with 0.17 L for those receiving budesonide 80 mcg (mean difference 0.12 L; 95% CI: 0.03, 0.20) (see Figure 5).

Figure 5 Change From Baseline in Clinic-Measured 1-hour Post-dose FEV1 over 12 Weeks (Efficacy and Safety Study in Patients 6 to less than 12 years of age).

Similarly, improvement was noted in change from baseline to Week 12 for 1-hour post-dose clinic PEF (mean difference 25.5 L/min; 95% CI: 10.9, 40.0). Bronchodilatory effects were evident from the first assessment at 15 minutes on day 1 and were maintained at Week 12. The estimated mean difference between Symbicort 80/4.5 and budesonide with respect to change from baseline to Week 12 in 15 minutes post-dose clinic FEV1 was 0.10 L (95% CI: 0.02, 0.18). No differences between Symbicort and budesonide were noted in nighttime awakenings, rescue albuterol use, or Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores. The proportion of patients with at least 0.5 points improvement from baseline to Week 12 in PAQLQ was 42% on Symbicort 80/4.5 and 46% on budesonide 80 mcg.

Chronic Obstructive Pulmonary Disease

Lung Function

The efficacy of Symbicort 80/4.5 and Symbicort 160/4.5 in the maintenance treatment of airflow obstruction in COPD patients was evaluated in two randomized, double-blind, placebo-controlled multinational studies, conducted over 6 months (Study 1) and 12 months (Study 2), in a total of 3668 patients (2416 males and 1252 females). The majority of patients (93%) were Caucasian. All patients were required to be at least 40 years of age, with a FEV1 of less than or equal to 50% predicted, a clinical diagnosis of COPD with symptoms for at least 2 years, and a smoking history of at least 10 pack years, prior to entering the trial. The mean prebronchodilator FEV1 at baseline of the patients enrolled in the study was 34% predicted. Forty-eight percent of the patients enrolled were on inhaled corticosteroids and 52.7% of patients were on short-acting anticholinergic bronchodilators during run-in. On randomization, inhaled corticosteroids were discontinued, and ipratropium bromide was allowed at a stable dose for those patients previously treated with short-acting anticholinergic bronchodilators. The co-primary efficacy variables in both studies were the change from baseline in average pre-dose and 1-hour post-dose FEV1 over the treatment period. The results of both studies 1 and 2 are described below.

Study 1

This was a 6-month, placebo-controlled study of 1704 COPD patients (mean % predicted FEV1 at baseline ranging from 33.5% -34.7%) conducted to demonstrate the efficacy and safety of Symbicort in the treatment of airflow obstruction in COPD. The patients were randomized to one of the following treatment groups: Symbicort 160/4.5 (n=277), Symbicort 80/4.5 (n=281), budesonide 160 mcg + formoterol 4.5 mcg (n=287), budesonide 160 mcg (n=275), formoterol 4.5 mcg (n=284), or placebo (n=300). Patients receiving Symbicort 160/4.5, two inhalations twice daily, had significantly greater mean improvements from baseline in pre-dose FEV1 averaged over the treatment period [0.08 L, 10.7%] compared with formoterol 4.5 mcg [0.04 L, 6.9%] and placebo [0.01 L, 2.2%] (see Figure 6). Patients receiving Symbicort 80/4.5, two inhalations twice daily, did not have significantly greater improvement from baseline in the pre-dose FEV1 averaged over the treatment period compared with formoterol 4.5 mcg.

Figure 6 Mean Percent Change From Baseline in Pre-dose FEV1 Over 6 months (Study 1)

Patients receiving Symbicort 160/4.5, two inhalations twice daily, had significantly greater mean improvements from baseline in 1-hour post-dose FEV1 averaged over the treatment period [0.20 L, 22.6%], compared with budesonide 160 mcg [0.03 L, 4.9%] and placebo [0.03 L, 4.1%] (see Figure 7).

Figure 7 Mean Percent Change From Baseline in 1-hour Post-dose FEV1 Over 6 months (Study 1)

Study 2

This was a 12-month, placebo-controlled study of 1964 COPD patients (mean % predicted FEV1 at baseline ranging from 33.7% -35.5%) conducted to demonstrate the efficacy and safety of Symbicort in the treatment of airflow obstruction in COPD. The patients were randomized to one of the following treatment groups: Symbicort 160/4.5 (n=494), Symbicort 80/4.5 (n=494), formoterol 4.5 mcg (n=495), or placebo (n=481). Patients receiving Symbicort 160/4.5, two inhalations twice daily, had significantly greater improvements from baseline in mean pre-dose FEV1 averaged over the treatment period [0.10 L, 10.8%] compared with formoterol 4.5 mcg [0.06 L, 7.2%] and placebo [0.01 L, 2.8%]. Patients receiving Symbicort 80/4.5, two inhalations twice daily, did not have significantly greater improvements from baseline in the mean pre-dose FEV1 averaged over the treatment period compared to formoterol. Patients receiving Symbicort 160/4.5, two inhalations twice daily, also had significantly greater mean improvements from baseline in 1-hour post-dose FEV1 averaged over the treatment period [0.21 L, 24.0%] compared with placebo [0.02 L, 5.2%].

Serial FEV1 measures over 12 hours were obtained in a subset of patients in Study 1 (n=99) and Study 2 (n=121). The median time to onset of bronchodilation, defined as an FEV1 increase of 15% or greater from baseline, occurred at 5 minutes post-dose. Maximum improvement (calculated as the average change from baseline at each timepoint) in FEV1 occurred at approximately 2 hours post-dose.

In both Studies 1 and 2, improvements in secondary endpoints of morning and evening peak expiratory flow and reduction in rescue medication use were supportive of the efficacy of Symbicort 160/4.5.

Exacerbations

Studies 3 and 4 were primarily designed to evaluate the effect of Symbicort 160/4.5 on COPD exacerbations.

Study 3

This was a 6-month, active-control study conducted to evaluate the effect of Symbicort 160/4.5 compared to formoterol 4.5 mcg, each administered as 2 inhalations twice daily, on the rate of moderate and severe COPD exacerbations. COPD exacerbations were defined as worsening of 2 or more major symptoms (dyspnea, sputum volume, sputum color/purulence) or worsening of any 1 major symptom together with at least 1 of the minor symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, increased cough or increased wheeze for at least 2 consecutive days. COPD exacerbations were considered of moderate severity if treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics were required, and were considered severe if hospitalization was required. The study randomized 1219 subjects to Symbicort 160/4.5 (606) and formoterol 4.5 mcg (613) of which 57% were male and 92% were Caucasian. They had a mean age of 64 years and a median smoking history of 39 pack years, with 46% identified as current smokers. At run-in, the mean post-bronchodilator % predicted normal FEV1 was 48.7% (range: 16.0% to 78.1%), and patients had a history of at least 1 COPD exacerbation in the previous year treated with systemic corticosteroids and/or hospitalization. All subjects were treated with Symbicort 160/4.5, two inhalations twice daily during a 4-week run-in period prior to being assigned trial treatment.

Study 4

This was a 12-month, active-control study which included 811 subjects treated with Symbicort 160/4.5 or formoterol 4.5 mcg, each administered as 2 inhalations twice daily. The study was conducted to evaluate for COPD exacerbation reduction in patients with COPD. COPD exacerbations were defined as worsening of COPD that required a course of oral steroids for treatment and/or hospitalization. This study randomized 407 subjects to Symbicort 160/4.5 and 404 to formoterol 4.5 mcg of which 61% were male and 83% were Caucasian. They had a mean age of 63 years and a median smoking history of 45 pack years, with 36% identified as current smokers. At run-in, the mean post-bronchodilator % predicted normal FEV1 was 37.8% (range: 11.75% to 76.50%), and a history of at least 1 COPD exacerbation in the previous year treated with systemic corticosteroids and/or antibiotics.

In Study 3, subjects treated with Symbicort 160/4.5, two inhalations twice daily had a significantly lower annual rate of moderate/severe COPD exacerbations compared with formoterol 4.5 mcg with a reduction of 26% (95% CI: 9%, 39%). In Study 4, a significantly lower annual rate of exacerbations was also observed in subjects treated with Symbicort 160/4.5 compared with formoterol 4.5 mcg with a reduction of 35% (95% CI: 20%, 47%) (Table 6).

n – Number of patients included in efficacy analysis set.

Health-related quality of life was measured using the St. George’s Respiratory Questionnaire (SGRQ) in both COPD exacerbation clinical studies.

In Study 3, the SGRQ responder rates at 6-months (defined as an improvement in score of 4 or more as a threshold) were 40% and 33% for Symbicort 160/4.5 and formoterol 4.5 mcg, respectively, with an odds ratio of 1.5 (95% CI: 1.0, 2.0) for Symbicort 160/4.5 vs. formoterol 4.5 mcg. In Study 4, the responder rates at 12-months were 50% and 49% for Symbicort 160/4.5 and formoterol 4.5 mcg, respectively, with an odds ratio of 1.0 (95% CI: 0.8, 1,4) for Symbicort 160/4.5 vs. formoterol 4.5 mcg.

NDC 0186-0370-20

Store Upright

Symbicort® 160/4.5

budesonide 160 mcg/formoterol fumarate dehydrate 4.5 mcg

INHALATION AEROSOL

120 inhalations

For Oral Inhalation only

Dispense with enclosed Medication Guide.

Rx only

Mfd. for: AstraZeneca LP, Wilmington, DE 19850

By: AstraZeneca Dunkerque Production

Dunkerque, France          Product of France

AstraZeneca

If Symbicort 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, Dulera, Perforomist), or a similar long-acting bronchodilator such as salmeterol (Serevent, Advair) or arformoterol (Brovana).

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.

Applies to budesonide / formoterol: inhalation aerosol

Respiratory

Respiratory side effects have included nasopharyngitis, upper and lower respiratory tract infection, sinusitis, nasal and sinus congestion, pharyngitis, allergic rhinitis,acute bronchitis, asthma,and pharyngolaryngeal pain.[Ref]

Gastrointestinal

Gastrointestinal side effects have included stomach discomfort, vomiting, nausea, viral gastroenteritis, dyspepsia, upper abdominal pain, and diarrhea.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain, muscle spasms, arthralgia, myalgia, and pain in the extremities.[Ref]

Genitourinary

Genitourinary side effects have included urinary tract infections.[Ref]

Nervous system

Nervous system side effects have included tension headache, dizziness, sinus headache and migraine.[Ref]

General

General side effects have included oral candidiasis, dysphonia, and pyrexia.[Ref]

Some side effects of Symbicort may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Symbicort is a combination of two drugs in a single form used to treat asthma. It’s also used to treat chronic obstructive pulmonary disease (COPD).

It is available in this form: an inhalation aerosol, which is packaged in a metered dose inhaler (MDI).

Symbicort is a brand-name drug. It isn’t available as a generic drug.

This drug doesn’t relieve sudden symptoms of your condition. Always have a rescue inhaler with you to treat sudden symptoms. If you don’t have a rescue inhaler, ask your doctor to prescribe one for you.

The more common side effects of Symbicort include throat irritation and pain, mouth, throat, and upper respiratory tract infections, and inflammation in the sinuses (sinusitis).

• FDA warning See Details

• Sudden shortness of breath See Details

• When to seek emergency help See Details

• Other long-acting beta2-agonists (LABAs) See Details

What is Symbicort?

This drug is a prescription drug. It is available as an inhalation aerosol, which is packaged in a metered dose inhaler (MDI).

This drug is not available as a generic drug. It’s only available as the brand-name drug called Symbicort.

This drug is a combination drug. It contains two drugs: budesonide and formoterol. It’s important to know about all the drugs in the combination because each drug may affect you in a different way.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to control and prevent symptoms of asthma, such as wheezing, in adults and children ages 12 years and older. This drug shouldn’t be used to treat asthma attacks. You should use a rescue inhaler to treat sudden symptoms of asthma.

More Details

How it works

This drug belongs to two classes of drugs. Budesonide belongs to a class of drugs called inhaled corticosteroids and formoterol belongs to a class of drugs called long acting beta2-adrenergic agonists (LABA). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

More Details