Budesonide and formoterol inhalation

Usual Adult Dose for Asthma -- Maintenance:

Manufacturer recommendations: 2 oral inhalations twice a day (morning and evening, about 12 hours apart)

The recommended starting dosages are based upon patients' asthma severity.

The maximum recommended dosage is budesonide 160 mcg-formoterol 4.5 mcg twice a day.

Improvement in asthma control following inhaled administration of budesonide-formoterol can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1 to 2 weeks of therapy with Symbicort(R) 80/4.5 (budesonide 80 mcg-formoterol 4.5 mcg), replacement with Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg) may provide additional asthma control.

If a previously effective dosage regimen of budesonide-formoterol fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the lower strength of budesonide-formoterol with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

National Heart, Lung, and Blood Institute (NHLBI) recommendations: 2 oral inhalations twice a day; dose depends on severity of asthma

Budesonide 80 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on low- to medium-dose inhaled corticosteroid therapy.

Budesonide 160 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on medium- to high-dose inhaled corticosteroid therapy.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

For maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema:
Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg): 2 oral inhalations twice a day

Usual Pediatric Dose for Asthma -- Maintenance:

12 years or older:
Manufacturer recommendations: 2 oral inhalations twice a day (morning and evening, about 12 hours apart)

The recommended starting dosages are based upon patients' asthma severity.

The maximum recommended dosage is budesonide 160 mcg-formoterol 4.5 mcg twice a day.

Improvement in asthma control following inhaled administration of budesonide-formoterol can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1 to 2 weeks of therapy with Symbicort(R) 80/4.5 (budesonide 80 mcg-formoterol 4.5 mcg), replacement with Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg) may provide additional asthma control.

If a previously effective dosage regimen of budesonide-formoterol fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the lower strength of budesonide-formoterol with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

NHLBI recommendations: 2 oral inhalations twice a day; dose depends on severity of asthma

Budesonide 80 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on low- to medium-dose inhaled corticosteroid therapy.

Budesonide 160 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on medium- to high-dose inhaled corticosteroid therapy.

(Not approved by FDA)

5 to 11 years:
NHLBI recommendations:
Budesonide 80 mcg-formoterol 4.5 mcg: 2 oral inhalations twice a day

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that budesonide and formoterol is working properly and to check for any unwanted effects that may be caused by budesonide and formoterol. You may need to have your eyes checked at regular visits. Be sure to keep all appointments.

Although budesonide and formoterol 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. budesonide and formoterol 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 budesonide and formoterol 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. budesonide and formoterol 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 budesonide and formoterol 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 budesonide and formoterol. Tell your doctor right away if you or your child have been exposed to someone with chickenpox or measles.

budesonide and formoterol 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 budesonide and formoterol. 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 budesonide and formoterol 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 budesonide and formoterol: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

budesonide and formoterol 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 budesonide and formoterol, check with your doctor as soon as possible.

budesonide and formoterol 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.

budesonide and formoterol may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

budesonide and formoterol 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 budesonide and formoterol 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.

Manufacturer recommendations: 2 oral inhalations twice a day (morning and evening, about 12 hours apart)

The recommended starting dosages are based upon patients' asthma severity.

The maximum recommended dosage is budesonide 160 mcg-formoterol 4.5 mcg twice a day.

Improvement in asthma control following inhaled administration of budesonide-formoterol can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1 to 2 weeks of therapy with Symbicort(R) 80/4.5 (budesonide 80 mcg-formoterol 4.5 mcg), replacement with Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg) may provide additional asthma control.

If a previously effective dosage regimen of budesonide-formoterol fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the lower strength of budesonide-formoterol with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

National Heart, Lung, and Blood Institute (NHLBI) recommendations: 2 oral inhalations twice a day; dose depends on severity of asthma

Budesonide 80 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on low- to medium-dose inhaled corticosteroid therapy.

Budesonide 160 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on medium- to high-dose inhaled corticosteroid therapy.

12 years or older:
Manufacturer recommendations: 2 oral inhalations twice a day (morning and evening, about 12 hours apart)

The recommended starting dosages are based upon patients' asthma severity.

The maximum recommended dosage is budesonide 160 mcg-formoterol 4.5 mcg twice a day.

Improvement in asthma control following inhaled administration of budesonide-formoterol can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief.

For patients who do not respond adequately to the starting dose after 1 to 2 weeks of therapy with Symbicort(R) 80/4.5 (budesonide 80 mcg-formoterol 4.5 mcg), replacement with Symbicort(R) 160/4.5 (budesonide 160 mcg-formoterol 4.5 mcg) may provide additional asthma control.

If a previously effective dosage regimen of budesonide-formoterol fails to provide adequate control of asthma, the therapeutic regimen should be reevaluated and additional therapeutic options (e.g., replacing the lower strength of budesonide-formoterol with the higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.

NHLBI recommendations: 2 oral inhalations twice a day; dose depends on severity of asthma

Budesonide 80 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on low- to medium-dose inhaled corticosteroid therapy.

Budesonide 160 mcg-formoterol 4.5 mcg is recommended for patients who have asthma not controlled on medium- to high-dose inhaled corticosteroid therapy.

(Not approved by FDA)

5 to 11 years:
NHLBI recommendations:
Budesonide 80 mcg-formoterol 4.5 mcg: 2 oral inhalations twice a day

Data not available

The manufacturer recommends close monitoring of patients with hepatic disease.

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, increase the risk of asthma-related death. Use of a LABA alone without use of a long-term asthma control medication (such as an inhaled corticosteroid) is contraindicated in the treatment of asthma. Budesonide-formoterol should only be used for patients with asthma who are 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, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue budesonide-formoterol) if possible without loss of asthma control, and the patient should be maintained on a long-term asthma control medication, such as an inhaled corticosteroid. Budesonide-formoterol should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Budesonide-formoterol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma or chronic obstructive pulmonary disease (COPD) where intensive measures are required. Budesonide-formoterol should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Budesonide-formoterol is not indicated for the relief of acute bronchospasm.

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

Budesonide-formoterol should not be used for the relief of acute symptoms (i.e., as rescue therapy for treatment of acute episodes of bronchospasm). Patients should be provided with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms when budesonide-formoterol is prescribed.

When beginning treatment with budesonide-formoterol, 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.

As with other inhaled drugs containing beta2-adrenergic agents, budesonide-formoterol should not be used more often or 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 with excessive use of inhaled sympathomimetic drugs. Patients using budesonide-formoterol should not use an additional LABA (e.g., salmeterol, formoterol, arformoterol) for any reason, including prevention of exercise-induced bronchospasm or the treatment of asthma or COPD.

Caution is recommended for patients transferred from systemic corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have been reported in asthma patients during and after transfer from systemic corticosteroids to inhaled corticosteroids.

During periods of stress or a severe asthma attack, 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 or a severe asthma attack.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to budesonide-formoterol. Lung function, beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. Patients should also be monitored for signs and symptoms of adrenal insufficiency.

Systemic eosinophilic conditions have been reported rarely in patients using inhaled corticosteroids. Some patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition 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 initiation of inhaled corticosteroids. Patients should be monitored for the development of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy.

The beneficial effects of budesonide-formoterol in minimizing hypothalamic-pituitary-adrenal (HPA) dysfunction may be expected only when recommended dosages are not exceeded and patients are titrated to the lowest effective dose. Systemic corticosteroid effects may appear in a few patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of budesonide-formoterol should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms. Due to the possibility of systemic absorption of inhaled corticosteroids, patients treated with budesonide-formoterol should be observed carefully for any evidence of systemic corticosteroid effects. Patients should be monitored with particular care postoperatively or during periods of stress for inadequate adrenal response.

As with other inhaled asthma medications, budesonide-formoterol may produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs following dosing with budesonide-formoterol, it should be treated at once with an inhaled, short-acting bronchodilator, budesonide-formoterol should be discontinued immediately, and alternate therapy should be instituted.

Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Therefore, budesonide-formoterol, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Formoterol may produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon at recommended doses of formoterol, the drug may need to be discontinued if they occur. Fatalities have been reported with excessive use of inhaled sympathomimetic agents.

Patients using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible patients using corticosteroids. Particular care should be taken to avoid exposure in patients who have not had these diseases or been properly immunized.

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.

Decreases in bone mineral density (BMD) have been reported with long-term use of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal 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 budesonide-formoterol and periodically thereafter. If significant reductions in BMD are seen and budesonide-formoterol is still considered medically important for that patient's COPD therapy, use of medication to treat or prevent osteoporosis should be strongly considered.

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term use of inhaled corticosteroids, including budesonide. Patients with a change in vision or with history of increased intraocular pressure, glaucoma, and/or cataracts should be monitored closely.

Patients with COPD should be monitored for the possible development of pneumonia; clinical features of pneumonia and exacerbations frequently overlap.

In clinical studies with budesonide-formoterol, localized infections with Candida albicans have occurred in the mouth and pharynx. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while treatment with budesonide-formoterol continues, but at times budesonide-formoterol therapy may need to be interrupted. Patients should rinse the mouth after inhalation of budesonide-formoterol.

Budesonide-formoterol, like all agents 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.

Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with budesonide-formoterol at recommended doses.

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Growth should be monitored routinely (e.g., via stadiometry) in pediatric patients receiving budesonide-formoterol. To minimize the systemic effects of budesonide-formoterol, patients should be titrated to the lowest dosage that effectively controls their symptoms.

Safety and effectiveness for the treatment of asthma have not been established in pediatric patients less than 12 years of age. Safety and effectiveness for the treatment of COPD have not been established in pediatric patients (less than 18 years of age).

There are no data on the excretion of budesonide or formoterol into human milk. Other glucocorticoids are excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.