Medically reviewed on December 1, Symbicort should be administered as 2 inhalations twice daily morning and evening, discharge instructions for acute asthma exacerbations, approximately 12 hours apartevery day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing. Prime Symbicort before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray.
In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well before each spray and releasing two test sprays into the air away from the face.
More frequent administration or a higher number of inhalations more than 2 inhalations twice daily of the prescribed strength of Symbicort is not recommended as some patients are more likely to experience adverse effects with higher doses of formoterol. If asthma symptoms arise in the period between doses, discharge instructions for acute asthma exacerbations, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief. Improvement in asthma control following inhaled administration of Symbicort 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. If a previously effective dosage regimen of Symbicort fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated discharge instructions for acute asthma exacerbations additional therapeutic options, e. If shortness of breath occurs in the period between doses, an inhaled, short-acting beta 2 -agonist should be taken for immediate relief.
Symbicort is available as a metered-dose inhaler containing a combination of budesonide 80 or mcg and formoterol 4. Each strength of Symbicort is supplied with a red plastic actuator with a gray dust cap. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients.
These findings are considered a class effect of LABA. The primary safety endpoint for all four trials was serious asthma-related events hospitalizations, intubations and death.
A blinded adjudication committee determined whether events were asthma-related. There were no asthma-related deaths or intubations. The increased risk of asthma-related death is considered a class effect of LABA monotherapy. The sizes of these studies were not adequate to precisely quantify the difference in serious asthma exacerbations between treatment groups. 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 beta 2 -agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate re-evaluation with reassessment waht does aciphex treat 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 discharge instructions for acute asthma exacerbations of Symbicort.
Symbicort should not be used for the relief of acute symptoms, i. An inhaled, short-acting beta 2 -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 beta 2 -agonists on a regular basis e. As with other inhaled drugs containing beta 2 -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. 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. 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 patients with COPD, there was a higher incidence of lung infections other than pneumonia e.
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. 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 asthma patients 12 months to 8 years of age who were treated with budesonide inhalation suspension 0.
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.
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.
Lung function mean forced expiratory volume in 1 second [FEV 1 ] 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. Some patients may experience symptoms of systemically active corticosteroid withdrawal e. 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 discharge instructions for acute asthma exacerbations for evidence of inadequate adrenal response, discharge instructions for acute asthma exacerbations. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression including adrenal crisis may appear in a small discharge instructions for acute asthma exacerbations of patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time.
If such effects occur, the dosage of Discharge instructions for acute asthma exacerbations should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms. Caution should be exercised when considering the coadministration of Symbicort with ketoconazole, discharge instructions for acute asthma exacerbations, and other known strong CYP3A4 inhibitors e.
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 may occur after administration of Symbicort, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm.
Therefore, Symbicort, triamcinolone acetonide cream an athlete feet all products containing sympathomimetic amines, discharge instructions for acute asthma exacerbations, should be used with caution in patients with cardiovascular disorders, discharge instructions for acute asthma exacerbations, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
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, discharge instructions for acute asthma exacerbations ST segment depression.
The clinical significance of these findings is unknown. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
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, discharge instructions for acute asthma exacerbations, 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.
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 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 month time point were stable over the entire treatment period.
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric accutane side effects surgery. Monitor the growth of pediatric patients receiving Symbicort routinely e. 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.
Ophthalmic examinations were conducted at baseline, 24 weeks, and 52 weeks. 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. A causal relationship between budesonide and these underlying conditions has not been established. 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 discharge instructions for acute asthma exacerbations. Doses of the related beta 2 -adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.
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 The decrease in serum potassium is usually transient, not requiring supplementation. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In considering these data, the increased average duration of patient exposure for Symbicort patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.
Long-term safety - asthma clinical trials in patients 12 years and older. Similarly, no significant or unexpected patterns of abnormalities were observed for up to 1 year in safety measures including chemistry, hematology, discharge instructions for acute asthma exacerbations, ECG, Holter monitor, and HPA-axis assessments.
The safety data for pediatric patients aged 6 to less than 12 years is based on 1 trial of 12 weeks treatment duration. Of these patients were treated for 6 months and were treated for 12 months. In considering these data, the increased average duration of patient exposure to Symbicort should be taken into account, as incidences are not adjusted for an imbalance of treatment discharge instructions for acute asthma exacerbations. There were no clinically important or unexpected patterns of abnormalities observed for up to 1 year in chemistry, hematology, ECG, ECG Holter monitoring, HPA-axis, bone mineral density and ophthalmology assessments.