Tolerability Profile

SYMBICORT has safety data in long-term studies of up to 1 year

Long-term studies demonstrated no significant or unexpected patterns of abnormalities
(observed in patients ≥ 12 years of age taking up to twice the maximum daily dose for up to 1 year)

  • Chemistry
  • Hematology
  • Holter monitor
  • Hypothalamic Pituitary Adrenal (HPA)-axis assessments
  • Electrocardiogram (ECG)
  • The maximum daily recommended dose is 640/18 mcg budesonide/formoterol (given as two inhalations of SYMBICORT 160/4.5 twice daily) for patients 12 years and older. Do not use more than twice daily or use a higher number of inhalations (more than two inhalations twice daily) of the prescribed strength of SYMBICORT as this will result in a daily dose of formoterol in excess of the dose determined to be safe. For all patients, consideration should be given to titrating to the lowest effective strength after adequate asthma stability has been achieved
  • SYMBICORT should not be used more often or at higher doses than recommended. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
  • It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear in a small number of patients, particularly at higher doses

SYMBICORT: Tolerability Profile†

†The incidence of common adverse events in the table above is based upon three 12-week, double-blind, placebo-controlled US clinical trials in which 401 adult and adolescent patients aged 12 years and older were treated twice daily with 2 inhalations of SYMBICORT 80/4.5 mcg or SYMBICORT 160/4/5 mcg, budesonide HFA metered does inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebos (MDI and DPI). Placebos (MDI and pMDI).

‡All treatments were administered as two inhalations twice daily.

Indications and Important Safety Information, including boxed WARNING

  • SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years and older
  • SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma
  • SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta2-agonists
  • WARNING: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. SYMBICORT should only be used for patients with asthma not adequately controlled on other asthma-controller medications (eg, low- to medium- dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS in full Prescribing Information)
  • SYMBICORT does NOT replace fast-acting inhalers and should not be used to treat acute symptoms of asthma
  • SYMBICORT should not be used for transferring patients from systemic corticosteroid therapy. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
  • Patients who are receiving SYMBICORT should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason
  • SYMBICORT should be used with caution in patients with cardiovascular disorders. Some patients may experience and increase in blood pressure or heart rate
  • SYMBICORT, like all medications containing sympathomimetic amines, should be used in caution with patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), untreated hypokalemia, thyrotoxicosis, convulsive disorders, and in patients who are unusually responsive to sympathomimetic amines
  • Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect normal bone metabolism resulting in a loss of bone mineral density. In patients with major risk factors for decreased bone mineral content, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants and corticosteroids), orally inhaled corticosteroids may pose additional risk
  • Rare instances of glaucoma, increase intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT
  • Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT. In US clinical studies, the incidence of lower respiratory tract infections, including pneumonia, was low, with no consistent evidence of increased risk for SYMBICORT, compared to placebo
  • SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks or discontinuation of such agents
  • The most common adverse events ≥5% reported in clinical trials, regardless of relationship to treatment, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort

Please see WARNING in full Prescribing Information

References

  1. SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol prescribing information. AstraZeneca LP.

This product information is intended for US Health Care Professionals only.

SYMBICORT is a registered trademark of the AstraZeneca group of companies.

©2007AstraZeneca LP. All rights reserved. 251677 6/07

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