SYMBICORT 160/4.5 for the maintenance treatment of COPD and for reducing COPD exacerbations

SYMBICORT for asthma patients ≥12 years of age uncontrolled on an ICS

SYMBICORT Inhalers
COPD DOSE1
160/4.5 mcg 2 inhalations BID*
2 STRENGTHS FOR PATIENTS WITH ASTHMA 12 YEARS OF AGE AND OLDER1
Previous ICS† dose Recommended starting dosage
Medium to high 160/4.5 mcg 2 inhalations BID*
Low to medium 80/4.5 mcg 2 inhalations BID*
None 160/4.5 mcg or 80/4.5 mcg (depending on asthma severity) 2 inhalations BID*
FOR PEDIATRIC PATIENTS WITH ASTHMA 6 TO LESS THAN 12 YEARS OF AGE
80/4.5 mcg 2 inhalations BID*
SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  • Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus
  • Do not use any additional long-acting beta2-agonists with SYMBICORT for any reason
  • 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. For patients 6 to less than 12 years of age the dosage, is 2 inhalations of SYMBICORT 80/4.5 twice daily. 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
  • Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids
  • *Administered in the morning and the evening.
  • †Inhaled corticosteroid.
  • ‡Pressurized metered-dose inhaler.
  • §The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system.
  • ||Dry powder inhaler.

IMPORTANT SAFETY INFORMATION -

  • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. 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. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone
  • SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
  • SYMBICORT should not be initiated in patients during rapidly deteriorating episodes of asthma or COPD
  • Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason
  • Localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with SYMBICORT. Patients should rinse the mouth after inhalation of SYMBICORT
  • Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS
  • Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients
  • It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS
  • Caution should be exercised when considering administration of SYMBICORT in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors
  • As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT
  • Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm
  • Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  • Long-term use of ICS may result in a decrease in bone mineral density (BMD). Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating SYMBICORT and periodically thereafter
  • ICS may result in a reduction in growth velocity when administered to pediatric patients
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the administration of ICS, including budesonide, a component of SYMBICORT. Close monitoring is warranted in patients with a change in vision or history of increased intraocular pressure, glaucoma, or cataracts
  • In rare cases, patients on ICS may present with systemic eosinophilic conditions
  • SYMBICORT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
  • Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients
  • The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, pharyngitis, rhinitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis
  • The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
  • SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents
  • Beta-blockers may not only block the pulmonary effect of beta-agonists, such as formoterol, but may produce severe bronchospasm in patients with asthma
  • ECG changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. Use caution with the coadministration of SYMBICORT

IMPORTANT SAFETY INFORMATION

  • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids [ICS]) for asthma is associated with an increased risk of asthma-related death. 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. When LABA are used in fixed dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to ICS alone
 +

INDICATIONS

  1. SYMBICORT is indicated for the treatment of asthma in patients 6 years and older not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA. (also see DOSAGE AND ADMINISTRATION).
  2. SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations.
  3. SYMBICORT is NOT indicated for the relief of acute bronchospasm.

Please see full Prescribing Information , including Patient Information.

You may report side effects related to AstraZeneca products .

References:

  1. SYMBICORT [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. Data on File. US-98380. AstraZeneca Pharmaceuticals LP.
  3. Rennard SI, Tashkin DP, McElhattan J, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs. 2009;69(5):549-565.
  4. Data on File, REF-4960, AZPLP.
  5. Noonan M, Rosenwasser LJ, Martin P, O’Brien CD, O’Dowd L. Efficacy and safety of budesonide and formoterol in one pressurised metered-dose inhaler in adults and adolescents with moderate to severe asthma: a randomised clinical trial. Drugs. 2006;66(17):2235-2254.
  6. Data on File, REF-4962, AZPLP.
  1. Pearlman DS, Eckerwall G, McLaren J, et al. Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years). Ann Allergy Asthma Immunol. 2017;118:489-499.
  2. Data on File, REF-12860, AZPLP.
  3. SYMBICORT [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  4. Scichilone N, Benfante A, Bocchino M, et al. Which factors affect the choice of inhaler in chronic obstructive respiratory diseases? Pulm Pharmacol Ther. 2015;31:63-67.
  5. US Department of Health and Human Services. FDA, Combination products. Jurisdictional update: metered dose inhalers, spacers and other accessories. https://www.fda.gov/combination-products/jurisdictional-updates/jurisdictional-update-metered-dose-inhalers-spacers-and-other-accessories. Updated February 12, 2020. Accessed July 31, 2023.
  1. Rennard SI, Tashkin DP, McElhattan J, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered-dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1-year randomized controlled clinical trial. Drugs. 2009;69(5):549-565.
  2. Data on File, REF-4960, AZPLP.
  3. SYMBICORT [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  4. Data on File, REF-16658, AZPLP.
  5. Data on File, REF-5076, AZPLP.
  6. Data on File, REF-5103, AZPLP.
  7. Data on File, REF-61427, AZPLP.
  1. SYMBICORT [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. Data on File, REF-4962, AZPLP.
  3. Noonan M, Rosenwasser LJ, Martin P, O’Brien CD, O’Dowd L. Efficacy and safety of budesonide and formoterol in one pressurised metered-dose inhaler in adults and adolescents with moderate to severe asthma: a randomised clinical trial. Drugs. 2006;66(17):2235-2254.
  4. Data on File, REF-35897, AZPLP.
  5. Kaiser H, Parasuraman B, Boggs R, Miller CJ, Leidy NK, O’Dowd L. Onset of effect of budesonide and formoterol administered via one pressurized metered-dose inhaler in patients with asthma previously treated with inhaled corticosteroids. Ann Allergy Asthma Immunol. 2008;101:295-303.
  6. Data on File, REF-4989, AZPLP.
  7. Data on File, REF-85507, AZPLP.
  8. National Heart, Lung, and Blood Institute. Expert panel report 3: guidelines for the diagnosis and management of asthma—full report 2007. August 28, 2007. https://www.nhlbi.nih.gov/sites/default/files/media/docs/EPR-3_Asthma_Full_Report_2007.pdf. Accessed July 31, 2023.
  1. SYMBICORT [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
  2. US Department of Health and Human Services. FDA, Combination products. Jurisdictional update: metered dose inhalers, spacers and other accessories.https://www.fda.gov/combination-products/jurisdictional-updates/jurisdictional-update-metered-dose-inhalers-spacers-and-other-accessories Updated February 12, 2020. Accessed July 31, 2023. 
  3. Scichilone N, Benfante A, Bocchino M, et al. Which factors affect the choice of the inhaler in chronic obstructive respiratory diseases? Pulm Pharmacol Ther. 2015;31:63-67.