SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

  • Use of long-acting beta2-adrenergic agonists (LABA) as monotherapy (with out inhaled corticosteroids [ICS]) for bronchial asthma is related to an elevated danger of asthma-related dying. Accessible information from managed medical trials additionally counsel that use of LABA as monotherapy will increase the danger of asthma-related hospitalization in pediatric and adolescent sufferers. These findings are thought-about a category impact of LABA. When LABA are utilized in fastened dose mixture with ICS, information from giant medical trials don’t present a major enhance within the danger of great asthma-related occasions (hospitalizations, intubations, dying) in comparison with ICS alone
  • SYMBICORT is NOT a rescue treatment and does NOT change fast-acting inhalers to deal with acute signs
  • SYMBICORT shouldn’t be initiated in sufferers throughout quickly deteriorating episodes of bronchial asthma or COPD
  • Sufferers who’re receiving SYMBICORT mustn’t use extra formoterol or different LABA for any cause
  • Localized infections of the mouth and pharynx with Candida albicans has occurred in sufferers handled with SYMBICORT. Sufferers ought to rinse the mouth after inhalation of SYMBICORT
  • Decrease respiratory tract infections, together with pneumonia, have been reported following the administration of ICS
  • As a result of attainable immunosuppression, potential worsening of infections may happen. A extra severe and even deadly course of chickenpox or measles can happen in vulnerable sufferers
  • It’s attainable that systemic corticosteroid results corresponding to hypercorticism and adrenal suppression could happen, significantly at greater doses. Specific care is required for sufferers who’re transferred from systemically lively corticosteroids to ICS. Deaths because of adrenal insufficiency have occurred in asthmatic sufferers throughout and after switch from systemic corticosteroids to much less systemically accessible ICS
  • Warning ought to be exercised when contemplating administration of SYMBICORT in sufferers on long-term ketoconazole and different recognized potent CYP3A4 inhibitors
  • As with different inhaled drugs, paradoxical bronchospasm could happen with SYMBICORT
  • Speedy hypersensitivity reactions could happen, as demonstrated by circumstances of urticaria, angioedema, rash, and bronchospasm
  • Extreme beta-adrenergic stimulation has been related to central nervous system and cardiovascular results. SYMBICORT ought to be used with warning in sufferers with cardiovascular problems, particularly coronary insufficiency, cardiac arrhythmias, and hypertension
  • Lengthy-term use of ICS could end in a lower in bone mineral density (BMD). Since sufferers with COPD usually have a number of danger components for diminished BMD, evaluation of BMD is really helpful previous to initiating SYMBICORT and periodically thereafter
  • ICS could end in a discount in progress velocity when administered to pediatric sufferers
  • Glaucoma, elevated intraocular strain, and cataracts have been reported following the administration of ICS, together with budesonide, a element of SYMBICORT. Shut monitoring is warranted in sufferers with a change in imaginative and prescient or historical past of elevated intraocular strain, glaucoma, or cataracts
  • In uncommon circumstances, sufferers on ICS could current with systemic eosinophilic situations
  • SYMBICORT ought to be used with warning in sufferers with convulsive problems, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in sufferers who’re unusually conscious of sympathomimetic amines
  • Beta-adrenergic agonist drugs could produce hypokalemia and hyperglycemia in some sufferers
  • The most typical opposed reactions ≥3% reported in bronchial asthma medical trials included nasopharyngitis, headache, higher respiratory tract an infection, pharyngolaryngeal ache, sinusitis, pharyngitis, rhinitis, influenza, again ache, nasal congestion, abdomen discomfort, vomiting, and oral candidiasis
  • The most typical opposed reactions ≥3% reported in COPD medical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and higher respiratory tract an infection
  • SYMBICORT ought to be administered with warning to sufferers being handled with MAO inhibitors or tricyclic antidepressants, or inside 2 weeks of discontinuation of such brokers
  • Beta-blockers could not solely block the pulmonary impact of beta-agonists, corresponding to formoterol, however could produce extreme bronchospasm in sufferers with bronchial asthma
  • ECG modifications and/or hypokalemia related to nonpotassium-sparing diuretics could worsen with concomitant beta-agonists. Use warning with the coadministration of SYMBICORT

INDICATIONS

  • SYMBICORT is indicated for the remedy of bronchial asthma in sufferers 6 years and older not adequately managed on a long-term asthma-control treatment corresponding to an ICS or whose illness warrants initiation of remedy with each an ICS and LABA (additionally see DOSAGE AND ADMINISTRATION).
  • SYMBICORT 160/4.5 is indicated for the upkeep remedy of airflow obstruction in sufferers with power obstructive pulmonary illness (COPD), together with power bronchitis and/or emphysema, and to scale back COPD exacerbations.
  • SYMBICORT is NOT indicated for the aid of acute bronchospasm.

Please see full Prescribing Info , together with Affected person Info.

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