Antiasthmatic (corticosteroid + long-acting β2-agonist)
Budesonide 160 µg, formoterol fumarate dihydrate 4.5 µg; per inh; pressurized metered-dose inhaler.
Budesonide 80 µg, formoterol fumarate dihydrate 4.5 µg; per inh; pressurized metered-dose inhaler.
Long-term maintenance treatment of asthma in patients ≥ 12 years old not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or those whose disease severity clearly warrants starting treatment with two maintenance therapies.
Symbicort combines the anti-inflammatory agent, budesonide, with the long-acting selective β2-agonist, formoterol, in a single metered-dose oral inhaler.
Improvements in efficacy end points (e.g., 12-hour-average post-dose FEV1 at Week 2, and pre-dose FEV1 over the course of the study) were greater with Symbicort than with budesonide or formoterol given alone. Significant improvement in FEV1 occurred within 15 minutes of beginning therapy with Symbicort. Improvement in asthma control occurred within one day.
Not adequately controlled on low- to medium-dose inhaled steroids: start with 80/4.5 strength. Not adequately controlled on medium- to high-dose inhaled steroids: start with 160/4.5 strength. If not on inhaled steroids: choose strength depending on asthma severity. If insufficient response after one to two weeks using 80/4.5 strength, may switch to 160/4.5 strength. For all: two inhalations twice daily (am & pm). Rinse mouth after use.
Not established (see literature). Contraindications: Not for acute relief of bronchospasm. Do not initiate in significantly or acutely deteriorating asthma.
Re-evaluate periodically. Do not exceed recommended dose. Not for use with other long-acting β2-agonists or for transferring from oral steroids.
Cardiovascular disease (especially coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Hypokalemia. Severe hepatic impairment. Hyperresponsiveness to sympathomimetics. Diabetes. Hyperthyroidism. Ketoacidosis. Immunosuppressed. Tuberculosis.
Untreated infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider anti-infective prophylactic therapies. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with inhaled corticosteroids may exacerbate symptoms of adrenal insufficiency (e.g., lassitude). Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Monitor potassium, intraocular pressure, bone mineral density if other osteoporosis risk factors exist; and for growth suppression in adolescents; hypercorticism and HPA axis suppression. Pregnancy (Cat. C). Labor & delivery. Nursing mothers.
Caution with MAOIs, tricyclic antidepressants, beta blockers, K+-depleting diuretics, long-term ketoconazole, other potent CYP3A4 inhibitors.
Nasopharyngitis, pharyngolaryngeal pain, sinusitis, congestion, oral candidiasis, headache, upper respiratory infection, flu, back pain, GI upset; rarely: paradoxical bronchospasm, hypersensitivity reactions; severe asthma episodes; increased risk of asthma-related death.
Inhaler—10.2 g (120 inhalations)
For more information, visit www.Symbicort.com.