SYMBICORT 80/4.5 Rx
Generic Name and Formulations:
Budesonide 80mcg, formoterol fumarate dihydrate 4.5mcg; per inh; pressurized metered-dose inhaler.
Indications for SYMBICORT 80/4.5:
Treatment of asthma in patients ≥6yrs old not adequately controlled on a long-term asthma control medication [eg, inhaled corticosteroid (ICS)] or whose disease warrants initiation of both an ICS and LABA.
Limitations Of use:
Not for relief of acute bronchospasm.
Allow approx.12hrs between doses. Asthma: Base initial dose on asthma severity. 2 inh of 80/4.5 or 160/4.5 twice daily (AM & PM). If insufficient response after 1–2 weeks using 80/4.5 strength, may switch to 160/4.5 strength. Max 2 inh of 160/4.5 twice daily. Titrate to lowest effective strength after adequate response. COPD: 2 inh of 160/4.5 twice daily. Rinse mouth after use.
Allow approx. 12hrs between doses. Asthma: <6yrs: not established. 6–<12yrs: 2 inh of 80/4.5 twice daily (AM & PM). Rinse mouth after use. COPD: not indicated.
Primary treatment of status asthmaticus or acute attacks of asthma or COPD requiring intensive measures.
LABA monotherapy (without ICS) may increase risk of asthma-related events (death, hospitalizations, intubations). Do not initiate in rapidly or acutely deteriorating COPD or asthma. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin prophylaxis or antiviral treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress, a severe COPD exacerbation, or a severe asthma attack. May unmask previously suppressed allergic conditions. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Eosinophilic conditions. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, osteoporosis, postmenopausal). Labor & delivery. Pregnancy. Nursing mothers.
Corticosteroid + long-acting beta-2 agonist (LABA).
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin), during or within 2 weeks of discontinuing MAOIs or tricyclic antidepressants, β-blockers (consider cardioselective), K+-depleting diuretics.
Nasopharyngitis, pharyngolaryngeal pain, sinusitis, nasal congestion, oral candidiasis, headache, upper respiratory infection, flu, back pain, stomach discomfort, vomiting; hypersensitivity reactions. COPD: also bronchitis.
Inhaler—10.2g (120 inh)