Long-term maintenance treatment of asthma in patients ≥12yrs old not adequately controlled on other asthma-controller medications (eg, low-medium dose inhaled corticosteroids) or those whose disease severity clearly warrants starting treatment with two maintenance therapies.
Allow approximately 12 hours 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.
Not established (see literature).
Corticosteroid + long-acting beta-2 agonist.
Not for primary treatment of acute attacks of asthma or COPD where intensive measures required.
Increased risk of asthma-related deaths and hospitalizations. Reevaluate periodically. Do not exceed recommended dose. Not for use with other long-acting β2-agonists or for transferring from oral steroids. Do not initiate in rapidly or acutely deteriorating asthma or COPD. Not for relief of acute bronchospasm. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Hepatic impairment (monitor). Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Immunosuppressed. Eosinophilic conditions. Tuberculosis. COPD: monitor for pneumonia. Untreated infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with inhaled corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, 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: not recommended.
Caution with long-term ketoconazole and other potent CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin), during and within 2 weeks of MAOIs and tricyclic antidepressants; β-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 (discontinue if occurs), hypersensitivity reactions; severe asthma episodes; increased risk of asthma-related death. COPD: bronchitis.
Inhaler—10.2g (120 inh)