Indications for WIXELA INHUB:
Treatment of asthma in patients 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. For 250mcg/50mcg only: maintenance treatment of COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations.
Limitations of Use:
Not for relief of acute bronchospasm.
Allow approx. 12hrs between doses. Asthma: ≥12yrs: initially 1 inh of 100/50 or 250/50 or 500/50 twice daily, based on disease severity and previous asthma therapy. If insufficient response after 2wks, use next higher strength. Max 1 inh of 500/50 twice daily. COPD: 1 inh of 250/50 twice daily. Rinse mouth after use.
<4yrs: not established. Allow approximately 12hrs between doses. Asthma: 4–11yrs: 1 inh of 100/50 twice daily. Rinse mouth after use.
Primary treatment of status asthmaticus or other acute episodes of asthma or COPD requiring intensive measures. Severe hypersensitivity to milk protein.
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 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, IOP, glaucoma, or cataracts. Consider eye exams if ocular symptoms develop or in long-term use. Discontinue and treat 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, prolonged immobilization, osteoporosis, postmenopausal, advanced age, others). Labor & delivery. Pregnancy: monitor. Nursing mothers.
Corticosteroid + long-acting beta-2 agonist (LABA).
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended. Caution during or within 2 weeks of discontinuing MAOIs or tricyclic antidepressants, β-blockers (consider cardioselective), K+-depleting diuretics.
Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headache, nausea, vomiting, pneumonia, throat irritation, musculoskeletal pain; hypersensitivity reactions, cardiovascular or CNS effects.
Inhaler—1 (60 metered doses)