Generic Name and Formulations:
Fluticasone propionate, salmeterol (as xinafoate) 55mcg/14mcg, 113mcg/14mcg, 232mcg/14mcg; per actuation; dry pwd for oral inh with a dose counter.
Treatment of asthma.
Not for the relief of acute bronchospasm.
Allow approx. 12hrs between doses. Take at same time each day. Rinse mouth after each dose. Not previously on inhaled steroid: 1 inh of 55/14mcg twice daily; already on inhaled steroid: see full labeling. If insufficient response after 2wks, use next higher strength. Max 1 inh of 232/14mcg twice daily. Titrate to lowest effective dose after stability achieved.
<12yrs: not established.
Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Severe milk protein hypersensitivity.
Increased risk of asthma-related deaths and hospitalizations. Do not initiate in rapidly or acutely deteriorating 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. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for signs/symptoms of 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, visual changes, or with a history of increased intraocular pressure, glaucoma, and/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, prolonged immobilization, osteoporosis, or chronic use of drugs that can reduce bone mass [eg, anticonvulsants, oral steroids]). Do not use with spacers. Pregnancy: monitor closely. Nursing mothers.
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended. Caution with other sympathomimetics (except short-acting bronchodilators), during or within 2 weeks of MAOIs, tricyclic antidepressants, K+–depleting diuretics. Antagonized by β-blockers; avoid if no alternatives, consider cardio-selective β-blockers.
Steroid + long-acting beta-2 agonist.
Nasopharyngitis, oral candidiasis, back pain, headache, cough; hypersensitivity reactions; rarely: serious asthma episode, asthma-related death.
RespiClick (60 actuations)—1
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