Generic Name and Formulations:
Mometasone furoate, formoterol fumarate dihydrate 100mcg/5mcg, 200mcg/5mcg; per inh; metered-dose inhaler; contains HFA.
Merck & Co., Inc.
Indications for DULERA:
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.
Limitations Of use:
Not for relief of acute bronchospasm.
Initially 2 inh of 100mcg/5mcg or 200mcg/5mcg twice daily (AM & PM), based on disease severity and previous asthma therapy. Max 2 inh of 200mcg/5mcg twice daily (max 800mcg/20mcg per day). Rinse mouth after use.
<12yrs: not established.
Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
Increased risk of asthma-related events (death, hospitalizations, intubations) with LABA monotherapy (without ICS). 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 prophylaxis or antiviral treatment. Monitor for adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress or 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). Aneurysm. Pheochromocytoma. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Hepatic impairment. 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]). Labor & delivery. Pregnancy. Nursing mothers.
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin), during or within 2 weeks of discontinuing MAOIs, tricyclic antidepressants, macrolides, or drugs known to prolong QT interval (increased cardiac effects), adrenergic agents, β-blockers (consider cardioselective), K+-depleting diuretics. Hypokalemia potentiated by xanthine derivatives. Increased risk of arrhythmias with concomitant anesthesia with halogenated hydrocarbons.
Corticosteroid + long-acting beta-2 agonist (LABA).
Nasopharyngitis, sinusitis, headache; oral candidiasis, hypersensitivity reactions.
Inhaler—13g (120 inh)