Generic Name and Formulations:
Mometasone furoate, formoterol fumarate dihydrate 100mcg/5mcg; per inh; metered-dose inhaler; contains HFA.
Company:
Merck & Co., Inc.
 
Select therapeutic use: Asthma/COPD
Indications for DULERA 100/5:
Maintenance treatment of asthma in patients not adequately controlled on other asthma-controller medications or whose disease severity warrants initiation of both an inhaled steroid and a long acting β2-agonist.

Limitations Of use:
Not for relief of acute bronchospasm.

Adult:
Previously on medium dose of steroid: use 100/5 strength; previously on high dose of steroid: use 200/5 strength. For both: Two inhalations twice daily (AM & PM). Rinse mouth after use.

Children:
Not established.

Contraindications:
Primary treatment of status asthmaticus or acute asthma attacks.

Warnings/Precautions:
Long-acting β2-adrenergic agonist may increase the risk of asthma-related death. Do not exceed recommended dose. Not for use with other long-acting β2-agonists. Transferring from systemic steroids: taper gradually. Do not initiate in significantly or acutely deteriorating asthma. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Aneurysm. Pheochromocytoma. Convulsive disorders. Thyrotoxicosis. Hepatic impairment. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Immunosuppressed. Untreated infections (eg, fungal, bacterial, viral, parasitic), TB, ocular herpes. If exposed to chickenpox or measles, consider anti-infective prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with inhaled corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, lassitude). Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. History of increased intraocular pressure, glaucoma, cataracts; monitor. Monitor potassium, blood glucose; bone mineral density if other osteoporosis risk factors exist; and for growth suppression in children; hypercorticism and HPA axis suppression (if occurs, discontinue gradually). Labor & delivery. Pregnancy. Nursing mothers: not recommended.

Interactions:
Concomitant other long-acting β2-agonists (eg, formoterol, arformoterol, salmeterol): not recommended. Caution with concomitant MAOIs, tricyclic antidepressants, macrolides, drugs that prolong QTc (increased cardiac effects), or within 2 weeks of discontinuing these agents. Caution with other sympathomimetics (except short-acting bronchodilators). Formoterol may be potentiated by concomitant adrenergic agents; caution. Mometasone systemic effects may be potentiated by concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin). Hypokalemia potentiated by xanthines, steroids, K+-depleting diuretics. Antagonized by β-blockers. Increased risk of arrhythmias with concomitant anesthesia with halogenated hydrocarbons.

See Also:
DULERA 200/5

Pharmacological Class:
Steroid + long-acting beta-2 agonist.

Adverse Reactions:
Nasopharyngitis, sinusitis, headache, candidiasis, β2-agonist effects (eg, hypokalemia, hyperglycemia), paradoxical bronchospasm; rarely: serious asthma episode, asthma-related death.

Generic Availability:
NO

How Supplied:
Inhaler—13g (120 inh)