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DULERA 100/5

Last Updated: August 05, 2010

Manufacturer:

Merck & Co., Inc.

Pharmacological Class:

Antiasthmatic (steroid + long-acting β₂-agonist)

Active Ingredient(s):

Mometasone furoate 100mcg, formoterol fumarate dihydrate 5mcg; per inh; metered-dose inhaler; contains HFA.

Also:

DULERA 200/5
Mometasone furoate 200mcg, formoterol fumarate dihydrate 5mcg; per inh; metered-dose inhaler; contains HFA.

Indication(s):

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.

Pharmacology:

Dulera is an oral metered-dose inhaler that combines the anti-inflammatory agent, mometasone furoate, and the long-acting β₂-agonist, formoterol fumarate, for the maintenance treatment of asthma. Mometasone is a synthetic corticosteroid with potent antiinflammatory activity. Inhaled formoterol acts in the lung as a bronchodilator; due to the presence of β₂-agonist receptors in the heart, it has cardiac effects as well.

Clinical Trials:

Two randomized, double-blind, parallel-group studies in patients with persistent asthma that was uncontrolled on medium or high dose inhaled steroids were conducted to demonstrate the safety and efficacy of Dulera. In both studies, Dulera demonstrated significantly higher increases from baseline in FEV1 AUC at week 12 compared to mometasone furoate alone.

Legal Classification:

Adults:

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 recommended.

Contraindication(s):

Not for 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 (especially coronary insufficiency, arrhythmias, hypertension). Hyperthyroidism. Convulsive disorders. Hepatic impairment. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Immunosuppressed. Untreated infections, 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. Monitor potassium, intraocular pressure; 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. Do not use with spacers. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interaction(s):

Concomitant other long-acting β₂-agonists (eg, formoterol, arformoterol, salmeterol): not recommended. Avoid within 2 weeks of MAOIs, tricyclic antidepressants, drugs that prolong QTc (increased cardiac effects). Caution with other sympathomimetics (except short-acting bronchodilators). Mometasone systemic effects may be potentiated by concomitant potent CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Hypokalemia potentiated by xanthines, steroids, K⁺-depleting diuretics. Antagonized by β-blockers.

Adverse Reaction(s):

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