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DULERA 100/5
Asthma/COPD
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Drug Name:

DULERA 100/5 Rx

DULERA (mometasone furoate/formoterol fumarate dihydrate) metered-dose inhaler by Merck & Co.

Generic Name and Formulations:
Mometasone furoate 100mcg, formoterol fumarate dihydrate 5mcg; per inh; metered-dose inhaler; contains HFA.

Company:
Merck & Co., Inc.

e-Prescribe this drug via Surescripts

Therapeutic Use:

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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.

Adult Dose for DULERA 100/5:

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's Dose for DULERA 100/5:

Not recommended.

See Also:

DULERA 200/5

Pharmacological Class:

Steroid + long-acting beta-2 agonist.

Contraindications:

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.

Interactions:

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 Reactions:

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

How Supplied:

Inhaler—13g (120 inh)