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.

Adult Dosage:

≥12yrs: Initially 2 inh of 100mcg/5mcg or 200mcg/5mcg twice daily (AM & PM), based on disease severity and previous asthma therapy. If inadequate response after 2 weeks, may increase dose for additional control. Max: 800mcg/20mcg daily (2 inh of 200mcg/5mcg twice daily). Rinse mouth after use.

Children Dosage:

<5yrs: not established. 5–<12yrs: 2 inh of 50mcg/5mcg twice daily (AM & PM). Max: 200mcg/20mcg daily.

DULERA Contraindications:

Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.

DULERA Warnings/Precautions:

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.

DULERA Classification:

Corticosteroid + long-acting beta-2 agonist (LABA).

DULERA Interactions:

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.

Adverse Reactions:

Nasopharyngitis, sinusitis, headache; oral candidiasis, hypersensitivity reactions.

Generic Drug Availability:


How Supplied:

Inhaler—13g (120 inh)