Indications for AIRDUO DIGIHALER:
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 the relief of acute bronchospasm.
Allow approx. 12hrs between doses. Take at same time each day. Not previously on ICS: initially 1 inh of 55/14mcg twice daily. Switching from an ICS or combination product: 1 inh of 55/14mcg or 113/14mcg or 232/14mcg twice daily, based on disease severity and previous asthma therapy. If insufficient response after 2wks, use next higher strength. Max 1 inh of 232/14mcg twice daily. Titrate to lowest effective dose after stability achieved. Rinse mouth after use.
<12yrs: not established.
AIRDUO DIGIHALER Contraindications:
Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Severe milk protein hypersensitivity.
AIRDUO DIGIHALER 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 signs/symptoms of adrenal insufficiency when transferring from systemic steroids. May need supplemental systemic corticosteroids during periods of stress or a 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). Eosinophilic conditions. Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Hepatic impairment: monitor. 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]). Do not use with spacers. Pregnancy. Nursing mothers.
AIRDUO DIGIHALER Classification:
Corticosteroid + long-acting beta-2 agonist (LABA).
AIRDUO DIGIHALER Interactions:
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended. Caution during or within 2 weeks of discontinuing MAOIs or tricyclic antidepressants, β-blockers (consider cardioselective), K+-depleting diuretics.
Nasopharyngitis, oral candidiasis, back pain, headache, cough; hypersensitivity reactions.
Generic Drug Availability:
RespiClick (60 actuations)—1; Digihaler (60 actuations)—1