ARMONAIR DIGIHALER - Pulmonology Advisor

ARMONAIR DIGIHALER Rx

Asthma/COPD:

Indications for ARMONAIR DIGIHALER:

Maintenance treatment of asthma as prophylactic therapy.

Limitations of Use:

Not for the relief of acute bronchospasm.

Adult Dosage:

Administer 1 inhalation twice daily (approx. 12hrs apart) by orally inhaled route. Take at same time each day. Rinse mouth after each dose. Not previously on ICS: initially 1 inh of 55mcg twice daily. For greater severity (use higher strengths): either 113mcg or 232mcg given twice daily. Switching from another ICS: use the low (55mcg), medium (113mcg), or high (232mcg) dose strength, based on disease severity and the strength of previous ICS product. If insufficient response after 2 weeks, increasing the dose may provide additional asthma control. Max 1 inh of 232mcg twice daily. Titrate to lowest effective dose after stability achieved. Do not use with spacers or volume holding chambers.

Children Dosage:

<12yrs: not established.

ARMONAIR DIGIHALER Contraindications:

Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Severe milk protein hypersensitivity.

ARMONAIR DIGIHALER Warnings/Precautions:

Do not exceed recommended dose. Risk of local infections (eg, mouth/pharynx candidiasis). Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Immunosuppression: active or quiescent tuberculosis, systemic infections, ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for signs/symptoms of adrenal insufficiency when transferring from systemic corticosteroids. 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, change in vision or with history of increased intraocular pressure, glaucoma, and/or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Eosinophilic conditions. 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]). Pregnancy: monitor closely. Nursing mothers.

ARMONAIR DIGIHALER Classification:

Steroid.

ARMONAIR DIGIHALER Interactions:

Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended.

Adverse Reactions:

Nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache, cough; hypersensitivity reactions, adrenal suppression, immunosuppression, Churg-Strauss syndrome, bronchospasm.

Generic Drug Availability:

NO

How Supplied:

Digihaler (60 actuations)—1

ARMONAIR DIGIHALER Rx

Asthma/COPD:

Indications for ARMONAIR DIGIHALER:

Maintenance treatment of asthma as prophylactic therapy.

Limitations of Use:

Not for the relief of acute bronchospasm.

Adult Dosage:

Administer 1 inhalation twice daily (approx. 12hrs apart) by orally inhaled route. Take at same time each day. Rinse mouth after each dose. Not previously on ICS: initially 1 inh of 55mcg twice daily. For greater severity (use higher strengths): either 113mcg or 232mcg given twice daily. Switching from another ICS: select the low (55mcg), medium (113mcg), or high (232mcg) dose strength, based on disease severity and the strength of previous ICS product. If insufficient response after 2 weeks, increasing the dose may provide additional asthma control. Max 1 inh of 232mcg twice daily. Titrate to lowest effective dose after stability achieved. Do not use with spacers or volume holding chambers.

Children Dosage:

<12yrs: not established.

ARMONAIR DIGIHALER Contraindications:

Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Severe milk protein hypersensitivity.

ARMONAIR DIGIHALER Warnings/Precautions:

Do not exceed recommended dose. Risk of local infections (eg, mouth/pharynx candidiasis). Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Immunosuppression: active or quiescent tuberculosis, systemic infections, ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for signs/symptoms of adrenal insufficiency when transferring from systemic corticosteroids. 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, change in vision or with history of increased intraocular pressure, glaucoma, and/or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Eosinophilic conditions. 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]). Pregnancy: monitor closely. Nursing mothers.

ARMONAIR DIGIHALER Classification:

Steroid.

ARMONAIR DIGIHALER Interactions:

Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): not recommended.

Adverse Reactions:

Nasopharyngitis, upper respiratory tract infection, oral candidiasis, headache, cough; hypersensitivity reactions, adrenal suppression, immunosuppression, Churg-Strauss syndrome, bronchospasm.

Generic Drug Availability:

NO

How Supplied:

Digihaler (60 actuations)—1