ArmonAir RespiClick(Fluticasone Propionate Multidose Dry Powder Inhaler for Oral Inhalation)

ARMONAIR RESPICLICK Rx

Generic Name and Formulations:

Fluticasone propionate 55mcg, 113mcg, 232mcg; per actuation; dry pwd inhaler for oral inh with a dose counter.

Company:

Teva Pharmaceuticals

Indications for ARMONAIR RESPICLICK:

Maintenance treatment of asthma as prophylactic therapy. 

Limitations Of use:

Not for the relief of acute bronchospasm.

Adult:

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 inhaled steroid: 1 inh of 55mcg twice daily; already on inhaled steroid: see full labeling. 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:

<12yrs: not established. 

Contraindications:

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

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. Reeva luate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, or any visual changes. 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. 

Pharmacological Class:

Steroid.

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 Availability:

NO

How Supplied:

RespiClick (60 actuations)—1