Asmanex Hfa

2.1 General

ASMANEX HFA should be administered only by the orally inhaled route [see Instructions for Use in the Patient Information leaflet]. After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.

The cap from the mouthpiece of the actuator should be removed before using ASMANEX HFA.

ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.

2.2 Dosing

ASMANEX HFA should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route.

Shake well prior to each inhalation.

The recommended doses for ASMANEX HFA treatment based on prior asthma therapy are provided in Table 1.

TABLE 1: Recommended Dosages for ASMANEX HFA Treatment Previous Therapy Recommended Dose * For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be weaned slowly, beginning after at least 1 week of ASMANEX HFA therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.4)]. Inhaled medium-dose corticosteroids ASMANEX HFA 100 mcg,
2 inhalations twice daily Inhaled high-dose corticosteroids ASMANEX HFA 200 mcg,
2 inhalations twice daily Oral corticosteroids* ASMANEX HFA 200 mcg,
2 inhalations twice daily

If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids, should be considered.

The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day). If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.