The usual dosage is the inhalation of the contents of one 12 mcg FORADIL capsule every 12 hours using the AEROLIZER inhaler. A total daily dose of greater than 24 mcg is not recommended. If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of COPD.Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death.
Therefore, when treating patients with asthma, FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including FORADIL AEROLIZER.A 28-week, placebo-controlled US study comparing the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs.
3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34).
The increased risk of asthma-related death may represent a class effect of the long-acting beta2-adrenergic agonists, including formoterol.
No study adequate to determine whether the rate of asthma-related death is increased with FORADIL AEROLIZER has been conducted.Clinical studies with FORADIL AEROLIZER suggested a higher incidence of serious asthma exacerbations in patients who received FORADIL AEROLIZER than in those who received placebo (See ADVERSE REACTIONS).
The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.The studies described above enrolled patients with asthma.
No studies have been conducted that were adequate to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists.FORADIL AEROLIZER should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition.
The use of FORADIL AEROLIZER in this setting is inappropriate.FORADIL AEROLIZER should not be used in conjunction with an inhaled, long-acting beta2-agonist.
FORADIL AEROLIZER should not be used with other medications containing long-acting beta2-agonists.FORADIL AEROLIZER is not a substitute for inhaled or oral corticosteroids.
Corticosteroids should not be stopped or reduced at the time FORADIL AEROLIZER is initiated.
When beginning treatment with FORADIL AEROLIZER, patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute asthma symptoms.See PRECAUTIONS, Information for Patients and the accompanying Medication Guide.