Formoterol Fumarate

Short-Acting ß₂-agonists: Aerosol bronchodilators of the short-acting adrenergic stimulant type may be used for relief of breakthrough symptoms while using formoterol. However, increasing use of such preparations to control symptoms indicates deterioration of asthma control and the need to reassess the patientís therapy.

Concomitant administration of other sympathomimetic agents may potentiate the undesirable effects of FORADIL.

Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: FORADIL should be administered with extreme caution in patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants because the action of formoterol on the cardiovascular system may be potentiated by these agents.

Corticosteroids, Methylxanthines and Diuretics: Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalemic effect of ß₂-agonists. Hypokalemia may increase susceptibility to cardiac arrhythmias in patients treated with digitalis.

ß-adrenergic Blockers: ß-adrenergic blockers may weaken or antagonise the effect of FORADIL. Therefore FORADIL should not be given together with ß-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.

Other Drugs:Drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, and tricyclic antidepressants may be associated with QT-interval prolongation and an increased risk of ventricular arrhythmia.

INFORMATION TO BE PROVIDED TO THE PATIENT OR GUARDIAN

See illustrated Information For The Patient or Guardian section. It is important that patients understand how to use FORADIL® (formoterol fumarate) capsules with the supplied Aerolizer^TM inhalation device and how it should be used in relation to other asthma or COPD medications they are taking. Patients/Guardians should be given the following information:

i. The recommended dosage (one or two capsules twice daily, morning and evening) should not be exceeded.

ii. FORADIL is not meant to relieve acute asthma or COPD symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with a short-acting, inhaled ß₂ -agonist such as salbutamol (the physician should provide the patient with such medication and instruct the patient in how it should be used).

iii. The physician should be notified immediately if any of the following situations occur, which may be a sign of seriously worsening asthma:

ï Decreased effectiveness of short-acting, inhaled ß₂- agonists;

ï Need for more inhalations than usual of short-acting, inhaled ß₂ -agonists.

iv. FORADIL should not be used as a substitute for oral or inhaled corticosteroids. The dosage of these medications should not be changed and they should not be stopped without consulting the physician, even if the patient feels better after initiating treatment with FORADIL.

v. Patients should be cautioned regarding potential adverse cardiovascular effects, such as palpitations or chest pain.

vi. In patients receiving FORADIL, other inhaled medications should be used only as directed by the physician.

vii. Guardians of children who have been prescribed FORADIL should be alerted to the general concern regarding asthma therapy compliance, especially neglect of anti-inflammatory therapy and overuse of short-acting ß₂-agonists.