Selective beta2-adrenergic agonist - ATC code: R03AC13

formoterol fumarate dihydrate

One capsule contains 12 micrograms formoterol fumarate dihydrate. 25 mg of lactose per capsule.

Inhalation powder in capsules.

Foradil is indicated in asthma (including nocturnal asthma and exercise-induced symptoms) for those treated with inhaled corticosteroids who also require a long-acting beta agonist in accordance with current treatment guidelines.

Foradil is indicated for the relief of reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD) requiring long-term bronchodilatory therapy.

For use in adults (including the elderly) and in children 5 years of age and older

Foradil inhalation powder capsules should be used only with the inhaler device provided in the Foradil pack. There is no safety or efficacy data on the use of Foradil inhalation powder capsules with other marketed inhalation devices.

Adults (including the elderly)

Asthma

Foradil should only be prescribed as an add-on to an inhaled corticosteroid.

Regular maintenance therapy: 1 inhalation capsule (equivalent to 12 micrograms formoterol) to be inhaled twice daily. For more severe cases 2 inhalation capsules to be inhaled twice daily. This dosing regimen provides symptomatic relief throughout day and night. The recommended maximum daily dose is 48 micrograms per day.

Foradil should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used.

Chronic Obstructive Pulmonary Disease

For regular maintenance therapy, 1 inhalation capsule (equivalent to 12 micrograms formoterol) to be inhaled twice daily.

Renal and hepatic impairment

There is no theoretical reason to suggest that Foradil dosage requires adjustment in patients with renal or hepatic impairment, however no clinical data have been generated to support its use in these groups.

Children aged 5 and above

Asthma

Foradil should only be prescribed as an add-on to an inhaled corticosteroid.

For regular maintenance therapy: 1 inhalation capsule (equivalent to 12 micrograms formoterol) to be inhaled twice daily.

The recommended maximum daily dose is 24 micrograms per day.

For children 5-12 years of age, when treatment with an inhaled corticosteroid and long-acting beta2-agonist (LABA) is required, it is recommended to use a combination product, except in cases where separate inhaled corticosteroid and long-acting beta2-agonist inhalers are more appropriate.

Foradil should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used.

Foradil should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used.

Chronic Obstructive Pulmonary Disease

Not appropriate

Children under 5 years

Foradil is not recommended in children under the age of 5 years

See adults

Known hypersensitivity to formoterol or to any of the excipients.

Formoterol, the active ingredient of Foradil, belongs to the class of long-acting beta2-adrenergic agonists (LABAs). In a study with salmeterol, a different long-acting beta2-agonist, a higher rate of death due to asthma was observed in the patients treated with salmeterol (13/13,176) than in the placebo group (3/13,179). No study adequate to determine whether the rate of asthma-related death is increased with Foradil has been conducted.

In the treatment of asthma

Foradil should not be used (and is not sufficient) as the first treatment for asthma.

When treating patients with asthma, use Foradil, only as an add-on to an inhaled corticosteroid (ICS) for patients who are not adequately controlled on an ICS alone or whose disease severity clearly warrants initiation of treatment with both an ICS and a LABA.

For children 5-12 years of age, when treatment with an ICS and LABA is required, it is recommended to use a combination product, except in cases where a separate ICS and LABA are more appropriate.

Foradil should not be used in conjunction with another LABA

Whenever Foradil is prescribed, patients should be evaluated for the adequacy of the anti-inflammatory therapy they receive. Patients must be advised to continue taking anti-inflammatory therapy unchanged after the introduction of Foradil, even when their symptoms improve.

The daily dose of Foradil should not be increased beyond the maximum recommended dose.

Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Foradil. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Foradil should be used.

Clinical studies with Foradil suggested a higher incidence of serious asthma exacerbations in patients who received Foradil than in those who received placebo, particularly in patients 5-12 years of age. These studies do not allow precise quantification of the differences in serious asthma exacerbation rates between treatment groups.

Patients should be advised that if, after initiation of Foradil, their symptoms persist, or if the number of doses of Foradil required to control their symptoms increases, this usually indicates a worsening of the underlying condition. In these circumstances, they should be advised to continue treatment but to seek medical advice as soon as possible.

Patients should not be initiated on Foradil or the dose increased during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

Foradil must not be used to relieve acute asthma symptoms. In the event of an acute attack, a short-acting beta2-agonist should be used. Patients must be informed of the need to seek medical treatment immediately if their asthma deteriorates suddenly.

Concomitant conditions

Special care and supervision, with particular emphasis on dosage limits, is required in patients receiving Foradil when the following conditions may exist:

Ischaemic heart disease, cardiac arrhythmias, especially third degree atrioventricular block, severe cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, known or suspected prolongation of the QT interval.

Caution should be used when co-administering theophylline and formoterol in patients with pre-existing cardiac conditions

Due to the hyperglycaemic effect of β2-stimulants, including Foradil, additional blood glucose controls are recommended in diabetic patients.

Hypokalaemia

Potentially serious hypokalaemia may result from β2-agonist therapy, including Foradil. Particular caution is advised in severe asthma as this effect may be potentiated by hypoxia and concomitant treatment. It is recommended that serum potassium levels be monitored in such situations.

Paradoxical bronchospasm

As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy substituted.

Contains lactose (25 mg per inhalation). This amount does not normally cause problems in lactose intolerant patients.

There are no clinical data to support the advice given below, but from consideration of first principles one might expect the following interactions:

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.

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

Administration of Foradil to patients being treated with monoamine oxidase inhibitors, macrolides or tricyclic antidepressants should be performed with caution, since the action of ß2-adrenergic stimulants on the cardiovascular system may be potentiated.

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of ß2-agonists. Hypokalaemia may increase susceptibility to cardiac arrhythmias (for example, in patients treated with digitalis).

There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

The bronchodilating effects of formoterol can be enhanced by anticholinergic drugs.

β-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.

Adverse reactions (Table 1) are ranked in descending order of frequency, as follows: very common ( 1/10); common ( 1/100, < 1/10); uncommon ( 1/1,000, < 1/100); rare ( 1/10,000, <1/1,000); very rare (< 1/10,000); unknown (frequency cannot be estimated from available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Table 1

*The percent of patients with serious asthma exacerbations in clinical studies was higher for Foradil than for placebo and the biggest numerical imbalance was observed in children 5-12 years old.

** These adverse events were reported in patients treated with Foradil during the post-marketing experience.

Novartis Pharmaceuticals UK Ltd

(POM)

15 February 2012