Foradil

/ Novartis

Method of administration: For inhalation use in adults and in children 6 years of age and older. Foradil capsules for inhalation should be used only with the Aerolizer inhaler provided in the Foradil pack. To ensure proper administration of the drug, a physician or other health professional should:
– Show the patient how to use the inhaler.
– Dispense the capsule only together with the inhaler.
– Instruct the patient that the capsules are only for inhalation use and not to be swallowed. Detailed handling instructions are included in the package leaflet. It is important for the patient to understand that the gelatin capsule might fragment and small pieces of gelatin might reach the mouth or throat after inhalation. The tendency for this to happen is minimised by not piercing the capsule more than once. The capsule made of edible gelatin is not harmful if ingested. The capsules should be removed from the blister pack only immediately before use.
Adults
Asthma: For regular maintenance therapy, 1 to 2 inhalation capsules (equivalent to 12 to 24 micrograms formoterol) twice daily. Foradil should only be prescribed as an add-on to an inhaled corticosteroid (ICS). The maximum recommended maintenance dose is 48 micrograms per day. If required, an additional 1 to 2 capsules per day may be used for the relief of ordinary symptoms provided the recommended daily maximum dose of 48 micrograms per day is not exceeded. However, if the need for additional doses is more than occasional (e.g. more frequent than 2 days per week) medical advice should be sought and therapy reassessed, as this may indicate a worsening of the underlying condition. 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.
Prophylaxis against exercise-induced bronchospasm: The content of 1 inhalation capsule (12 microgram) should be inhaled at least 15 minutes prior to exercise. In patients with a history of severe bronchospasm, 2 inhalation capsules (24 microgram) may be necessary as prophylaxis. In patients with persistent asthma, use of Foradil for the prevention of exercise-induced bronchospasm may be clinically indicated, but the treatment of asthma should also include an ICS.
Chronic obstructive pulmonary disease: For regular maintenance therapy, 1 inhalation capsule (12 micrograms) to be inhaled twice daily.
Pediatrics (Children aged 6 years or older)
Asthma: For regular maintenance therapy, 1 inhalation capsule (12 microgram) twice daily. Foradil should only be prescribed as an add-on to an inhaled corticosteroid. For children 6-12 years of age, treatment with a combination product containing an inhaled corticosteroid and long-acting beta2-agonist (LABA) is recommended, except in cases where a separate inhaled corticosteroid and long-acting beta2-agonist are required. The maximum recommended dose is 24 microgram per day. Although Foradil has a rapid onset of action, current asthma management guidelines recommend that long-acting inhaled bronchodilators should be used for maintenance bronchodilator therapy. They further recommend that in the event of an acute attack, a beta agonist with a short duration of action should be used. In accordance with the current management guidelines, long-acting beta 2-agonists may be added to the treatment regimen in patients experiencing problems with high dose inhaled steroids. Alternatively, where regular symptomatic treatment of asthma is required in addition to inhaled steroids, then long-acting beta 2-agonists can be used. Patients should be advised not to stop or change their steroid therapy when Foradil is introduced. If the symptoms persist or worsen, or if the recommended dose of Foradil fails to control symptoms (maintain effective relief), this is usually an indication of a worsening of the underlying condition.
Prophylaxis against exercise-induced bronchospasm: The content of 1 inhalation capsule (12 micrograms) should be inhaled at least 15 minutes prior to exercise. In patients with persistent asthma, use of Foradil for the prevention of exercise-induced bronchospasm may be clinically indicated, but the treatment of asthma should also include an ICS. Foradil is not recommended in children under 6 years of age.
Adults and children aged 6 years or older: The bronchodilator effect of Foradil is still significant 12 hours after inhalation. Therefore, in most cases, twice-daily maintenance therapy will control the bronchoconstriction associated with chronic conditions, both during the day and at night.
Special populations
Renal impairment: Formoterol has not been studied in patients with renal impairment.
Hepatic impairment: Formoterol has not been studied in patients with hepatic impairment.
Geriatrics (older than 65 years): The pharmacokinetics of formoterol has not been studies in the elderly population. The available data from clinical trials performed in elderly patients do not suggest that the dosage should be different than in other adults.
For full details see prescribing information.

Foradil is indicated in asthma (including nocturnal asthma and exercise-induced symptoms) in those treated with inhaled corticosteroids who also require a long-acting beta agonist in accordance with current treatment guidelines. Prophylaxis and treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Hypersensitivity to any ingredients of the preparation.

In the treatment of asthma: Foradil should not be used (and is not sufficient) as the first treatment for asthma. Asthmatic patients who require regular therapy with a beta 2-agonist should also receive regular and adequate doses of an inhaled anti-inflammatory agent (e.g. corticosteroids, and/or sodium cromoglicate) or oral corticosteroids. 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. Should symptoms persist, or should the number of doses of Foradil required to control symptoms increase, this usually indicates a worsening of the underlying condition and warrants a reassessment of asthma therapy by a physician. Although Foradil may be introduced as add-on therapy when inhaled anti-inflammatory agents (e.g. corticosteroids) do not provide adequate control of asthma symptoms, patients should not be initiated on Foradil during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Serious asthma-related adverse events and exacerbations may occur during treatment with Foradil. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled, or worsen, after initiation on Foradil.
Asthma-related death: Formoterol, the active ingredient of Foradil, belongs to the class of long-acting beta2adrenergic agonists. 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.
Recommended dose: The dose of Foradil should be individualized to the patient’s needs and should be at the lowest possible dose to fulfill the therapeutic objective. It should not be increased beyond the maximum recommended dose.
Need for concomitant anti-inflammatory therapy in asthma: When treating patients with asthma, use Foradil, a long-acting beta2-agonist (LABA), only as an add-on to an inhaled corticosteroids (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 6-12 years of age, treatment with a combination product containing an ICS and LABA is recommended, except in case where a separate ICS and LABA are required. Foradil should not be used in conjunction with another LABA. Whenever Foradil is prescribed, patients should be evaluated for the adequacy of the antiinflammatory therapy they receive. Patients must be advised to continue anti-inflammatory therapy unchanged after the introduction of Foradil, even if the symptoms improve. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Foradil. Regular monitoring of patients as treatment is stepped down is important. The lowest effective dose of Foradil should be used.
Asthma exacerbations: 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. The physician should reassess asthma therapy if symptoms persist, or if the number of doses of Foradil required to control symptoms increases, because this usually indicates that the underlying condition has deteriorated. Foradil must not be initiated or the dose increased during an asthma exacerbation. 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 when Foradil is given in patients with the following conditions: 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 (QTc >0.44 sec.). Caution should be used when co-administering theophylline and formoterol in patients with pre-existing cardiac conditions. Due to the hyperglycaemic effect of beta2-stimulants, including Foradil, additional blood glucose monitoring is recommended in diabetic patients.
Hypokalaemia: Potentially serious hypokalaemia may occur as a result of beta2-agonist therapy, including Foradil. Hypokalaemia may increase susceptibility to cardiac arrhythmias. Particular caution is advised in patients with severe asthma as hypokalaemia 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.
Incorrect route of administration: There have been reports of patients who have mistakenly swallowed Foradil capsules instead of placing the capsules in the Aerolizer inhalation device. The majority of these ingestions were not associated with side effects. Healthcare providers should discuss with the patient how to correctly use Foradil Aerolizer. If a patient who is prescribed Foradil Aerolizer does not experience breathing improvement, the healthcare provider should ask how the patient is using Foradil Aerolizer.
For full details see prescribing information.

Common: Headache, tremor, Palpitations.
For full details see prescribing information.

Beta-adrenergic blockers may weaken or antagonise the effect of Foradil. Therefore Foradil should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Foradil, as other beta2-agonists, should be administered with caution to patients being treated with drugs such as quinidine, disopyramide, procainamide, phenothiazines, antihistamines, macrolides, monoamine oxidase inhibitors and tricyclic antidepressants or any drug known to prolong the QTc interval, because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc-interval have an increased risk of ventricular arrhythmia. Concomitant administration of other sympathomimetic agents may potentiate the undesirable effects of Foradil. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate the possible hypokalemic effect of beta2-agonists. There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
For full details see prescribing information.

Pregnancy: There is limited data regarding the use of Foradil in pregnant women. Limited animal studies do not indicate Foradil has direct or indirect harmful effects with respect to reproductive toxicity. Its use during pregnancy should be avoided unless there is no safer alternative. Like other beta2-adrenergic stimulants, formoterol may inhibit labour due to a relaxant effect on uterine smooth muscle.
Breast-feeding: There is limited data regarding the use of Foradil during breast-feeding. It is not known whether formoterol passes into human breast milk. The substance has been detected in the milk of lactating rats. Because many drugs are excreted in human milk, mothers taking Foradil should not breast-feed.

Symptoms: An overdose of Foradil is likely to lead to effects that are typical of beta2-adrenergic stimulants: nausea, vomiting, headache, tremor, drowsiness, palpitations, tachycardia, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia, hypertension.
Treatment: Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. Use of cardioselective beta-blockers may be considered, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Serum potassium should be monitored.

Storage: Do not store above 25°C. Store in the original package (blister packs) together with the inhaler. Protect from moisture.