Presentation and Status in Health Basket
Solution for Inhalation
This drug is not intended for the initial management of asthma. The dosage of the components of this drug is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta2-agonists and/or corticosteroids by individual inhalers should be prescribed. There are two treatment approaches:
Maintenance therapy: This formulation is taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator. Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Dose recommendations for adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations.
Maintenance and reliever therapy: This drug is taken as regular maintenance treatment and as needed in response to asthma symptoms. Patients take their daily maintenance dose of this drugand in addition take this drug as needed in response to asthma symptoms. Patients should be advised to always have This drug available for rescue use. This formulation maintenance and reliever therapy should especially be considered for patients with: Not fully controlled asthma and in need of reliever medication. Asthma exacerbations in the past requiring medical intervention. Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of this drug as-needed inhalations.
Dose recommendations for adults 18 years and above: The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken.
The maximum daily dose is 8 inhalations: Patients requiring frequent use of rescue inhalations daily should be strongly recommended to seek medical advice. Their asthma should be reassessed and their maintenance therapy should be reconsidered.
Dose recommendations for children and adolescents under 18 years: The safety and efficacy in children and adolescents under 18 years of age have not been established yet. No data are available in children under 12 years of age. Only limited data are available in adolescents between 12 and 17 years of age. Therefore this formulation is not recommended for children and adolescents under 18 years until further data become available.
Patients should be regularly monitores by doctor, so that the dosage remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone. Patients should be advised to take This drug every day even when asymptomatic.
COPD: Dose recommendations for adults 18 years and above: Two inhalations twice daily.
Special patient groups: There is no need to adjust the dose in elderly patients. There are no data available for use in patients with hepatic or renal impairment.
For method of administration: See prescribing information for full details.
Asthma: Indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
– Patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled rapid-acting beta2-agonist or
– Patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
COPD: Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Hypersensitivity to beclometasone dipropionate, formoterol fumarate dihydrate and/or any of the excipients.
This drug should be used with caution (which may include monitoring) in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, particularly acute myocardial infarction, ischaemic heart disease, congestive heart Failure, occlusive vascular diseases, particularly arteriosclerosis, arterial hypertension and aneurysm.
Caution is also required when this drug is used by patients with thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia.
Potentially serious hypokalaemia may result from beta2-agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatment with other drugs which can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics.
The inhalation of formoterol may cause a rise in blood glucose levels. Therefore blood glucose should be closely monitored in patients with diabetes.
If anaesthesia with halogenated anaesthetics is planned, it should be ensured that This drug is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
As with all inhaled medication containing corticosteroids, this drug should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
It is recommended that treatment with this drug should not be stopped abruptly.
If patients find the treatment ineffective medical attention must be sought. Increasing use of rescue bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Sudden and progressive deterioration in control of asthma or COPD is potentially life- threatening and the patient should undergo urgent medical assessment. Consideration should be given to the need for increased treatment with corticosteroids, either inhaled or oral therapy, or antibiotic treatment if an infection is suspected.
Patients should not be initiated on this drug during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Foster. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Foster.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and rapidness of breath after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator. Foster should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Foster should not be used as the first treatment for asthma.
For treatment of acute asthma attacks patients should be advised to have their rapid-acting bronchodilator available at all times, either Foster (for patients using Foster as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for patients using Foster as maintenance therapy only).
Patients should be reminded to take Foster daily as prescribed even when asymptomatic. The reliever inhalations of Foster should be taken in response to asthma symptoms but are not intended for regular prophylactic use, e.g. before exercise. For such use, a separate rapid-acting bronchodilator should be considered.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Foster. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Foster should be used.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhaled than with oral corticosteroids.
Possible systemic effects include: Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma and more rarely, a range of psycological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Therefore, it is important that the patient is reviewed regularly, and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
See prescribing information for full details
Common: Pharyngitis, oral candidiasis and pneumonia (in COPD patients).
See prescribing information for full details.
Pharmacokinetic interactions: Beclometasone dipropionate undergoes a very rapid metabolism via esterase enzymes.
Beclometasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.
Pharmacodynamic interactions: Beta-blockers (including eye drops) should be avoided in asthmatic patients. If beta-blockers are administered for compelling reasons, the effect of formoterol will be reduced or abolished. On the other hand, concomitant use of other beta-adrenergic drugs can have potentially additive effects, therefore caution is required when theophylline or other beta-adrenerigic drugs are prescribed concomitantly with formoterol. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias. In addition L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards beta2-sympathomimetics.
Concomitant treatment with monoamine oxidase inhibitors including agents with similar properties such as furazolidone and procarbazine may precipitate hypertensive reactions. There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists. Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides. this drug contains a small amount of ethanol. There is a theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole.
Pregnancy and Lactation
Pregnancy: Foster should only be used during pregnancy if the expected benefits outweigh the potential risks.
Lactation: Administration of Foster to women who are breast-feeding should only be considered if the expected benefits outweigh the potential risks.
See prescribing information for full details.
Inhaled doses of this drug up to twelve cumulative actuations (total beclometasone dipropionate 1200 micrograms, formoterol 72 micrograms) have been studied in asthmatic patients. The cumulative treatments did not cause abnormal effect on vital signs and neither serious nor severe adverse events were observed.
Excessive doses of formoterol may lead to effects that are typical of beta2-adrenergic agonists: nausea, vomiting, headache, tremor, somnolence, palpitations, tachycardia, ventricular arrhythmias, prolongation of QTc interval, metabolic acidosis, hypokalaemia, hyperglycaemia.
In case of overdose of formoterol, supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-adrenergic blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm. Serum potassium should be monitored.
Acute inhalation of beclometasone dipropionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function recovers in a few days, as verified by plasma cortisol measurements. In these patients treatment should be continued at a dose sufficient to control asthma.
Chronic overdose of inhaled beclometasone dipropionate: risk of adrenal suppression Monitoring of adrenal reserve may be necessary. Treatment should be continued at a dose sufficient to control asthma.
Storage: Store in a refrigerator (2-8°C) (for a maximum of 15 months). After dispensing: Do not store above 25°C (for a maximum of 5 months).