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Dose recommendations for adults 18 years and above:
Two inhalations twice daily.
The maximum daily dose is 4 inhalations.
The drug should be used as maintenance therapy only. A lower strength (Foster 100/6) is available for maintenance and reliever therapy.
Indicated in the regular treatment of asthma in adults 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.
Hypersensitivity to active substances or to any of the excipients.
This formulation should be used with caution (which may include monitoring) in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, severe heart failure, severe arterial hypertension and aneurysm.
Caution should also be observed when treating patients with known or suspected prolongation of the QTc interval, either congenital or drug induced (QTc > 0.44 seconds). Formoterol itself may induce prolongation of the QTc interval.
Caution is also required when it 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. Caution is also recommended in unstable asthma when a number of “rescue” bronchodilators may be used. It is recommended that serum potassium levels are monitored in such situations.
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 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 this drug. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on this agent.
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 200/6 should be discontinued immediately, the patient assessed, and alternative therapy instituted if necessary.
This formulation 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.
Patients should be reminded to take this drug daily as prescribed even when asymptomatic.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose. Regular review of patients as treatment is stepped down is important. The lowest effective dose should be used (a lower strength Foster 100/6 is available).
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 psychological or behavioral 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.
Single dose pharmacokinetic data have demonstrated that the use of Foster 200/6 with AeroChamber Plus® spacer device in comparison to the use of standard actuator, does not increase the total systemic exposure to formoterol and reduces the systemic exposure to beclometasone-17-monopropionate, while there is an increase for unchanged beclometasone dipropionate that reaches systemic circulation from the lung; however, since the total systemic exposure to beclometasone dipropionate plus its active metabolite does not change, there is no increased risk of systemic effects when using Foster 200/6 with the named spacer device.
Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Children aged less than 16 years taking/inhaling higher than recommended doses of beclomethasone dipropionate may be at particular risk. Situations which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Care should be taken when transferring patients to this formulation therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
Patients transferring from oral to inhaled corticosteroids may remain at risk of impaired adrenal reserve for a considerable time. Patients who have required high dose emergency corticosteroid therapy in the past or have received prolonged treatment with high doses of inhaled corticosteroids may also be at risk. This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered. The extent of the adrenal impairment may require specialist advice before elective procedures.
Patients should be advised to rinse the mouth or gargle with water or brush the teeth after inhaling the prescribed dose to minimise the risk of oropharyngeal candida infection.
Foster 200/6 contains a small amount of ethanol (alcohol), less than 100 mg per actuation. At normal doses the amount of ethanol is negligible and does not pose a risk to patients.
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Pharyngitis, oral candidiasis, headache, dysphonia. See prescribing information for full details.
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.
-adrenergic blockers can weaken or inhibit the effect of formoterol. Foster 200/6 should therefore not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons.
Pregnancy and Lactation
There are no relevant clinical data on the use of this drug in pregnant women.
See prescribing information for full details.
There are no relevant clinical data on the use of this drug in lactation in humans.
See prescribing information for full details.
Inhaled doses 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.
See prescribing information for full details.
Prior to dispensing to the patient:
At the pharmacy store in a refrigerator (temperature 2-8°C) for a maximum of 18 months.
Once the product is dispensed to a patient, it should be stored at room temperature (below 25°C) for a maximum of 3 months.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.