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  • Flutiform
    / Rafa


    Active Ingredient *
    Fluticasone Propionate 50, 125, 250 mcg
    Formoterol Fumarate 5 mcg, 10 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Inhaler

    50 mcg/5 mcg

    partial basket chart 51480 6533

    Inhaler

    125 mcg/5 mcg

    partial basket chart 51485 6534

    Inhaler

    250 mcg/10 mcg

    partial basket chart 51486 6535

    Dosage

    For inhalation use.
    Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of flutiform inhaler they are receiving 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. Once control of asthma is achieved with the lowest strength of flutiform inhaler administered twice daily treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Regular review of patients as treatment is stepped down is extremely important.
    There are no data available for use of flutiform inhaler in patients with COPD. flutiform inhaler should not be used in patients with COPD.
    Patients should be given the strength of flutiform inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: flutiform 50 microgram/5 microgram per actuation, strength is not appropriate in adults and adolescents with severe asthma. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily dose (in micrograms). If an individual patient should require doses outside the recommended dose regimens, appropriate doses of the β2 agonist and the inhaled corticosteroid in separate inhalers, or appropriate doses of the inhaled corticosteroid alone, should be prescribed.
    flutiform inhaler is delivered by a press-and-breathe pressurised metered dose inhaler (pMDI) which also contains an integrated dose indicator. Each inhaler will provide at least 120 actuations (60 doses).
    flutiform 50 /5 inhaler – only
    Recommended dose for adults and adolescents aged 12 years and above:
    flutiform 50 /5 inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening.
    If the patient’s asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product – i.e. flutiform 125 /5 inhaler – two inhalations (puffs) twice daily.
    For adults only: The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product – i.e. flutiform 250 /10 inhaler – two inhalations (puffs) twice daily. This highest strength is for use in adults only, it should not be used in adolescents aged 12 years and above.
    Children under 12 years: Experience in children under the age of 12 years is limited. flutiform inhaler in any strength is not recommended for use in children less than 12 years of age; flutiform inhaler should not be used in this young age group.
    flutiform 125 /5 inhaler – only
    Recommended dose for adults and adolescents aged 12 years and above: flutiform 125 /5 inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening.
    Patients may be transferred to the lowest strength of this combination product i.e. flutiform 50 /5 inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
    For adults only: The total daily dose can be further increased if asthma remains poorly controlled by administering the highest strength of this combination product – i.e. flutiform 250 /10 inhaler – two inhalations (puffs) twice daily. This highest strength is for use in adults only, it should not be used in adolescents aged 12 years and above.
    Children under 12 years: No data are available for this strength of flutiform inhaler in children. Experience in children under the age of 12 years is limited. flutiform inhaler in any strength is not recommended for use in children less than 12 years of age; flutiform inhaler should not be used in this young age group.
    flutiform 250 /10 inhaler – only
    Recommended dose for adults: flutiform 250 /10 inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening.
    Patients may be transferred to a lower strength of this combination product i.e. flutiform 125 /5 inhaler or ultimately flutiform 50 /5 inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
    Adolescents under 18 years and children: No data are available for this strength of flutiform inhaler in children or adolescents. Experience in
    children is limited. flutiform inhaler in any strength is not recommended for use in children less than 12 years of age; flutiform inhaler should not be used in this young age group.
    flutiform 250 /10 inhaler should not be used in adolescents. However there are lower strengths available i.e. 50 microgram/5 microgram per actuation or 125 microgram/5 microgram per actuation which may be used in adolescents.
    flutiform inhaler – all strengths
    Special patient groups:
    There is no need to adjust the dose in elderly patients.
    There are no data available for use of flutiform inhalerin patients with hepatic or renal impairment. These patients should be regularly monitored by a physician to ensure titration to the lowest dose at which effective control of symptoms is maintained. As the fractions of fluticasone and formoterol which reach systemic circulation are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment.
    General information:
    Inhaled corticosteroids alone are the first line of treatment for most patients. flutiform inhaler is not intended for the initial treatment of mild asthma. For patients with severe asthma the inhaled corticosteroid therapy should be established before prescribing a fixed-dose combination product.
    Patients should be made aware that flutiform inhaler must be used daily for optimum benefit, even when asymptomatic.
    Patients using flutiform inhaler should not use additional long-acting β2 agonists for any reason. If asthma symptoms arise in the period between doses, an inhaled, short-acting β2 agonist should be taken for immediate relief.
    For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is two inhalations twice daily of flutiform 125 /5 inhaler.
    Use of a spacer device with flutiform inhaler is recommended in patients who find it difficult to synchronise aerosol actuation with inspiration of breath. The AeroChamber Plus® is the only spacer device recommended for use with flutiform inhaler.
    Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.
    Re-titration to the lowest effective dose should always follow the introduction of a spacer device.
    See prescribing information for full details.


    Indications

    The regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long – acting β2 agonist) is appropriate:
    For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist.
    For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.


    Contra-Indications

    Hypersensitivity to any of the active substances or to any of the excipients.


    Special Precautions

    The management of asthma should normally follow a stepwise programme and patients’ responses should be monitored clinically and by lung function tests.
    This product should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.
    The prophylactic use this product in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered.
    Patients should be reminded to take their maintenance dose as prescribed, even when asymptomatic.
    Patients should not be initiated on Flutiform Inhaler 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 product. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on flutiform inhaler. flutiform inhaler should not be used as the first treatment for asthma.
    If increasing use of short-acting bronchodilators to relieve asthma is required, if short-acting bronchodilators become less effective, or ineffective or if asthma symptoms persist, the patient should be reviewed by their doctor as soon as possible as any of these may indicate a deterioration in asthma control and their treatment may need to be changed.
    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 increasing corticosteroid therapy. The patient should also be medically reviewed when the current dosage of flutiform inhaler has failed to give adequate control of asthma. Consideration should be given to additional corticosteroid therapies.
    Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of flutiform inhaler. Regular review of patients as treatment is stepped down is important. The lowest effective dose of flutiform inhaler should be used . Treatment with flutiform inhaler should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under the supervision of a prescriber.
    An exacerbation of the clinical symptoms of asthma may be due to an acute respiratory tract bacterial infection and treatment may require appropriate antibiotics, increased inhaled corticosteroids and a short course of oral corticosteroids. A rapid-acting inhaled bronchodilator should be used as rescue medication. As with all inhaled medication containing corticosteroids, Flutiform Inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway. Any such infections must always be adequately treated if Flutiform inhaler is being used.
    Flutiform inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure.
    Potentially serious hypokalaemia may result from high doses of β2 agonists. Concomitant treatment of β2 agonists with drugs which can induce hypokalaemia or potentiate a hypokalaemic effect, e.g. xanthine derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β2 agonist. Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia adverse effects is increased. It is recommended that serum potassium levels are monitored during these circumstances.
    Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.
    As for all β2 agonists, additional blood sugar controls should be considered in diabetic patients.
    Care should be taken when transferring patients to Flutiform inhaler therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
    See prescribing information for full details.


    Side Effects

    Uncommon (≥1/1,000 and <1/100): Hyperglycaemia, headache, tremor, dizziness, dysgeusia palpitations, ventricular extrasystoles, exacerbation of asthma, dysphonia, throat irritation, dry mouth and peripheral oedema.
    See prescribing information for full details.


    Drug interactions

    No formal drug interaction studies have been performed with this product.
    Flutiform inhaler contains sodium cromoglicate at non-pharmacological levels. Patients should not discontinue any cromoglicate containing medication.
    Fluticasone propionate, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin) together with Flutiform inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible. Particularly co-medication of ritonavir should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects. Information about this interaction is lacking for inhaled fluticasone propionate, but a marked increase in fluticasone propionate plasma levels is expected. Cases of Cushing’s syndrome and adrenal suppression have been reported.
    In addition L-Dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2 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 use of other β adrenergic drugs can have a potentially additive effect. Hypokalaemia may increase the risk of arrhythmias in patients who are treated with digitalis glycosides.
    Formoterol fumarate, as with other β2 agonists, should be administered with extreme caution to patients being treated with tricyclic antidepressants or monoamine oxidase inhibitors, and during the immediate two week period following their discontinuation, or other drugs known to prolong the QTc interval such as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide, and antihistamines. Drugs that are known to prolong the QTc interval can increase the risk of ventricular arrhythmias.
    If additional adrenergic drugs are to be administered by any route, they should be used with caution, because the pharmacologically predictable sympathetic effects of formoterol may be potentiated.
    Beta adrenergic receptor antagonists (β blockers) and formoterol fumarate may inhibit the effect of each other when administered concurrently. Beta blockers may also produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with β blockers and this includes β blockers used as eye drops for treatment of glaucoma. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of β blockers in patients with asthma. In this setting, cardioselective β blockers could be considered, although they should be administered with caution.


    Pregnancy and Lactation

    Pregnancy: There are limited data on the use of fluticasone propionate and formoterol fumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this product is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used. Because of the potential for β agonist interference with uterine contractility, use of this product for management of asthma during labour should be restricted to those patients in whom the benefit outweighs the risks.
    Lactation: It is not known whether fluticasone propionate or formoterol fumarate is excreted in human breast milk. A risk to the suckling child cannot be excluded. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Flutiform inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.


    Overdose

    There are no data available from clinical trials on overdose with flutiform inhaler, however, data on overdose with both single drugs are given below:
    Formoterol fumarate: An overdose of formoterol would likely lead to an exaggeration of effects that are typical for β2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.
    Treatment of formoterol overdose consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of cardio selective β receptor blockers may be considered, bearing in mind that such medication can induce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial in cases of formoterol overdose. Cardiac monitoring is recommended.
    If flutiform inhaler therapy has to be withdrawn due to overdose of the β agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. Serum potassium levels should be monitored as hypokalaemia can occur. Potassium replacement should be considered.
    Fluticasone propionate: Acute overdose with fluticasone propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.
    There are reports of rare cases of acute adrenal crisis. Children and adolescents <16 years taking high doses of fluticasone propionate: (typically ≥1000 microgram/day) may be at particular risk. Presenting symptoms can be vague (anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting and hypotension). Typical symptoms of an adrenal crisis are decreased level of consciousness, hypoglycaemia and/or seizures.
    Following chronic use of very high doses a degree of atrophy of the adrenal cortex and HPA axis suppression may occur. Monitoring of adrenal reserve may be necessary. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
    In the management of chronic overdose oral or systemic corticosteroids may be required in situations of stress. All patients deemed to be chronically overdosed should be treated as if steroid dependent with a suitable maintenance dose of a systemic corticosteroid. When stabilized, treatment should be continued with an inhaled corticosteroid at the recommended dose for symptom control.


    Important notes

    In use shelf-life: 3 months after opening the foil pouch.
    Storage: Do not store above 25°C.


    Manufacturer
    Fisons Limited, UK
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