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FLUTIFORM is a brand name for Fluticasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: • For patients not adequately controlled with inhaled…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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).
Recommended dose for adults, adolescents and children aged 5 years and above:
Flutiform 50 microgram/5 microgram inhaler - two inhalations (puffs) twice daily normally taken in the morning and in the evening. e. Flutiform 125 microgram/5 microgram inhaler - two inhalations (puffs) twice daily. This strength should not be used in children under the age of 12 years.
Undesirable effects which have been associated with Flutiform inhaler during clinical development are given in the table below, listed by system organ class. The following frequency categories form the basis for classification of the undesirable effects as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Adverse Event Frequency Infections and Infestations Oral candidiasis Oral fungal infections Sinusitis Rare Metabolism and Nutrition Disorders Hyperglycaemia Rare Sleep disorders including insomnia Uncommon Abnormal dreams Agitation Rare Psychiatric Disorders Psychomotor hyperactivity, anxiety, depression, aggression, behavioural changes (predominantly in children) Not known Headache Tremor Dizziness UncommonNervous System Disorders Dysgeusia Rare Eye disorders Vision blurred Not known Ear and labyrinth disorders Vertigo Rare Palpitations Ventricular extrasystoles UncommonCardiac Disorders Angina pectoris Tachycardia Rare Vascular disorders Hypertension Rare Exacerbation of asthma Dysphonia Throat irritation UncommonRespiratory, Thoracic and Mediastinal Disorders Dyspnoea Cough Rare Dry mouth UncommonGastrointestinal disorders Diarrhoea Dyspepsia Rare Rash UncommonSkin and subcutaneous tissue disorders Pruritus Rare Musculoskeletal and Connective Tissue Disorders Muscle spasms Rare General disorders and administration site conditions Peripheral oedema Asthenia Rare As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straight away. Flutiform inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
The management of asthma should normally follow a stepwise programme and patients’ responses should be monitored clinically and by lung function tests. Flutiform inhaler 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 of Flutiform inhaler 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 Flutiform inhaler 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 Flutiform inhaler. 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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e. Flutiform 250 microgram/10 microgram inhaler - two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents and children. 3). Flutiform inhaler in any strength is not recommended for use in children less than 5 years of age; Flutiform inhaler should not be used in this young age group.
Special patient groups:
There is no need to adjust the dose in elderly patients. 2). 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 microgram /5 microgram 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® Flow-Vu® is the recommended spacer device. 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. Method of administration For inhalation use. To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professionals.
The correct use of the pressurised metered dose inhaler (pMDI) is essential for successful treatment. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use and pictograms in the leaflet.
The actuator has an integrated counter which counts down the number of actuations (puffs) remaining. This counter is also colour coded. It starts off green then, when there are less than 50 puffs (actuations) left it changes to yellow and when there are less than 30 puffs (actuations) left it changes to red.
The counter counts down from 120 to 60 in intervals of 10, and from 60 to 0 in intervals of 5. When this is getting near to […]
Since Flutiform inhaler contains both fluticasone propionate and formoterol fumarate, the same pattern of undesirable effects as reported for these substances may occur. The following undesirable effects are associated with fluticasone propionate and formoterol fumarate, but have not been seen during the clinical development of Flutiform inhaler: Fluticasone propionate: Hypersensitivity reactions including, urticaria, pruritus, angiooedema (mainly facial and oropharyngeal), anaphylactic reactions.
Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These may include Cushing’s Syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, contusion, skin atrophy and susceptibility to infections.
The ability to adapt to stress may be impaired. The systemic effects described, however, are much less likely to occur with inhaled corticosteroids than with oral corticosteroids. Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression and acute adrenal crisis.
Additional systemic corticosteroid cover may be required during periods of stress (trauma, surgery, infection).
Formoterol fumarate:
Hypersensitivity reactions (including hypotension, urticaria, angioneurotic oedema, pruritus, exanthema), QTc interval prolongation, hypokalaemia, nausea, myalgia, increased blood lactate levels. Treatment with β2 agonists such as formoterol may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Hypersensitivity reactions have been reported in patients using inhaled sodium cromoglicate as an active ingredient. Whilst Flutiform inhaler contains only a low concentration of sodium cromoglicate as an excipient, it is unknown if hypersensitivity reactions are dose dependent.
In the unlikely event of a hypersensitivity reaction to Flutiform inhaler, treatment should be initiated in accordance with standard treatment for any other hypersensitivity reaction, which may include the use of antihistamines and other treatment as required.
Flutiform inhaler may need to be discontinued immediately and an alternative asthma therapy may need to be initiated if necessary. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using the product.
Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst continuing the treatment with Flutiform inhaler. Paediatric population Possible systemic effects as reported for the individual components of Flutiform inhaler include Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents.
Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability. Studies conducted with Flutiform inhaler demonstrated similar safety and tolerability profile as compared to fluticasone monotherapy in children aged 5-12 years and fluticasone/salmeterol in children aged 4-12.
Long term treatment with Flutiform inhaler for 24 weeks in 208 children did not show any indication of growth retardation or adrenal suppression. Another pharmacodynamic study conducted in children aged 5- 12 years showed similar lower leg growth rate as measured by knemometry after treatment with Flutiform inhaler as compared to fluticasone monotherapy for 2 weeks.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
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.
2). 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. 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.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straight away.
Flutiform inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. 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.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in […]