Loading…
FUSACOMB EASYHALER is a brand name for Fluticasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Asthma Fusacomb Easyhaler is indicated in the regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonist or - patients already…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Patients should be made aware that Fusacomb Easyhaler must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Fusacomb Easyhaler 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. e. 50 micrograms salmeterol and 100 micrograms fluticasone propionate) other fixed-dose combination products containing these two active ingredients are available.
Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone. As an alternative, patients requiring a long-acting β2 agonist could be titrated to Fusacomb Easyhaler given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control.
In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning. Patients should be given the strength of Fusacomb Easyhaler containing the appropriate fluticasone propionate dosage for the severity of their disease.
If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.
Recommended Doses:
Asthma Adults and adolescents 12 years and older: One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. or One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
A short-term trial of salmeterol/fluticasone propionate may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.
In these cases, the recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily, a strength which is available for other similar fixed-dose combination products containing these two active ingredients.
As Fusacomb Easyhaler contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.
Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) and not known (cannot be estimated from the available data).
Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account. 4) Uncommon Rare4 Not known Cardiac Disorders Palpitations Tachycardia Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles) Atrial fibrillation Angina pectoris Uncommon Uncommon Rare Uncommon Uncommon System Organ Class Adverse Event Frequency Respiratory, Thoracic & Mediastinal Disorders Nasopharyngitis Throat irritation Hoarseness/dysphonia Sinusitis Paradoxical bronchospasm Very Common2,3 Common Common Common1,3 Rare4 Skin and subcutaneous tissue disorders Contusions Common1,3 Musculoskeletal & Connective Tissue Disorders Muscle cramps Traumatic fractures Arthralgia Myalgia Common Common1,3 Common Common 1.
Reported commonly in placebo 2. Reported very commonly in placebo 3. Reported over 3 years in a COPD study 4. 4
Deterioration of disease Fusacomb Easyhaler 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 inhaler to be used for relief in an acute asthma attack available at all times.
Patients should not be initiated on Fusacomb Easyhaler 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 Fusacomb Easyhaler.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Fusacomb Easyhaler. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of control and patients should be reviewed by a physician.
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. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Fusacomb Easyhaler.
Regular review of patients as treatment is stepped down is important. 2). For patients with COPD experiencing exacerbations, treatment with systemic corticosteroids is typically indicated, therefore patients should be instructed to seek medical attention if symptoms deteriorate with Fusacomb Easyhaler.
Treatment with Fusacomb Easyhaler should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician.
1 (lactose, which contains small amounts of milk protein).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluticasone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important.
A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. In general inhaled corticosteroids remain the first line treatment for most patients.
Fusacomb Easyhaler is not intended for the initial management of mild asthma. Salmeterol/fluticasone propionate 50 microgram/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed- combination can be used in patients with severe asthma.
Paediatric population Fusacomb Easyhaler should not be used in children younger than 12 years.
COPD Adults:
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Special patient groups:
There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Fusacomb Easyhaler in patients with hepatic impairment. Method of administration Inhalation use.
Instructions for correct use of Fusacomb Easyhaler:
The inhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note:
It is important to instruct the patient • to carefully read the instructions for use in the patient information leaflet which is packed together with each Fusacomb Easyhaler • to hold the inhaler upright, gripping it between finger and thumb • to vigorously shake the inhaler up and down 3 to 5 times before actuation • to actuate (click) the inhaler before inhalation • to breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs • to hold breath after inhaling for at least 5 seconds • never to breathe out through the mouthpiece as this will result in a reduction in the delivered dose.
Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure. • never to actuate the device more than once without inhalation of the powder.
Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure. • to always replace the dust cap (and, if in use, close the protective cover) after use to prevent accidental actuation of the device (which could result in either overdosing or under dosing the patient when subsequently used) • to rinse the mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
• water should never be used for cleaning the inhaler because the powder is sensitive to moisture • to replace Fusacomb Easyhaler when the counter reaches zero even though powder could still be observed within the inhaler.
As with all inhaled medication containing corticosteroids, Fusacomb Easyhaler should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway. Appropriate treatment should be promptly instituted, if indicated.
g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Fusacomb Easyhaler should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
8) and this should be considered when prescribing to patients with a history of diabetes mellitus. Paradoxical bronchospasm 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 bronchodilator and should be treated straightaway. Fusacomb Easyhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Systemic corticosteroid effects 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, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents).
It is important, therefore, 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. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1 000 micrograms. 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, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Therefore these patients should be treated with special care and adrenocortical function regularly monitored.
Patients who have required high dose emergency corticosteroid therapy in the past 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. Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should […]