Please refer to the appropriate Summary of Product Characteristics (SmPC) before prescribing
Fixkoh Airmaster 50 microgram/100 microgram/dose inhalation powder, pre-dispensed. Single inhalation provides a delivered dose of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. Corresponds to a pre-metered dose of 50 micrograms of salmeterol and 100 micrograms fluticasone propionate.
Fixkoh Airmaster 50 microgram/250 microgram/dose inhalation powder, pre-dispensed. Single inhalation provides a delivered dose of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. Corresponds to a pre-metered dose of 50 micrograms of salmeterol and 250 micrograms fluticasone propionate.
Fixkoh Airmaster 50 microgram/500 microgram/dose inhalation powder, pre-dispensed. Single inhalation provides a delivered dose of 43 micrograms of salmeterol (as salmeterol xinafoate) and 432 micrograms of fluticasone propionate. Corresponds to a pre-metered dose of 50 micrograms of salmeterol and 500 micrograms fluticasone propionate.
Indication:
Fixkoh Airmaster is indicated in adults and adolescents 12 years of age and older.
Asthma: in the regular treatment of asthma where use of a combination product (long- acting β2 agonist and inhaled corticosteroid) is appropriate. In patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonist, or, patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonist. Note: Fixkoh Airmaster 50 microgram/100 micrograms is not appropriate in adults and children with severe asthma.
Chronic Obstructive Pulmonary Disease (COPD): For the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Dosage and administration:
Fixkoh Airmaster must be used daily for optimal benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Fixkoh Airmaster 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. 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. Patients requiring a long-acting β2 agonist could be titrated to Fixkoh Airmaster 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, a history of mainly daytime symptoms the dose should be given in the morning. Patients should be given the strength of Fixkoh Airmaster 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 100 micrograms fluticasone propionate twice daily.
Or 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 Fixkoh Airmaster may be considered as initial maintenance therapy 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. Once control of asthma is attained treatment should be reviewed and consideration given to use of an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important.
Fixkoh Airmaster is not intended for the initial management of mild asthma.
Fixkoh Airmaster 50 microgram/100 micrograms is not appropriate in adults and children with severe asthma.
Paediatric population
Fixkoh Airmaster is not recommended for use in children aged under 12 years of age.
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.
Method of administration
Inhalation use. Patients must also be advised to rinse their mouth afterwards with water and spit it out and/or brush their teeth after inhaling.
Contraindications:
Hypersensitivity to the active substances or to any of the excipients
Warnings and Precautions:
Deterioration of disease: Fixkoh Airmaster 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 Fixkoh Airmaster during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment. Patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen. Increased requirements for use of reliever medication, 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. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Fixkoh Airmaster. Regular review of patients as treatment is stepped down is important. For patients with COPD experiencing exacerbations, treatment with systemic corticosteroids is indicated, therefore patients should be instructed to seek medical attention if symptoms deteriorate.
Cessation of therapy: Treatment should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under supervision. For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician.
Caution with special diseases: Fixkoh Airmaster should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.
Cardiovascular effects: Rarely, Fixkoh Airmaster may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Fixkoh Airmaster 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.
Hyperglycaemia: Rare reports of increases in blood glucose levels. This should be considered when prescribing to patients with a history of diabetes mellitus.
Paradoxical bronchospasm: 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. Fixkoh Airmaster should be discontinued immediately.
Beta 2 adrenoreceptor agonists: 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.
Excipients: Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Systemic corticosteroid effects: 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). 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.
Adrenal function: 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. These patients should be treated with special care and adrenocortical function regularly monitored. Patients who have required high dose emergency corticosteroid therapy 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.
Pneumonia in patients with COPD: An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features overlap with the symptoms of COPD exacerbations. Risk factors for pneumonia in patients with COPD include current smoking, older age, low BMI and severe COPD.
Visual disturbance: If a patient presents with symptoms such as blurred vision or other visual disturbances, refer to an ophthalmologist for evaluation.
Paediatric population: Fixkoh Airmaster is not recommended for use in children under 12 years of age. Adolescents <16 years taking high doses of fluticasone propionate (typically ≥ 1,000 micrograms/day) may be at particular risk. Systemic effects may occur, particularly at high doses prescribed for long periods. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, acute adrenal crisis and growth retardation in adolescents and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Consideration should be given to referring the adolescent to a paediatric respiratory specialist. It is recommended that the height of adolescents receiving prolonged treatment with inhaled corticosteroid is regularly monitored. The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective control of asthma is maintained.
Pregnancy and lactation:
Pregnancy: Data on pregnant women indicate no malformative or foetal/neonatal toxicity related to salmeterol and fluticasone propionate. Animal studies have shown reproductive toxicity after administration of β2 adrenoreceptor agonists and glucocorticosteroids. Administration of Fixkoh Airmaster to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women.
Breastfeeding: It is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk. Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Fixkoh Airmaster therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Undesirable effects:
For full list of side effects, consult SmPC. Very common and common events include: headache, nasopharyngitis, candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, headache, throat irritation, hoarseness/dysphonia, sinusitis, contusions, cramps, traumatic fractures, arthralgia, myalgia. Serious adverse events: bronchospasm, anaphylaxis, anaphylactic shock, Cushing’s syndrome, growth retardation in children and adolescents, decreased bone mineral density, hyperglycaemia, anxiety, behavioural changes including hyperactivity (mainly in children), depression, aggression (mainly in children), tremor, cataract, glaucoma, blurred vision, palpitations, tachycardia, cardiac arrhythmias, atrial fibrillation, angina.
Overdose:
There are no data available from clinical trials on overdose with Fixkoh Airmaster.
Overdose with both active substances are:
Salmeterol: Dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. If Fixkoh Airmaster therapy has to be withdrawn due to overdose of the β agonist component of the medicinal product, provision of appropriate replacement steroid therapy should be considered. Additionally, hypokalaemia can occur and therefore serum potassium levels should be monitored. Potassium replacement should be considered.
Fluticasone propionate: Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days.
Chronic overdose of inhaled fluticasone propionate: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary. When stabilised, treatment should be continued with an inhaled corticosteroid.
Legal Category:
POM
Pack size:
1 × 60 dose Fixkoh Airmaster
or 2 x 60 dose Fixkoh Airmaster
or 3 x 60 dose Fixkoh Airmaster
or 10 x 60 dose Fixkoh Airmaster
Prices:
50/100mcg £14.47;
Fixkoh Airmaster 50/250mcg £19.29;
Fixkoh Airmaster 50/500mcg £16.12
MA Number:
PL00240/0547, PL00240/0548, PL00240/0549
MA Holder:
Thornton & Ross Ltd. (trading as ‘STADA’)
Linthwaite,
Huddersfield,
HD7 5QH, UK
Date of preparation:
December 2021
Unique ID:
FIX-004a
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to 01484 848164