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Aerivio Spiromax is a brand name for Salmeterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Aerivio Spiromax is indicated for use in adults aged 18 years and older only. Asthma Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate: - patients not adequately controlled on a…
Verbatim from this product's EMA label. Tap a section to expand.
Aerivio Spiromax is indicated in adults 18 years of age and older only.
Medicinal product no longer authorised 3 Posology Route of administration:
Inhalation use Patients should be made aware that Aerivio Spiromax must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of the salmeterol/fluticasone propionate 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. Aerivio Spiromax is not available on the market at strengths lower than 50/500 microgram. When it is appropriate to titrate down to a lower strength not available for Aerivio Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.
Patients should be given a strength of salmeterol/fluticasone propionate inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Aerivio Spiromax is only appropriate for use in the treatment of patients with severe asthma.
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 aged 18 years and older. One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid and then ultimately 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 with 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. Aerivio Spiromax is for the treatment of patients with severe asthma only. It should not be used for the treatment of patients with mild or moderate asthma or for the initiation of treatment for patients with severe asthma unless the requirement for such a high dose of the corticosteroid together with a long-acting β2 agonist has been established previously.
Summary of safety profile As Aerivio Spiromax contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. There is no incidence of additional adverse events following concurrent administration of the two active substances.
Adverse reactions 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 toMedicinal product no longer authorised 10 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency 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 KnownMedicinal product no longer authorised 11 System Organ Class Adverse reaction Frequency Cardiac disorders Palpitations Tachycardia Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Atrial fibrillation Angina pectoris Uncommon Uncommon Rare Uncommon Uncommon Respiratory, thoracic and 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 and 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
Asthma Aerivio Spiromax is for use in patients with severe asthma only. It 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 Aerivio Spiromax 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 Aerivio Spiromax.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Aerivio Spiromax. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma 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 the inhaled corticosteroid and therefore a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.
Regular review of patients as treatment is stepped down is important. The lowest dose of inhaled corticosteroid should be used. COPD 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 Aerivio Spiromax.
Cessation of therapy Treatment with Aerivio Spiromax 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.
Medicinal product no longer authorised 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Aerivio Spiromax is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time. Patients should commence treatment with a fixed- dose combination containing a lower dose of the corticosteroid component and will then be titrated up in respect of the corticosteroid dose until control of asthma is achieved.
Once control of asthma is achieved patients should be reviewed regularly and the dose of inhaled corticosteroid titrated downwards as appropriate to maintain disease control. Medicinal product no longer authorised 4 Paediatric population Aerivio Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years.
The safety and efficacy of Aerivio Spiromax in children and adolescents aged less than 18 years of age has not been established. No data are available. COPD 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 on the use of Aerivio Spiromax in patients with hepatic impairment. Method of administration/Instructions for use The Spiromax device is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece.
1 – last five paragraphs) Required training Aerivio Spiromax should be used correctly in order to achieve effective treatment. As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
All patients should be provided with training by the prescribing Health Care Professional on how to use Aerivio Spiromax. This is to ensure that they understand how to use the inhaler correctly, and so that they understand the need to breathe in forcefully when inhaling to obtain the required dose.
It is important to inhale forcefully to ensure optimal dosing. The use of Aerivio Spiromax follows three simple steps: open, breathe and close which are outlined below.
Open:
Hold the Spiromax with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Breathe:
Breathe out gently (as far as is comfortable). Do not breathe through your inhaler. Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler. Breathe in forcefully and deeply through the mouthpiece.
Remove the Spiromax device from the mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Close:
Breathe out gently and close the mouthpiece cover. Patients should not block the air vents at any time, or breathe out through the Spiromax device when they are […]
Caution with special diseases Aerivio Spiromax 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. Aerivio Spiromax 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. Parodoxical 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. Medicinal product no longer authorised 6 βeta 2 adrenoreceptor agonists The pharmacological 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 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. Visual disturbance 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.
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 1000 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 […]