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BroPair Spiromax is a brand name for Salmeterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BroPair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonists.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Patients should be advised to take BroPair Spiromax every day, even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief. 75/202 micrograms high ICS dose), the patients’ disease severity, their previous asthma therapy including ICS dose as well as the patients’ current control of asthma symptoms should be considered.
Patients should be regularly reassessed by a doctor, so that the strength of the salmeterol/fluticasone propionate 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.
Note that the delivered doses for BroPair Spiromax are different from other salmeterol/fluticasone containing products on the market. The different dose strengths (medium/high doses of fluticasone) for different products do not necessarily correspond to each other, thus the products are not interchangeable based on the corresponding dose strengths.
Medicinal product no longer authorised 3 Adults and adolescents 12 years and older. 75 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. 75 micrograms salmeterol and 202 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 salmeterol/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. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or inhaled corticosteroid should be prescribed.
Special populations Elderly (>65 years) There is no need to adjust the dose in elderly patients Renal impairment There is no need to adjust the dose in patients with renal impairment. Hepatic impairment There are no data available on the use of BroPair Spiromax in patients with hepatic impairment.
Paediatric population The posology in patients 12 years of age and older is the same posology as in adults. The safety and efficacy in paediatric patients below 12 years of age have not been established. No data are available. Method of administration Inhalation use.
Summary of the safety profile As this medicinal product contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
4%). Tabulated list of adverse reactions Medicinal product no longer authorised 9 Adverse reactions which have been associated with fluticasone propionate and salmeterol are presented 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), very rare (<1/10,000) and not known (cannot be estimated from the available data). Frequencies were derived from clinical trial data.
Table 1:
Tabulated list of adverse reactions System Organ Class Adverse reaction Frequency Infections and infestations Oral candidiasisa Common1 Influenza Common Nasopharyngitis Common Rhinitis Common Sinusitis Common Pharyngitis Uncommon Respiratory tract infection Uncommon Oesophageal candidiasis Rare Endocrine disorders Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents Rare1 Metabolism and nutrition disorders Hypokalaemia Common2 Hyperglycaemia Uncommon Psychiatric disorders Anxiety Uncommon Insomnia Uncommon Behavioural changes, including hyperactivity and irritability, especially in children Uncommon Nervous system disorders Headache Common Dizziness Common Tremor Uncommon Eye disorders Cataract Uncommon Glaucoma Rare1 Vision blurred Not known1 Cardiac disorders Palpitations Uncommon1 Tachycardia Uncommon Atrial fibrillation Uncommon Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles) Rare Respiratory, thoracic and mediastinal disorders Cough Common Throat irritation Common Hoarseness/dysphonia Common Oropharyngeal pain Common Rhinitis allergic Uncommon Nasal congestion Uncommon Paradoxical bronchospasm Rare1 Gastrointestinal disorders Abdominal pain upper Uncommon Dyspepsia Uncommon Skin and subcutaneous tissue disorders Dermatitis contact Uncommon Musculoskeletal and connective tissue disorders Back pain Common Myalgia Common Pain in extremity Uncommon Injury, poisoning and procedural complications Laceration Uncommon Medicinal product no longer authorised 10 a.
Deterioration of disease Salmeterol/fluticasone propionate 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 rescue inhaler available to be used for relief in an acute asthma attack at all times.
Patients should not be initiated on salmeterol/fluticasone propionate 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 salmeterol/fluticasone propionate.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on salmeterol/fluticasone propionate. 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 inhaled corticosteroid therapy. Cessation of therapy Treatment with salmeterol/fluticasone propionate should not be stopped abruptly in patients with asthma due to risk of exacerbation.
Therapy should be down-titrated under physician supervision. Coexisting conditions Salmeterol/fluticasone propionate 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. , supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Salmeterol/fluticasone propionate should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with thyrotoxicosis.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Salmeterol in European Union.
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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.
The 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. Required training This medicinal product 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 this medicinal product.
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 this medicinal product follows 3 simple steps: open, breathe, and close, which are outlined below.
Open:
Hold the device with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when 1 click is heard.
Breathe:
Breathe out fully. Do not breathe out through your inhaler. Put the mouthpiece in your mouth and close your lips tightly around it. Breathe in forcefully and deeply through the mouthpiece. Remove the device from the mouth and hold the breath for 10 seconds or as long as comfortable for you.
Close:
Breathe out gently and close the mouthpiece cover. Medicinal product no longer authorised 4 Patients should not block the air vents at any time, or breathe out through the device when they are preparing the “Breathe” step. Patients are not required to shake the inhaler prior to use.
4). Patients may notice a taste when using this medicinal product due to the lactose excipient. Patients should be advised to keep their inhaler dry and clean at all times by gently wiping the mouthpiece with a dry cloth or tissue as needed.
Includes oral candidiasis, oral fungal infection, oropharyngeal candidiasis, and oropharyngitis fungal 1. 4 2. 5 Description of selected adverse reactions Specific β2 agonist treatment effects 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.
4). 4). Paediatric population The safety and efficacy of BroPair Spiromax in paediatric patients below the age of 12 years have not been established. 4 Special warnings and precautions for use). The growth of paediatric patients receiving orally inhaled corticosteroids, including salmeterol/fluticasone propionate, should be monitored routinely.
To minimize the systemic effects of orally inhaled corticosteroids, including salmeterol/fluticasone propionate titrate each patient’s dosage to the lowest dosage that effectively controls his/her symptoms. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Medicinal product no longer authorised 5 Hypokalaemia and hyperglycaemia Beta-adrenergic agonist medicines may produce significant hypokalaemia in some patients, possibly through intracellular shunting, which has the potential to product adverse cardiovascular effects.
The decrease in serum potassium is usually transient, not requiring supplementation. 8). 8) and this should be considered when prescribing to patients with a history of diabetes mellitus. Salmeterol/fluticasone propionate should be used with caution in patients with diabetes mellitus, uncorrected hypokalemia, or patients predisposed to low levels of serum potassium.
8). This should be treated immediately with a short-acting inhaled bronchodilator. Salmeterol/fluticasone propionate should be discontinued immediately, the patient assessed, and alternative therapy instituted if necessary. 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 micrograms 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 treatment should be considered during periods of stress or elective surgery. Medicinal product no longer authorised 6 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 […]