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Vylaer Spiromax is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vylaer Spiromax is indicated in adults 18 years of age and older only. Asthma Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids…
Verbatim from this product's EMA label. Tap a section to expand.
Vylaer Spiromax is indicated in adults 18 years of age and older only. Vylaer Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. Posology Asthma Vylaer Spiromax is not intended for the initial management of asthma.
Vylaer Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists. The dosage of Vylaer Spiromax is individual and should be adjusted to the severity of the disease.
This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Vylaer Spiromax. Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Vylaer Spiromax remains optimal.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When it is appropriate to titrate down to a lower strength than is available for Vylaer Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone. In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the prescriber, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
Vylaer Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler. Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
Summary of safety profile Since Vylaer Spiromax contains both budesonide and formoterol, the same pattern of adverse reactions as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. 01, respectively).
2). Tabulated list of adverse reactions Adverse reactions, which have been associated with budesonide or formoterol, are given below and listed by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
g. g. atrial fibrillation, supraventricular tachycardia, extrasystoles Very rare Angina pectoris. Prolongation of QTc-interval Vascular disorders Very rare Variations in blood pressure Respiratory, thoracic and mediastinal disorders Common Mild irritation in the throat, coughing, hoarseness Rare Bronchospasm Very rare Paradoxical bronchospasm Gastrointestinal disorders Uncommon Nausea Skin and subcutaneous tissue disorders Uncommon Bruises Musculoskeletal and connective tissue disorders Uncommon Muscle cramps Description of selected adverse reactions Candida infection in the oropharynx is due to active substance deposition.
Advising the patient to rinse the mouth out with water after each dose will minimise the risk. Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.
Paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchopasm responds to a rapid-Medicinal product no longer authorised 11 acting inhaled bronchodilator and should be treated straightaway.
General It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. 2). Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment.
g. a course of oral corticosteroids, or antibiotic treatment if an infection is present. Patients should be advised to have their rescue inhaler available at all times. Patients should be reminded to take their Vylaer Spiromax maintenance dose as prescribed, even when asymptomatic.
g. before exercise, has not been studied. A separate rapid-acting bronchodilator should be considered for such prophylactic use. Asthma symptoms Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of Vylaer Spiromax remains optimal.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Vylaer Spiromax. When it is appropriate to titrate down to a lower strength than is available for Vylaer Spiromax, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Regular review of patients as treatment is stepped down is important. Patients should not be initiated on Vylaer Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse reactions and exacerbations may occur during treatment with Vylaer Spiromax.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Vylaer Spiromax. Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in European Union.
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Recommended doses:
Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
Medicinal product no longer authorised 4 COPD Recommended doses:
Adults (18 years and older): 2 inhalations twice daily.
Special populations:
Elderly patients (≥65 years old) There are no special dosing requirements for elderly patients. Patients with renal or hepatic impairment There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment.
As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis. Paediatric population The safety and efficacy of Vylaer Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
No data are available. This medicinal product is not recommended for use in children and adolescents under the age of 18 years. Method of administration Inhalation use. Spiromax 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). Vylaer 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.
The use of Vylaer 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:
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 from 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. It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax and not to block the air vents when they are preparing the “Breathe” step.
Medicinal product no longer authorised 5
4). Systemic effects of inhaled corticosteroids may occur, 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 and glaucoma.
Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur. Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity. Treatment with β2 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
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.
If the patient experiences paradoxical bronchopasm Vylaer Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary. 8). Systemic effects Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
8). It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid to the lowest dose at which effective control of asthma is maintained, if possible.
The benefits of the corticosteroid therapy and the possible risks of growth suppression must be carefully weighed. In addition consideration should be given to referring the patient to a paediatric respiratory specialist. Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height.
However, an initial small but transient reduction in growth (approximately 1 cm) has been observed. This generally occurs within the first year of treatment. Effects on bone density Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.
Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.
No information regarding the effect of a budesonide/formoterol fumarate dihydrate fixed-dose combination at higher doses is available. Adrenal function If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to a budesonide/formoterol fumarate fixed-dose combination therapy.
The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time.
In such circumstances hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly. High dose corticosteroids The prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.
Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Rapid reduction in the dose of steroids can induce acute adrenal crisis. Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, […]