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BiResp Spiromax is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Asthma BiResp Spiromax is indicated in adults and adolescents (12 years and older) for 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 and “as needed” inhaled…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Asthma BiResp Spiromax is not intended for the initial management of asthma. 3 BiResp Spiromax is not an appropriate treatment for the adult or adolescent patient with only mild asthma. The dosage of BiResp 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 BiResp Spiromax. Patients should be reassessed regularly by their prescriber/health care provider so that the dose of BiResp 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 BiResp 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.
For BiResp Spiromax there are two treatment approaches:
BiResp Spiromax maintenance therapy: BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
BiResp Spiromax maintenance and reliever therapy:
BiResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms. BiResp Spiromax maintenance therapy Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
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. Adolescents (12 years and older): 1-2 inhalations twice daily. In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include BiResp Spiromax given once daily, when in the opinion of the prescriber, a long-acting bronchodilator in combination with an inhaled corticosteroid would be required to maintain control.
Summary of the safety profile Since BiResp 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).
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, Dysphonia including 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.
If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. 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.
Dosing advice Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of BiResp 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 BiResp Spiromax. When it is appropriate to titrate down to a lower strength than is available for BiResp 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 be advised to have their rescue inhaler available at all times, either BiResp Spiromax (for asthma patients using BiResp Spiromax as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using BiResp Spiromax as maintenance therapy only).
It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma.
Patients should be reminded to take their BiResp Spiromax maintenance dose as prescribed, even when asymptomatic. g. before exercise, has not been studied. g. before exercise. In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used.
Deterioration of disease 6 Serious asthma-related adverse reactions and exacerbations may occur during treatment with BiResp Spiromax. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with BiResp Spiromax.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. BiResp Spiromax maintenance and reliever therapy Patients take a daily maintenance dose of BiResp Spiromax and in addition take BiResp Spiromax as needed in response to symptoms.
Patients should be advised to always have BiResp Spiromax available for rescue use. For patients taking BiResp Spiromax as reliever, preventative use of BiResp Spiromax for allergen- or exercise-induced bronchoconstriction should be discussed between physician and patient; the recommended 4 use should take into consideration the frequency of need.
In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used. BiResp Spiromax maintenance and reliever therapy should especially be considered for patients with: • inadequate asthma control and in frequent need of a reliever inhaler.
• asthma exacerbations in the past requiring medical intervention. Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of BiResp Spiromax as-needed inhalations.
Recommended doses:
Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate.
Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.
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 BiResp Spiromax in paediatric patients below 12 years of age have not been established.
No data are available. This medicinal product is not recommended for use in children under the age of 12 years. Method of administration For inhalation use only. 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). BiResp Spiromax should be used correctly in order to achieve effective treatment. As such, the patients should be advised to read the patient information leaflet […]
Paradoxical bronchospasm responds to a rapid- acting inhaled bronchodilator and should be treated straightaway. 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 12 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.
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 not be initiated on BiResp Spiromax during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. 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 with inhalation treatment than with oral corticosteroids. 8). 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.
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 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 Treatment with supplementary systematic steroids or inhaled budesonide should not be stopped abruptly.
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, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.
Paradoxical bronchospasm Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing. If the patient experiences paradoxical bronchospasm BiResp Spiromax should be discontinued 7 immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
8). Transfer from oral therapy 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 […]