Loading…
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: • patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled…
Verbatim from this product's MHRA label. Tap a section to expand.
Route of administration For inhalation use. Posology Asthma The dosage of the components 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 products is initiated but also when the maintenance dose is adjusted.
It is recommended that all patients with asthma are provided with a written personal asthma action plan. 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.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be regularly reassessed by their prescriber/health care provider so that the usage of BiResp Spiromax remains optimal.
When a new treatment is initiated or treatment dose adjusted, patients should be assessed more frequently.
For BiResp Spiromax there are three treatment approaches:
A.
BiResp Spiromax maintenance therapy:
BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue . B.
BiResp Spiromax maintenance and reliever therapy:
BiResp Spiromax is taken as regular maintenance treatment and as needed in response to symptoms. C.
BiResp Spiromax reliever therapy:
BiResp Spiromax is taken as needed in response to symptoms. A. BiResp Spiromax maintenance therapy Patients should be advised to have their separate rapid-acting bronchodilator 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 - 17 years): 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.
Since BiResp Spiromax contains both budesonide and formoterol, the same pattern of undesirable effects 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 drug related adverse reactions are pharmacologically predictable side effects of β2 adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.
Adverse reactions, which have been associated with budesonide or formoterol, are given below, 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) and very rare (<1/10,000).
g. g. atrial fibrillation, supraventricular tachycardia, extrasystoles Cardiac disorders Very rare Angina pectoris. Prolongation of QTc-interval Vascular disorders Very rare Variations in blood pressure Common Mild irritation in the throat, coughing, dysphonia including hoarseness Respiratory, thoracic and mediastinal disorders Rare 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 drug deposition.
Advising the patient to rinse the mouth out with water after each maintenance 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. As with other inhalation therapy, 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 Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of BiResp Spiromax. Regular review of patients as treatment is stepped down is important. 2). Patients should be advised to have their rescue inhaler available at all times, either a separate rapid-acting bronchodilator (for all patients using BiResp Spiromax as maintenance therapy only (therapy A)) or BiResp Spiromax (for asthma patients using BiResp Spiromax as maintenance and reliever therapy (therapy B)) and BiResp Spiromax as reliever therapy (therapy C)).
If patients take BiResp Spiromax as maintenance (therapy A or B), they should be reminded to take their BiResp Spiromax maintenance dose as prescribed, even when asymptomatic. 8), the patient should be instructed to rinse their mouth out with water after inhaling the maintenance dose.
If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. It is recommended that the maintenance dose is tapered when the treatment is discontinued and the dosing should not be stopped abruptly.
Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma. Deterioration of disease Serious asthma-related adverse events 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. 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.
1 (lactose, which contains small amounts of milk proteins).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
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.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Children (6 years and older):
A lower strength of budesonide/ formoterol inhaler (100 micrograms/6 micrograms/inhalation) is available for children 6-11 years.
Children under 6 years:
As only limited data are available, BiResp Spiromax is not recommended for children younger than 6 years. B. 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 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 reliever medication.
• asthma exacerbations in the past requiring medical intervention. Close monitoring for dose-related adverse effects 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.
Children under 12 years:
BiResp Spiromax maintenance and reliever therapy is not recommended for children. C. BiResp Spiromax reliever therapy Mild asthma patients take BiResp Spiromax as needed in response to symptoms. This will provide relief by the rapid acting bronchodilation and also reduce inflammation.
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 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.
Recommended doses:
Adults and adolescents (12 years and older): Patients should take 1 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.
4). A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 […]
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 prolonged 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.
4). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 BiResp Spiromax 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 HPA axis function should be monitored regularly. During transfer from oral therapy to BiResp Spiromax, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases, a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Excipients BiResp Spiromax contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 5). If this is not possible the time interval between administration of the interacting drugs should be as long as possible.
In patients using potent CYP3A4 inhibitors, BiResp Spiromax maintenance and reliever therapy is not recommended. Caution with special diseases BiResp Spiromax should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.
Caution should be observed when treating patients with prolongation of the QTc- interval. Formoterol itself may induce prolongation of the QTc-interval. Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
g. xanthine derivatives, steroids and diuretics, may add to a possible hypokalaemic effect of the β2 adrenoceptor agonist. Particular caution is recommended in unstable asthma with variable use of rescue bronchodilators, in acute severe asthma as the associated risk may be augmented by hypoxia and in other conditions when the likelihood for hypokalaemia is increased.
It is recommended that serum potassium levels are monitored during these circumstances. As for all β2 adrenoceptor agonists, additional blood glucose controls should be considered in diabetic patients. The need for, and dose of inhaled corticosteroids should be re-evaluated in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
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.
[…]