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Brand of Budesonide
GoResp Digihaler (Previously Budesonide/Formoterol Teva Pharma B.V.) is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GoResp Digihaler is indicated in adults 18 years of age and older only. Asthma GoResp Digihaler 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…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Asthma This medicinal product is not intended for the initial management of asthma. Budesonide/formoterol fumarate dihydrate is not an appropriate treatment for adult patients with only mild asthma. The dose of this medicinal product 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 requires 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 budesonide/formoterol fumarate dihydrate. Patients should be reassessed regularly by their physician/healthcare provider so that the dose of this medicinal product 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 GoResp Digihaler, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate dihydrate 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 physician, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
For GoResp Digihaler there are two treatment approaches: maintenance therapy, and maintenance and reliever therapy. Maintenance therapy GoResp Digihaler is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.
Summary of the safety profile Since this medicinal product 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.
Common adverse reactions mainly attributed to β2 adrenoceptor agonist therapy are tremor and palpitations. Common adverse reactions mainly attributed to corticosteroid therapy are candida infections in the oropharynx, pneumonia, mild irritation in the throat, coughing, and dysphonia including hoarseness.
A common adverse reaction that can be contributed to both budesonide and formoterol is headache. 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 (see table 1).
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). g. g. 4 for more information 2Adverse reaction mainly attributed to budesonide 3Adverse reaction mainly attributed to formoterol Description of selected adverse reactions Systemic effects 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. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Dosing advice Patients should be reassessed regularly by their physician/healthcare provider so that the dose of GoResp Digihaler 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 this treatment. When it is appropriate to titrate down to a lower strength than is available for GoResp Digihaler, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate dihydrate 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 GoResp Digihaler (for asthma patients using this medicinal product as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using this medicinal product 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 medicinal product maintenance dose as prescribed, even when asymptomatic. g. before exercise, has not been studied. g. before exercise. Deterioration of disease This medicinal product should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required.
Patients should not be initiated on this medicinal product during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. 8). Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with this medicinal product.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times. The recommended dose for adults (18 years of age and older) is 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. Maintenance and reliever therapy GoResp Digihaler is taken as regular maintenance treatment and as needed in response to symptoms.
Patients take a daily maintenance dose of GoResp Digihaler and in addition take this medicinal product as needed in response to symptoms. Patients should be advised to always have GoResp Digihaler available for rescue use. 4 For patients taking GoResp Digihaler as reliever, preventative use of this medicinal product 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. Budesonide/formoterol fumarate dihydrate 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 this medicinal product as-needed inhalations. The recommended maintenance dose for adults (18 years of age and older) 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 The recommended dose for adults (18 years of age and older) is 2 inhalations twice daily. Special populations Elderly patients There are no dose adjustments required for elderly patients.
Renal impairment There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with renal impairment. 2). Hepatic impairment There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic impairment.
As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis. 2). Paediatric population The safety and efficacy of this medicinal product in children aged 12 years and younger and adolescents aged 13 to 17 years has not yet been established.
2 but no recommendation on a posology can be made. This medicinal product is not recommended for use in children and adolescents under the age of 18 years. 5 Method of administration For inhalation use only. Digihaler is a breath actuated, inspiratory flow-driven […]
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.
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). 8). 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.
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. 8). 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.
8). 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 bronchopasm, treatment with this medicinal product should be discontinued 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 […]