Budesonide/Formoterol
Regulatory sources consulted
- EMA/H/C/004882
- AEMPS-CIMA-78813
- https://www.ema.europa.eu/en/medicines/human/EPAR/goresp-digihaler-previously-budesonide-formoterol-teva-pharma-b-v
- https://cima.aemps.es/cima/dochtml/ft/78813/FT_78813.html
- CredibleMeds.org
- AEMPS CIMA · nº registro 78813 ↗
- EMA EPAR · EMEA/H/C/004882 ↗
- RxNorm rxcui 389132 ↗
Approved indications
- Regular treatment of asthma in adults (18 years of age and older), 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 short-acting β2 adrenoceptor agonists, or in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
- Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Contraindications
Absolute
- Hypersensitivity to the active substances or to any of the excipients (e.g., lactose, which contains small amounts of milk proteins).
Relative
- Not indicated for the primary treatment of status asthmaticus or other acute episodes of asthma or COPD.
Clinical warnings
- Major warning · An increased risk of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. — EMA
- Major warning · As with other inhalation therapies, paradoxical bronchospasm may occur. If it occurs, treatment should be discontinued immediately and alternative therapy instituted. — EMA
- 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, adrenal suppression, growth retardation in children and adolescents, and decrease in bone mineral density. — EMA
Drug interactions
- HighKetoconazoleJ02AB02
Mechanism: Potent inhibition of CYP3A4, significantly increasing plasma levels of budesonide.
Recommendation: Avoid co-administration. If unavoidable, the interval between administration of the drugs should be as long as possible and a reduction of the budesonide dose may be considered.
EMA SPC
- HighPropranololC07AA05
Mechanism: Beta-adrenergic blockers (including eye drops) can partially or totally antagonize the effect of formoterol.
Recommendation: Avoid use of non-selective beta-blockers. If required, use cardioselective beta-blockers with caution.
EMA SPC
Adverse events
Common (≥1%)
oropharyngeal candidiasis · headache · tremor · palpitations · hoarseness · cough · throat irritation
Rare but serious
pneumonia (in COPD patients) · paradoxical bronchospasm · hypersensitivity reactions · cardiac arrhythmias · adrenal suppression · glaucoma · cataracts
Pregnancy and lactation
Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Lactation: A decision must be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.