Budesonidum et Formoterolum
Description
An inhaled medicine containing the corticosteroid budesonide and the fast-acting and long-acting selective β2 adrenomimetic formoterol fumarate dihydrate.
Indications
Asthma: for regular long-term treatment of asthma, to achieve and maintain control when treatment with a combination of corticosteroid and long-acting β2 adrenoceptor agonist is needed. Chronic obstructive pulmonary disease: for the treatment of severe COPD (when FEV1 is less than 50% of normal) that exacerbates repeatedly, and significant symptoms persist despite regular use of long-acting bronchodilators.
Contraindications
Hypersensitivity to budesonide, formoterol, and/or any excipient.
Dosage
Adults. Pulv. pro inh. Asthma. Usual dose: 160 μg budesonide and 4.5 μg formoterol twice daily. The dose is selected based on the severity of the disease and its control, later reduced to the minimum effective dose. If asthma control is inadequate, the dose may be increased to 320 μg budesonide and 9 μg formoterol twice daily. Some patients may require doubling the dose. Chronic obstructive pulmonary disease. Usual dose: 320 μg budesonide and 9 μg formoterol twice daily.
Children. Pulv. pro inh. Budesonide and formoterol mixture is not recommended for children under 6 years old. For children aged 6-12 years: 80-160 micrograms of budesonide and 4.5 micrograms of formoterol mixture twice daily. For adolescents aged 12-17 years: 80-160 micrograms of budesonide and 4.5 micrograms of formoterol 1-2 times daily.
PK. Most budesonide and formoterol are eliminated during metabolism in the liver, therefore drug accumulation is expected in severe liver cirrhosis. However, there is no data on the use in patients with liver failure.
Adverse reactions
Allergic reactions.
Most common: increased heart rate, oral and throat candidiasis, headache, tremor, mild throat irritation, cough, wheezing.
Others: atrial fibrillation, supraventricular tachycardia, extrasystoles, nausea, hypokalemia, palpitations, dizziness, psychomotor agitation, nervousness, sleep disturbances, hemorrhages, paradoxical bronchospasm, allergic reactions. Very rarely – angina pectoris, hyperglycemia, taste disturbances, depression, behavioral disorders (mostly in children), hypotension. Possible systemic effects of corticosteroids: adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma.
Pregnancy
There are no clinical data on the combined use of formoterol and budesonide during pregnancy. Pregnant women should only be given the drug if the expected therapeutic effect outweighs the potential risk. A minimal dose of budesonide should be administered to maintain effective control of bronchial asthma.
Breastfeeding
Budesonide is excreted in breast milk. However, when taken at therapeutic doses, no effect on the breastfed infant is expected. It is unknown whether formoterol is excreted in breast milk. A small amount of formoterol has been found in the breast milk of lactating rats. Breastfeeding women may be advised to use the drug only if the expected therapeutic effect for the mother outweighs the potential risk to the infant.
Warnings
The drug should not be abruptly discontinued, the dose should be reduced gradually. After each inhalation of the drug, rinse the mouth with water. Caution should be exercised when prescribing this drug to patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncorrected hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic hypertrophic subaortic stenosis, severe hypertension, aneurysm, severe ischemic heart disease, tachyarrhythmia, severe heart failure, prolonged corrected QT interval. If active or latent pulmonary tuberculosis, fungal or viral respiratory tract infection is diagnosed in a patient, the need for inhaled corticosteroid therapy and its dose should be reconsidered. When using cardiac glycosides, the risk of arrhythmias may increase due to hypokalemia.
Source | Drug Guide | Lithuanian University of Health Sciences | Institute of Physiology and Pharmacology | Doctor of Medical Sciences Rimas Jankūnas, Doctor of Medical Sciences Arvydas Milašius | Clinic of Internal Diseases | Doctor of Medical Sciences Palmira Leišytė