Active Substance: Budesonide, Formoterol fumarate dihydrate.
Overview
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This medicine contains an important and useful components, as it consists of
Budesonide, Formoterol fumarate dihydrateis available in the market in concentration
Budesonide + Formoterol Fumarate
Treatment with Budesonide and Formoterol combination should not be initiated to treat a severe exacerbation or if patients have significantly worsening or acutely deteriorating asthma. May produce paradoxical bronchospasm which is life-threatening. Caution when used in patients with CV diseases, especially coronary insufficiency, cardiac arrhythmias and hypertension. Chronic use may further decrease bone mineral content when used in patients with advanced age, osteoporosis, poor nutrition, sedentary lifestyle or tobacco use. May reduce growth velocity when used in paediatric patients. Caution when used in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections, or ocular herpes simplex. Pregnancy and lactation. Lactation: No data; weigh risks of therapy against benefits, and either discontinue drug or do not nurse
Asthma, COPD
Primary treatment of status asthmaticus or other acute episodes of asthma. Hypersensitivity to Budesonide, Formoterol or to Lactose.
>10% Upper respiratory tract infection (URTI) (8-11%),Headache (7-11%),Nasopharyngitis (7-11%) 1-10% Pharyngolaryngeal pain (6-9%),Stomach discomfort (1-7%),Sinusitis (5-6%),Oral candidiasis (1-6%),Bronchitis (5%),Viral URTI (4%),Backache (2-3%),Influenza (2-3%),Nasal congestion (2-3%),Vomiting (1- 3%)
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Budesonide is a corticosteroid that has mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein syntheis, decreasing the migration of polymorphonuclear leucocytes/fibroblasts and reversing capillary permeability. Formoterol fumarate is a selective beta2-adrenergic agonist. It causes bronchodilation by catalysing the conversion of adenosine triphosphate to cyclic-3', 5'-adenosine monophosphate (cyclic AMP) resulting in bronchial smooth muscle relaxation.
Concomitant admin with CYP3A4 inhibitor e.g. itraconazole, clarithromycin, erythromycin may inhibit the metabolism of budesonide. Concurrent use with nonpotassium-sparing diuretics may lead to ECG changes and/or hypokalaemia.
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