Budesonide (Inhaler)

N/A

Budesonide inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their ... Read moreBudesonide inhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Budesonide inhaler is not indicated for the relief of acute bronchospasm.

N/A

Budesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to Budesonide contraindicates the use of Budesonide inhaler.

Budesonide inhaler is a corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, oeosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and non-allergic inflammation. These anti-inflammatory actions of Budesonide contribute to its efficacy in asthma.

The following adverse reactions were reported in patients treated with Budesonide inhaler. General: Headache, flu-like syndrome, pain, back pain, fever, neck pain, asthenia. Respiratory system: Respiratory tract infections, pharyngitis, sinusitis, rhinitis, voice alteration, cough aggravation. Digestive system: Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth, vomiting. Metabolic and Nutritional: Weight gain. Musculoskeletal: Fracture, myalgia, arthralgia. Nervous system: Syncope, hypertonia, migraine. Skin: Ecchymosis. Psychiatric: Insomnia. Resistance Mechanisms: Infection. Special Senses: Taste perversion.

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. Budesonide inhaler will often permit control of asthma symptoms with less suppression of hypothalamic-pituitary-adrenal (HPA) function than therapeutically equivalent oral doses of Prednisone. Since Budesonide is absorbed into the circulation and can be systemically active at higher doses, the full beneficial effects of Budesonide inhaler in minimising HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this fact when prescribing Budesonide inhaler.

Paediatric studies: There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.