Budetide0.5 mg/2 ml

Budetide 0.5 mg/2 ml 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. Budetide 0.5 mg/2 ml inhaler is not indicated for the relief of acute bronchospasm.

Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids

Budetide 0.5 mg/2 ml 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 Budetide 0.5 mg/2 ml contribute to its efficacy in asthma.

Budetide 0.5 mg/2 ml inhaler should be administered by the orally inhaled route in asthmatic patients age 6 years and older. Individual patients will experience a variable onset and degree of symptom relief. Generally, Budetide 0.5 mg/2 ml inhaler has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of Budetide 0.5 mg/2 ml inhaler can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The safety and efficacy of Budetide 0.5 mg/2 ml inhaler, when administered in excess of recommended doses, have not been established.Adult: Bronchodilators alone- Recommended starting dose: 200 to 400 mcg twice daily Highest recommended dose: 400 mcg twice daily Adult: Inhaled corticosteroids**- Recommended starting dose: 200 to 400 mcg twice daily Highest recommended dose: 800 mcg twice daily Adult: Oral corticosteroids- Recommended starting dose: 400 to 800 mcg twice daily Highest recommended dose: 800 mcg twice daily Children: Bronchodilators alone- Recommended starting dose: 200 mcg twice daily Highest recommended dose: 400 mcg twice daily Children: Inhaled corticosteroids**- Recommended starting dose: 200 to 400 mcg twice daily Highest recommended dose: 400 mcg twice daily Children: Oral corticosteroids- Recommended dose: The highest recommended dose in children is 400 mg twice daily **In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Budetide 0.5 mg/2 ml inhaler 200 mg or 400 mg once daily may be considered. Budetide 0.5 mg/2 ml inhaler can be administered once daily either in the morning or in the evening.If the once daily treatment with Budetide 0.5 mg/2 ml inhaler does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered in divided doses.Patients maintained on chronic oral corticosteroids: Initially, Budetide 0.5 mg/2 ml inhaler should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrement should not exceed 2.5 mg of Prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Budetide 0.5 mg/2 ml Inhaler but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid dose should be increased temporarily and thereafter withdrawal should be continued more slowly. During periods of stress or a severe asthma attack, transferred patients may require supplementary treatment with systemic corticosteroids.

Budetide 0.5 mg/2 ml inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to Budetide 0.5 mg/2 ml contraindicates the use of Budetide 0.5 mg/2 ml inhaler.

The following adverse reactions were reported in patients treated with Budetide 0.5 mg/2 ml 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. Budetide 0.5 mg/2 ml 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 Budetide 0.5 mg/2 ml is absorbed into the circulation and can be systemically active at higher doses, the full beneficial effects of Budetide 0.5 mg/2 ml 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 Budetide 0.5 mg/2 ml inhaler.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

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