Budecort

Budecort

budesonide

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
Turbuhaler: Bronchial asthma. Respules: Bronchial asthma requiring treatment w/ glucocorticosteroids for control of the underlying airway inflammation for maintenance treatment & acute exacerbations. Exacerbations of COPD. Croup (acute viral URTI also known as viral laryngotracheobronchitis or laryngitis subglottica) in infants & childn.
Dosage/Direction for Use
Turbuhaler Individualized dosage. Adult 200-800 mcg/day, divided into 2-4 inhalations. More severe cases Up to 1,600 mcg. Full dose may be given in 1 administration w/ daily doses up to 400 mcg. Childn ≥6 yr 100-800 mcg/day, divided into 2-4 inhalations. Full dose may be given in 1 administration w/ daily doses up to 400 mcg. Respules Bronchial asthma Individualized dosage. Administration can be once daily or bid. Once daily administration can be used for 250-1,000 mcg once daily. Adult & elderly Initially, 1,000-2,000 mcg daily. Maintenance: 500-4,000 mcg daily, may be further increased in very severe cases. Childn ≥6 mth 250-500 mcg daily. Maintenance: 250-2,000 mcg daily. Adult & ped Consider once daily dosing in non-corticosteroid treated patient & patient well-controlled by inhaled glucocorticosteroids. Maintenance: 250-1,000 mcg once daily. Croup Child & infant 2 mg as a single dose or 1 mg in 2 divided doses separated by 30 min, can be repeated every 12-36 hr.
Contraindications
Special Precautions
Rinse mouth w/ water after each dose in order to minimise risk of candida infections in the oral cavity & throat, or after inhaling prescribed dose to minimise risk of oropharyngeal thrush. Avoid concomitant treatment w/ ketoconazole, itraconazole or other potent CYP3A4 inhibitors. Risk of impaired adrenal function in patients transferring from oral steroids, who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids; consider additional systemic corticosteroid cover during periods of stress or elective surgery as these patients may exhibit signs & symptoms of adrenal insufficiency when exposed to severe stress. Previous symptoms or feeling unwell in non-specific way eg, muscle & joint pain may return during transfer from oral steroid therapy to budesonide or w/drawal phase; increased oral steroid/glucocorticosteroids dose may be necessary. Allergies eg, rhinitis & eczema previously controlled by systemic treatment/drug may be revealed/unmasked during replacement of systemic steroid treatment by budesonide or w/ inhaled therapy. Regular & close monitoring of growth in childn & adolescents receiving long-term treatment w/ corticosteroids. Pregnancy. Turbuhaler: Patients transferred from systemically acting corticosteroids to budesonide & in cases of suspected disturbance of pituitary-adrenocortical function; consider cautious systemic steroid dose reduction, & hypothalamic-pituitary-adrenocortical function tests; & adjunct of systemic steroids in connection w/ periods of stress eg, surgery, trauma. Supplement w/ short-course of oral steroids if there is a sudden treatment deterioration. Patients w/ impaired hepatic or renal function. Patients w/ severe cirrhosis of the liver. Lactation. Respules: Not intended for rapid relief of acute episodes of asthma where an inhaled short-acting bronchodilator is required. Consider a need for increased anti-inflammatory therapy eg, higher doses of inhaled budesonide or course of oral glucocorticosteroid if short-acting bronchodilator treatment is ineffective, or more inhalations are needed than usual. Patients w/ severely compromised liver function.
Adverse Reactions
Mild irritation in the throat, candida infection in the oropharynx, hoarseness, coughing.
Drug Interactions
Increased plasma conc/levels or systemic exposure w/ potent CYP3A4 inhibitors eg, ketoconazole & itraconazole.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
Presentation/Packing
Form
Budecort respules 250 mcg/mL
Packing/Price
2 mL x 20 × 1's
Form
Budecort respules 500 mcg/mL
Packing/Price
2 mL x 20 × 1's
Form
Budecort turbuhaler 200 mcg/dose
Packing/Price
100 dose x 1's
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