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Symbicort Turbuhaler信必可

Symbicort Turbuhaler

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per 80/4.5 mcg turbuhaler Budesonide 80 mcg, formoterol 4.5 mcg. Per 160/4.5 mcg turbuhaler Budesonide 160 mcg, formoterol 4.5 mcg. Per 320/9 mcg turbuhaler Budesonide 320 mcg, formoterol 9 mcg
Indications/Uses
80/4.5 mcg Regular treatment of asthma in adults, adolescents & childn ≥6 yr where combination therapy w/ inhaled corticosteroid & long-acting β2-agonist is appropriate. 160/4.5 mcg Treatment of asthma in adults & adolescents ≥12 yr to achieve overall asthma control, including symptomatic relief & risk reduction of exacerbations: Anti-inflammatory reliever therapy in patients w/ mild disease; anti-inflammatory reliever + maintenance therapy; maintenance therapy (fixed dose). Symptomatic treatment of moderate to severe COPD (FEV1 ≤50% predicted normal) in adults w/ frequent symptoms despite long-acting bronchodilator use, &/or a history of recurrent exacerbations. 320/9 mcg Regular treatment of asthma in adults & adolescents 12-17 yr where combination therapy w/ inhaled corticosteroid & long-acting β2-agonist is appropriate. Symptomatic treatment of COPD patients w/ FEV1 <70% predicted normal (post-bronchodilator) & an exacerbation history despite regular bronchodilator therapy.
Dosage/Direction for Use
80/4.5 mcg turbuhaler Asthma, maintenance therapy Adult ≥18 yr 1-2 inhalations bd. Max: 4 inhalations bd. Adolescent 12-17 yr 1-2 inhalations bd. Childn ≥6 yr 2 inhalations bd. Asthma, maintenance & reliever therapy Adult & adolescent ≥12 yr 1 inhalation bd or 2 inhalations in either morning or evening. Take 1 additional inhalation as needed. Max: 6 inhalations on a single occasion; 8 inhalations/day. 12 inhalations/day could be used for a limited period. 160/4.5 mcg turbuhaler Asthma anti-inflammatory reliever therapy in patients w/ mild disease Adult & adolescent ≥12 yr 1 inhalation as needed. Take 1 additional inhalation if symptoms persist after a few min. Do not take >6 inhalations on any single occasion. Total daily dose: Up to 12 inhalations can be used temporarily. Asthma anti-inflammatory reliever & maintenance therapy Adult & adolescent ≥12 yr Reliever therapy: 1 inhalation as needed. Take 1 additional inhalation if symptoms persist after a few min. Do not take >6 inhalations on any single occasion. Recommended maintenance dose: 2 inhalations daily (as 1 inhalation in the morning & evening or as 2 inhalations in either the morning or evening). 2 inhalations bd may be appropriate for some patients. Total daily dose: Up to 12 inhalations can be used temporarily. Asthma maintenance therapy (fixed dose) Adult & adolescent ≥12 yr 1 or 2 inhalations bd. Max recommended daily dose: 4 inhalations. Titrate to lowest dose at which effective asthma control is maintained. COPD Adult 2 inhalations bd. Max recommended daily dose: 4 inhalations. 320/9 mcg turbuhaler Asthma, maintenance therapy Adult ≥18 yr 1 inhalation bd. Max: 2 inhalations bd. Adolescent 12-17 yr 1 inhalation bd. COPD Adult 1 inhalation bd.
Contraindications
Hypersensitivity to budesonide, formoterol, or lactose.
Special Precautions
Use for the shortest time required to achieve control of asthma symptoms. Long-term use may be considered only in patients whose asthma cannot be adequately controlled on asthma controller medications. Taper dose when discontinuing treatment. Take maintenance dose as prescribed even when asymptomatic. Rinse mouth w/ water after inhalations to minimise risk of oropharyngeal thrush. Do not use to initiate treatment w/ inhaled steroids in patients being transferred from oral steroids. Potential systemic effects of inhaled corticosteroids eg, HPA axis depression/adrenal insufficiency, bone density reduction, cataract & glaucoma, & growth rate retardation in childn & adolescents. Signs of existing infection may be masked by high-dose glucocorticosteroid use & new infections may appear during use. Consider arrhythmogenic potential of β2-agonists before commencing treatment for bronchospasm. Patients w/ pre-existing CV conditions may be at greater risk of developing adverse CV effects following administration. High doses of β2-agonists can result to potentially serious hypokalaemia. Blood-glucose increasing effects of β2-stimulants; extra blood glucose controls are recommended in DM patients. Possible development of pneumonia in patients w/ COPD. Patients w/ active or quiescent pulmonary TB or fungal, bacterial or viral resp infections. Patients w/ increased susceptibility to sympathomimetic amines (eg, inadequately controlled hyperthyroidism). Patients w/ severe CV disorders eg, ischaemic heart disease, tachyarrhythmias or severe heart failure. Patients w/ renal or hepatic impairment. Pregnancy & lactation. 160/4.5 mcg & 320/9 mcg Not recommended for childn <12 yr.
Adverse Reactions
Palpitations; oropharyngeal candidiasis, pneumonia in COPD patients; headache, tremor; mild throat irritation, cough, hoarseness.
Drug Interactions
Potent CYP3A4 inhibitors may increase systemic exposure to budesonide. Formoterol: Inhibited effect & increased airway resistance w/ β-blockers. Cumulative effect w/ other β-adrenergic stimulants or sympathomimetic amines (eg, ephedrine). Potentiated hypokalaemia w/ xanthine derivatives, mineralocorticosteroids, & diuretics. Adverse CV effects may be exacerbated by concurrent administration of drugs associated w/ QT interval prolongation & increased risk of ventricular arrhythmia (eg, MAOIs, TCAs, quinidine, disopyramide, procainamide, phenothiazines or antihistamines eg, terfenadine, astemizole).
ATC Classification
R03AK - Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics ; Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Symbicort Turbuhaler 160/4.5 mcg turbuhaler
Packing/Price
60 dose x 1's
Form
Symbicort Turbuhaler 320/9 mcg turbuhaler
Packing/Price
60 dose x 1's
Form
Symbicort Turbuhaler 80/4.5 mcg turbuhaler
Packing/Price
60 dose x 1's
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