Symbicort Turbuhaler

Symbicort Turbuhaler

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 80/4.5 mcg/dose Budesonide 80 mcg, formoterol 4.5 mcg. Per 160/4.5 mcg/dose Budesonide 160 mcg, formoterol 4.5 mcg
Indications/Uses
Asthma including symptomatic relief & to reduce risk of exacerbations. Symptomatic treatment of patients w/ COPD (FEV1 <70% predicted normal) & history of exacerbation despite regular bronchodilator therapy.
Dosage/Direction for Use
Asthma Maintenance therapy Adult ≥18 yr 1-2 inhalations bd, may be increased up to max: 4 inhalations bd. Adolescent 12-17 yr 1-2 inhalations bd. Childn ≥6 yr 80/4.5 mcg 2 inhalations bd. Adult & adolescent ≥12 yr Maintenance therapy 2 inhalations daily either as 1 inhalation in the morning & evening, or 2 inhalations either morning or evening. Reliever therapy 1 additional inhalation as needed in response to symptoms. Not >6 inhalations on any single occasion. Max: >8 inhalations daily is not normally needed, but may use up to 12 inhalations daily temporarily. COPD Adult ≥18 yr 160/4.5 mcg 2 inhalations bd.
Contraindications
Hypersensitivity to budesonide, formoterol or lactose.
Special Precautions
Discontinue use if paradoxical bronchospasm occurs. Not to be initiated during exacerbation or in patients w/ significantly worsening or acutely deteriorating asthma. Allergic reactions. Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression; periods of stress eg, severe infections, elective surgery; thyrotoxicosis, phaeochromocytoma, DM, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm or other severe CV disorders eg, ischaemic heart disease, tachyarrhythmias or severe heart failure; QTc interval prolongation; active or quiescent pulmonary TB, fungal & viral airway infections; visual disturbances. Risk of oropharyngeal candida infection. Pneumonia in patients w/ COPD. Transferring patients from previous systemic steroid therapy. Monitor HPA axis function, serum K & blood glucose levels. Avoid abrupt w/drawal. High-dose & prolonged use. Lactose intolerance. Avoid concomitant use w/ itraconazole, ritonavir or potent CYP3A4 inhibitors. Concomitant use w/ xanthine derivatives, steroids, diuretics. Severe hepatic disease. Pregnancy & lactation. Growth retardation in childn & adolescents. Not recommended in childn <6 yr & as anti-inflammatory reliever therapy in childn <12 yr. 80/4.5 mcg: Not appropriate in patients w/ severe asthma.
Adverse Reactions
Palpitations; oropharyngeal candida infections, pneumonia (COPD patients); headache, tremor; mild throat irritation, cough, hoarseness.
Drug Interactions
Increased budesonide plasma levels w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, HIV PIs. Weakened or inhibited formoterol effect w/ β-adrenergic blockers including eye drops. Prolonged QTc interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines, TCAs. Impaired cardiac tolerance by l-dopa, l-thyroxine, oxytocin, alcohol. Precipitated hypertensive reactions w/ MAOIs including agents w/ similar properties eg, furazolidone, procarbazine. Elevated risk of arrhythmias w/ halogenated hydrocarbons. Additive bronchodilating effect w/ other β-adrenergic drugs. Hypokalaemia w/ digitalis glycosides. Potentiated hypokalaemia w/ xanthine derivatives, corticosteroids, diuretics.
ATC Classification
R03AK07 - formoterol and budesonide ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Symbicort Turbuhaler 160/4.5 mcg/dose turbuhaler
Packing/Price
120 dose x 1's;30 dose x 1's;60 dose x 1's
/malaysia/image/info/symbicort turbuhaler 160-4-5 mcg-dose turbuhaler/160-4-5 mcg-dose?id=6f441e97-d5c2-4688-b3cd-9faa000a42bb
/malaysia/image/info/symbicort turbuhaler 160-4-5 mcg-dose turbuhaler/160-4-5 mcg-dose?id=db04cfe2-8994-49b7-8e91-9faa000a428c
Form
Symbicort Turbuhaler 80/4.5 mcg/dose turbuhaler
Packing/Price
60 dose x 1's
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