Symbicort Rapihaler

Symbicort Rapihaler

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 80/4.5 mcg/actuation Budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 160/4.5 mcg/actuation Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg
Indications/Uses
Regular treatment of asthma where use of combination (inhaled corticosteroid & long-acting β2-agonist) is appropriate. Symptomatic treatment of patients w/ COPD (FEV1 <70% predicted normal) & history of exacerbation despite regular bronchodilator therapy.
Dosage/Direction for Use
Asthma Adult ≥18 yr & adolescent 12-17 yr 2 inhalations once or bd, may be increased to max: 4 inhalations bd. Childn 6-11 yr 80/4.5 mcg 2 inhalations bd. Max: 4 inhalations daily. COPD Adult ≥18 yr 160/4.5 mcg 2 inhalations bd.
Special Precautions
Discontinue use if paradoxical bronchospasm occurs. Not to be initiated during exacerbation or in patients w/ significantly worsening or acutely deteriorating asthma. Active or quiescent pulmonary TB, fungal & viral airway infections. 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; severe CV disorders eg, ischaemic heart disease, tachyarrythmias or severe heart failure; QTc interval prolongation; visual disturbances. Pneumonia in patients w/ COPD. Risk of oropharyngeal candida infection. Monitor HPA axis function, K & blood glucose levels. Transferring patients from previous systemic steroid therapy. Avoid abrupt w/drawal. High-dose & prolonged use. Avoid concomitant treatment w/ itraconazole, ritonavir or potent CYP3A4 inhibitors. Concomitant use w/ xanthine derivative, steroids, diuretics. Pregnancy & lactation. Childn ≤11 yr or adolescents 12-17 yr w/ COPD; growth retardation in childn & adolescents.
Adverse Reactions
Palpitations; oropharyngeal candida infections, pneumonia (COPD patients); headache, tremor; mild throat irritation, coughing, 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 w/ 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 Rapihaler MDI 80/4.5 mcg/actuation
Packing/Price
120 actuation x 1's
Form
Symbicort Rapihaler MDI 160/4.5 mcg/actuation
Packing/Price
120 actuation x 1's
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