Symbicort Rapihaler

Symbicort Rapihaler

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 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-adrenoceptor agonist) is appropriate. Symptomatic treatment of patients w/ moderate to severe COPD & history of exacerbations.
Dosage/Direction for Use
Asthma Individualized dose. Adult ≥18 yr & adolescent 12-17 yr 2 actuations once daily or bid, may be increased to max: 4 actuations bid. COPD Adult ≥18 yr 2 actuations bid. Max daily dose: 4 actuations.
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. Adrenal suppression, decreased bone mineral density, cataract, glaucoma; periods of stress, 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 serum K & blood glucose levels. Transferring from previous systemic steroid therapy. Taper dose & avoid abrupt discontinuation. High-dose & prolonged use. Concomitant use w/ xanthine derivative, steroids, diuretics. Severe liver disease. Pregnancy & lactation. Not recommended for childn <6 yr. Growth retardation in childn & adolescents.
Adverse Reactions
Headache, tremor; palpitations; oropharynx candida infections, pneumonia (in COPD); throat mild irritation, coughing, hoarseness.
Drug Interactions
Increased budesonide systemic exposure w/ potent CYP3A4 inhibitors. 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, MAOIs & 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 effect w/ other β-adrenergic drugs. Hypokalaemia w/ digitalis glycosides.
MIMS Class
Antiasthmatic & COPD Preparations
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 160/4.5 mcg/actuation
Packing/Price
120 actuation x 1's
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