Symbicort

Symbicort

budesonide + formoterol

Manufacturer:

AstraZeneca
Concise Prescribing Info
Contents
Per dose Symbicort 80/4.5 mcg turbuhaler Budesonide 80 mcg, formoterol fumarate 4.5 mcg. Per dose Symbicort 160/4.5 mcg turbuhaler Budesonide 160 mcg, formoterol fumarate 4.5 mcg
Indications/Uses
Regular treatment of asthma where use of a combination (inhaled corticosteroid & long-acting β2-agonist) is appropriate. Symptomatic treatment of severe COPD (FEV1 <50% predicted normal) & history of repeated exacerbations in patients w/ significant symptoms despite regular therapy w/ long-acting bronchodilators.
Dosage/Direction for Use
Asthma Individualized dosage. Maintenance & reliever therapy: Adult & adolescent ≥12 yr 2 inhalations daily of 80/4.5 mcg or 160/4.5 mcg given either as 1 inhalation in the morning & evening or 2 inhalations in either the morning or evening. 1 additional dose as needed for symptoms & 1 more if symptoms persist after a few min. Maintenance dose: 2 inhalations twice daily of 160/4.5 mcg. Max: 6 inhalations. Childn ≥6 yr 1 inhalation once daily of 80/4.5 mcg. Max: Not more than 4 inhalations. Maintenance therapy: Adult & adolescent ≥12 yr 1-2 inhalations twice daily of 80/4.5 mcg or 160/4.5 mcg. Childn ≥6 yr 2 inhalations daily of 80/4.5 mcg. COPD Adult 2 inhalations twice daily of 160/4.5 mcg.
Contraindications
Hypersensitivity to budesonide, formoterol or lactose (which contains small amounts of milk proteins).
Special Precautions
Not to be discontinued abruptly. Contact physician if patient finds treatment ineffective or max daily dose exceeded & consider need for increased therapy w/ corticosteroids. Rescue inhaler must be available at all times. Not to be initiated to treat severe exacerbations. Patients must take maintenance dose as prescribed, even when asymptomatic. Reliever inhalations are not intended for regular prophylactic use. Discontinue use if paradoxical bronchospasm occurs. Systemic effects may occur in high doses & long-term treatment eg, adrenal suppression, growth retardation in childn & adolescents, decrease in bone mineral density, cataracts, glaucoma. Regularly monitor height of childn receiving prolonged treatment. Initial small but temporary reduction in growth in childn & adolescents during 1st yr of treatment. Patients transferred from oral or systemic steroid therapy; who have required high dose emergency corticosteroid therapy in the past or had prolonged treatment w/ high dose of inhaled corticosteroids. Rinse mouth out after each inhalation to minimize risk of candida infection. Concomitant treatment w/ itraconazole, ritonavir & other potent CYP3A4 inhibitors; β2-agonists & drugs which can induce hypokalaemia eg, xanthine derivatives, steroids, duretics. Patients w/ thyrotoxicosis, phaeochromocytoma, DM, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic sub-valvular aortic stenosis, severe HTN, aneurysm or other severe heart disease, tachyarrhythmia or severe heart failure; prolongation of the QTc interval; active or quiescent pulmonary TB; fungal & viral infections in the airways. Monitor serum K levels. Additional blood glucose controls in diabetic patients. Contains lactose (<1 mg/inhalation) which amount does not normally cause problem in lactose intolerant people, but may cause allergic reactions. Increased risk of pneumonia. Pregnancy & lactation.
Adverse Reactions
Palpitations; oropharyngeal candida infection; headache, tremor; mild throat irritation, coughing, hoarseness.
Drug Interactions
Increased plasma levels of budesonide w/ CYP3A4 inhibitors eg, itraconazole, ritonavir. β-adrenergic blockers can weaken or inhibit effects of formoterol. Quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), MAOIs & TCAs can prolong the QTc-interval & increase risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin & alcohol can impair cardiac tolerance towards β2-sympathomimetics. Concomitant use w/ MAOIs & similar agents eg, furazolidone, procarbazine may precipitate hypertensive reactions. Elevated risk of arrhythmias w/ concomitant anaesth w/ halogenated hydrocarbons. Additive effects w/ β-adrenergic drugs. Hypokalaemia may increase disposition towards arrhythmias in patients treated w/ digitalis glycosides.
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 80/4.5 mcg turbuhaler
Packing/Price
60 dose x 1's (Rp267,017/kontainer)
Form
Symbicort 160/4.5 mcg turbuhaler
Packing/Price
120 dose x 1's (Rp624,538/kontainer);60 dose x 1's (Rp391,374/kontainer)
/indonesia/image/info/symbicort 160-4-5 mcg turbuhaler/160-4-5 mcg x 120 doses?id=02a6ebd0-0eb6-43bc-a97d-a4e900a7fe50
/indonesia/image/info/symbicort 160-4-5 mcg turbuhaler/160-4-5 mcg x 60 doses?id=d790c1c7-2c40-4248-aad3-a4e900a76862
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