Symbicort Rapihaler MDI

Symbicort Rapihaler MDI

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Per 80 mcg/4.5 mcg Rapihaler MDI Budesonide 80 mcg, formoterol fumarate dihydrate 4.5 mcg. Per 160 mcg/4.5 mcg Rapihaler MDI Budesonide 160 mcg, formoterol fumarate dihydrate 4.5 mcg
Indications/Uses
Regular treatment of asthma where use of a combination (inhaled corticosteroid & long-acting β2-agonist) is appropriate. Treatment of moderate to severe COPD w/ frequent symptoms & history of exacerbations.
Dosage/Direction for Use
Individualized dosage Maintenance therapy Adult (≥18 yr) 2 inhalations once daily or bid. Max of 4 inhalations bid may be required as maintenance dose or temporarily during worsening of asthma. Adolescent (12-17 yr) 2 inhalations once daily or bid. May temporarily be increased to max of 4 inhalations bid during worsening of asthma. 80 mcg/4.5 mcg Rapihaler Childn (6-11 yr) 2 inhalations bid. Max: 4 inhalations. 160 mcg/4.5 mcg Rapihaler Adult (≥18 yr) COPD 2 inhalations bid. Max: 4 inhalations daily.
Contraindications
Hypersensitivity to budesonide or formoterol.
Special Precautions
Taper dose when discontinuing long-term treatment. Do not use to treat severe exacerbation. Monitor growth of childn & adolescents on long-term therapy. Patients transferring from oral steroids; those requiring high-dose emergency corticosteroid therapy or prolonged treatment; severe liver diseases. Severe CV disorders (including heart rhythm abnormalities), DM, untreated hypokalemia or thyrotoxicosis. May increase risk of pneumonia. Pregnancy (especially during the 1st 3 mth & shortly before delivery) & lactation.
Adverse Reactions
Palpitations; candida infections in oropharynx; headache, tremor; mild irritation in the throat, coughing, hoarseness.
Drug Interactions
Budesonide: May increase systemic exposure w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole & ritonavir. Formoterol: Weakened or inhibited effect w/ β-adrenergic blockers (including eye drops).
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 160 mcg/4.5 mcg MDI
Packing/Price
120 actuation x 1's
Form
Symbicort Rapihaler 80 mcg/4.5 mcg MDI
Packing/Price
120 actuation x 1's
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