Symbicort Turbuhaler

Symbicort Turbuhaler

budesonide + formoterol

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Per 80 mcg/4.5 mcg turbuhaler Budesonide 80 mcg, formoterol 4.5 mcg. Per 160 mcg/4.5 mcg turbuhaler Budesonide 160 mcg, formoterol 4.5 mcg. Per 320 mcg/9 mcg turbuhaler Budesonide 320 mcg, formoterol 9 mcg
Indications/Uses
Treatment of asthma; asthma control including prevention & relief of symptoms & reduced risk of exacerbations; for any asthma severity where the use of inhaled corticosteroids is appropriate. 160 mcg/4.5 mcg & 320 mcg/9 mcg turbuhaler: Regular treatment of moderate to severe COPD, w/ frequent symptoms & history of exacerbations.
Dosage/Direction for Use
Individualized dosage. 80 mcg/4.5 mcg turbuhaler Symbicort maintenance & reliever therapy (SMART) Adult & adolescent (≥12 yr) 2 inhalations/day (1 inhalation in the morning & evening or as 2 inhalations in either morning or evening). Take 1 additional inhalation as needed. If symptoms persist, an additional inhalation should be taken. Max: 6 inhalations on any single occasion. Childn (≥4 yr) 1 inhalation once daily. Take 1 additional inhalation as needed. If symptoms persist, an additional inhalation should be taken. Max: 4 inhalations on any single occasion. Maintenance therapy Adult (≥18 yr) 1-2 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) 1-2 inhalations once daily or bid. May temporarily be increased to max of 4 inhalations bid during worsening of asthma. Childn (≥4 yr) 1-2 inhalations bid. Max: 4 inhalations daily. 160 mcg/4.5 mcg turbuhaler Adult (≥18 yr) COPD 2 inhalations bid. Max: 4 inhalations daily. Adult & adolescent (≥ 12 yr) Prevention or allergen or excised induced bronchoconstriction 1 inhalation as needed. Max: 6 inhalations on a single occasion. Anti-inflammatory reliever + maintenance therapy Take 1 inhalation as needed. If symptoms persist, an additional inhalation should be taken. Max: 6 inhalations on any single occasion. Patient may also take 2 inhalations/day, given as 1 inhalation in the morning & evening or as 2 inhalations in either the morning or the evening. Maintenance dose of 2 inhalations bid may be appropriate for some patients. Maintenance therapy (fixed dose) Adult (≥18 yr) 1-2 inhalations bid, up to a max of 4 inhalations bid as maintenance dose or temporarily during worsening of asthma. Adolescent (12-17 yr) 1-2 inhalations bid, may temporarily be increased to a max of 4 inhalations bid during worsening of asthma. Childn (≥4 yr) 1 inhalation bid. Max: 2 inhalations daily. 320 mcg/9 mcg turbuhaler Adult (≥18 yr) COPD 1 inhalation bid. Max: 2 inhalations daily. Maintenance therapy: Asthma 1 inhalation once daily or bid. Max of 2 inhalations bid may be required as maintenance dose or temporarily during worsening of asthma. Adolescent (12-17 yr) 1 inhalation once daily or bid. May temporarily be increased to a max of 2 inhalations bid during worsening of asthma.
Contraindications
Hypersensitivity to budesonide, formoterol, or inhaled lactose.
Special Precautions
Taper maintenance dose when discontinuing long-term treatment & do not stop abruptly. Do not use to treat severe exacerbations. Sudden & progressive deterioration in control of asthma or COPD. Risk of impaired adrenal function in patients transferring from oral steroids; those requiring high-dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose. Severe CV disorders (including heart rhythm abnormalities), DM, untreated hypokalaemia or thyrotoxicosis. Closely monitor the growth of childn & adolescent on long-term therapy. Pregnancy & lactation. 320 mcg/9 mcg turbuhaler: Childn (≥4 yr). 160 mcg/4.5 mcg & 320 mcg/9 mcg turbuhaler: Maintenance treatment may increase risk of pneumonia in patients w/ COPD.
Adverse Reactions
Palpitations; candida infections in oropharynx; pneumonia in COPD patients (for 160 mcg/4.5 mcg & 320 mcg/9 mcg turbuhaler only); headache, tremor; mild throat irritation, coughing, hoarseness.
Drug Interactions
Budesonide: Increased systemic exposure w/ CYP3A4 inhibitors eg, ketoconazole. Formoterol: Weakened or inhibited effect w/ β-adrenergic blockers (including eye drops).
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 Turbuhaler 80 mcg/4.5 mcg
Packing/Price
60 dose x 1's
Form
Symbicort Turbuhaler 160 mcg/4.5 mcg
Packing/Price
60 dose x 1's
Form
Symbicort Turbuhaler 320 mcg/9 mcg
Packing/Price
60 dose x 1's
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