Home' Australian Pharmacist : Australian Pharmacist Oct 2013 Contents PLEASE REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING.
The product information can be accessed at www.gsk.com.au
Seretide (fluticasone propionate/salmeterol xinafoate) Accuhaler and MDI. Minimum Product Information. Indications: Regular treatment of asthma where the use of a
combination product is appropriate, including: patients on effective maintenance doses of long-acting β2-agonists and inhaled corticosteroids, patients who are symptomatic on current
inhaled corticosteroid therapy, initiation of maintenance therapy in patients with moderate persistent asthma not adequately controlled on 'as needed' reliever medication, and who have
moderate/severe airway limitation and daily symptoms requiring reliever medication every day. For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal)
and a history of repeated exacerbations who have significant symptoms despite regular β2-agonist bronchodilator therapy. Seretide is not indicated for the initiation of bronchodilator
therapy in COPD. Contraindications: Hypersensitivity. Precautions: Short-acting β2-agonists must be used for acute attacks. Seretide treatment should not be stopped abruptly due to
risk of exacerbation. As with all sympathomimetic drugs, especially at higher than therapeutic doses, Seretide should be used with caution in patients with pre-existing cardiovascular
disease and in patients predisposed to low levels of serum potassium. Other precautions: TB, thyrotoxicosis, pregnancy (category B3), lactation, impaired adrenal function from previous
systemic steroids, diabetes mellitus, unmasking of underlying eosinophilic conditions, unstable/deteriorating asthma. Interactions: Beta-blockers, ritonavir, ketoconazole, erythromycin.
Adverse Reactions: Arthralgia, tremor, tachycardia, palpitations, cardiac arrhythmias, headache, muscle cramps, oral candidiasis, hoarseness/dysphonia, paradoxical bronchospasm,
hypersensitivity reactions, pneumonia in patients with COPD, contusions. Rare: adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract,
glaucoma, Cushing's syndrome, Cushingoid features. Very rare: hyperglycaemia, anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in
children). Dosage: Seretide must be used regularly for optimum benefit, even when asymptomatic. Metered dose inhaler: Asthma: Adults & children >12 years: 2 inhalations BD (Seretide
MDI 50/25, 125/25 or 250/25); children ≥4 years: 2 inhalations BD (Seretide MDI 50/25). COPD: Adults: 2 inhalations BD (Seretide MDI 250/25) OR 2 inhalations BD (Seretide 125/25) in
patients at greater risk of inhaled corticosteroid adverse effects. Accuhaler: Asthma: Adults & children >12 years: 1 inhalation BD (Seretide Accuhaler 100/50, 250/50 or 500/50); Children
≥4 years: 1 inhalation BD (Seretide 100/50). COPD: Adults: 1 inhalation BD (Seretide 500/50) OR 1 inhalation BD (Seretide 250/50) in patients at greater risk of inhaled corticosteroid adverse
effects. The recommended dose for initiation of maintenance therapy in moderate persistent asthma is 100/50 micrograms fluticasone propionate/salmeterol twice daily. PI Date of TGA
Approval: 4/9/2009.For full Product Information, please contact GlaxoSmithKline Australia Pty Ltd, Melbourne, VIC. ABN 47 100 162 481. For information about GSK products or to report
an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. Seretide® is a registered trademark of the GlaxoSmithKline Group of Companies.
AUS/SFC/0037d/13 Date of approval 18/7/2013 GW0113
PBS Information -- Restricted Benefit: Asthma
Patients who previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of
inhaled corticosteroids and who have been stabilised on concomitant inhaled salmeterol xinafoate and fluticasone propionate.
PBS Information -- Restricted Benefit: COPD COPD Symptomatic treatment of chronic obstructive pulmonary disease (COPD),
where the FEV1 is less than 50% predicted normal and there is a history of repeated exacerbations with significant symptoms
despite regular ß2-agonist bronchodilator therapy. Note: Seretide is not indicated for the initiation of bronchodilator therapy in COPD.
References: 1. IMS API/AHI Audit -- Unit MAT April 2013. 2. Seretide Product Information (15 May 2013). 3. Data on File (AUS/RESP/0035/13).
*Data includes all Seretide sales in asthma and COPD.1 Seretide is indicated for the treatment
of asthma in appropriate patients from 4 years and above.2 Data includes a 10% sample
set of patients 12 years and above.3
The lung imagery depicted is an artistic representation only and does not attempt to illustrate Seretide's lung deposition or pathophysiology of an asthma/COPD patient.
ICS = inhaled corticosteroid LABA = long acting beta2 agonist
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