Seretide舒悅泰

Seretide

salmeterol + fluticasone

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Per 50/100 mcg accuhaler Salmeterol 50 mcg, fluticasone propionate 100 mcg. Per 50/250 mcg accuhaler Salmeterol 50 mcg, fluticasone propionate 250 mcg. Per 50/500 mcg accuhaler Salmeterol 50 mcg, fluticasone propionate 500 mcg. Per 25/50 mcg inhaler Salmeterol 25 mcg, fluticasone propionate 50 mcg. Per 25/125 mcg inhaler Salmeterol 25 mcg, fluticasone propionate 125 mcg. Per 25/250 mcg inhaler Salmeterol 25 mcg, fluticasone propionate 250 mcg
Indications/Uses
Regular treatment of asthma in childn & adults, where combination therapy (bronchodilator & inhaled corticosteroid) is appropriate. Accuhaler: Maintenance treatment of COPD, including emphysema & chronic bronchitis in patients where the use of a combination product is considered appropriate. Inhaler: Symptomatic treatment of patients with severe COPD & a history of repeated exacerbations who have significant symptoms despite regular β-2 agonist bronchodilator therapy.
Dosage/Direction for Use
Asthma Adult & adolescent ≥12 yr Accuhaler 1 inhalation bd. Inhaler 2 inhalations bd. Childn 4-11 yr Accuhaler 1 inhalation of 50 mcg salmeterol/100 mcg fluticasone bd. Inhaler 2 inhalations of 25 mcg salmeterol/50 mcg fluticasone bd. COPD Adult ≥18 yr Accuhaler 1 inhalation of 50 mcg salmeterol/250 mcg (or 500 mcg) fluticasone bd. Inhaler 2 inhalations of 25 mcg salmeterol/125 mcg fluticasone bd; or 2 inhalations of 25 mcg salmeterol/250 mcg fluticasone bd.
Contraindications
Special Precautions
COPD/asthma exacerbation associated w/ infection. Systemic effects may occur w/ any inhaled corticosteroid, particularly at high doses prescribed for long periods. Sudden & progressive deterioration in asthma control. Not for relief of acute asthma symptoms. Should not be stopped abruptly. Possible development of pneumonia in patients w/ COPD. Administer w/ caution in patients w/ active or quiescent pulmonary TB; thyrotoxicosis; pre-existing CV disease; predisposition to low levels of serum K; history of DM. It is recommended that the height of childn receiving prolonged treatment w/ inhaled corticosteroid is regularly monitored. Patients in a medical emergency & elective situation likely to produce stress. Patients transferring from oral to inhalation therapy should be treated w/ special care & adrenocortical function regularly monitored. Discontinue if paradoxical bronchospasm occurs. Avoid concomitant use w/ ritonavir. Exercise caution when co-administered w/ strong CYP3A4 inhibitors (eg, ketoconazole). Should be used for the shortest duration of time required to achieve control of asthma symptoms & discontinue once achieved. Pregnancy & lactation.
Adverse Reactions
Headache. Candidiasis of mouth & throat, pneumonia (in COPD patients); hoarseness/dysphonia; muscle cramps, arthralgia. Cutaneous hypersensitivity reactions, dyspnoea; cataract; hyperglycaemia; anxiety, sleep disorders; tremor; palpitations, tachycardia, atrial fibrillation; throat irritation; contusions. Oesophageal candidiasis; anaphylactic reactions; glaucoma; behavioural changes, including hyperactivity & irritability (predominantly in childn); cardiac arrhythmias including supraventricular tachycardia & extrasystoles; angioedema (mainly facial & oropharyngeal oedema), bronchospasm; Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in childn & adolescents, decreased bone mineral density; paradoxical bronchospasm.
Drug Interactions
Avoid non-selective & selective β-blockers in asthma patients. Fluticasone: Increased plasma conc w/ ritonavir (highly potent CYP3A4 inhibitor). Potential increase in systemic exposure w/ ketoconazole. Salmeterol: Significant increase in plasma exposure & prolongation of QTc interval w/ ketoconazole.
ATC Classification
R03AK06 - salmeterol and fluticasone ; 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
Seretide 50 mcg/500 mcg accuhaler
Packing/Price
60 dose x 1's
Form
Seretide 25 mcg/50 mcg inhaler
Packing/Price
120 dose x 1's
Form
Seretide 50 mcg/100 mcg accuhaler
Packing/Price
60 dose x 1's
Form
Seretide 25 mcg/250 mcg inhaler
Packing/Price
120 dose x 1's
Form
Seretide 25 mcg/125 mcg inhaler
Packing/Price
120 dose x 1's
Form
Seretide 50 mcg/250 mcg accuhaler
Packing/Price
60 dose x 1's
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