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 (50/250 mcg & 50/500 mcg) Maintenance treatment of COPD, including emphysema & chronic bronchitis in patients where use of combination product is considered appropriate. Inhaler (25/125 mcg & 25/250 mcg) Symptomatic treatment of patients w/ severe COPD (FEV1 <50% predicted normal) & history of repeated exacerbations who have significant symptoms despite regular β2-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 propionate bd. Inhaler 2 inhalations of 25 mcg salmeterol/50 mcg fluticasone propionate bd. COPD Adult ≥18 yr Accuhaler 1 inhalation of 50 mcg salmeterol/250 mcg (or 500 mcg) fluticasone propionate bd. Inhaler 2 inhalations of 25 mcg salmeterol/125 mcg (or 250 mcg) fluticasone propionate bd.
Contraindications
Hypersensitivity. Accuhaler Patients w/ severe milk protein allergy.
Special Precautions
Use for the shortest duration required to achieve control of asthma symptoms. Only use long-term in patients whose asthma cannot be adequately controlled on asthma controller medications. Not for relief of acute asthma symptoms. Do not stop treatment abruptly. Consider increasing corticosteroid therapy in case of sudden & progressive deterioration in asthma control. Consider additional corticosteroid therapies & administration of antibiotics if asthma/COPD exacerbation is associated w/ infection. Possible development of pneumonia in patients w/ COPD. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in childn & adolescents, decrease in bone mineral density, cataract, glaucoma & central serous chorioretinopathy. Possibility of impaired adrenal response in emergency & elective situations likely to produce stress. Regularly monitor adrenocortical function in patients transferring from oral steroid therapy to inhaled therapy. Consider very rare reports of increases in blood glucose levels when prescribing to patients w/ history of DM. Immediately discontinue treatment in case of paradoxical bronchospasm. Avoid concomitant use of fluticasone propionate & ritonavir. Caution when co-administered w/ strong CYP3A4 inhibitors (eg, ketoconazole). Caution in patients w/ active or quiescent pulmonary TB; thyrotoxicosis; pre-existing CV disease; predisposition to low levels of serum K. Consider administration during pregnancy & lactation only if expected benefit to mother is greater than any possible risk to foetus/child. No data available for use in childn <4 yr. Regularly monitor height of childn receiving prolonged treatment w/ inhaled corticosteroids. Accuhaler Contains lactose. Closely monitor patients w/ hepatic disease. Inhaler Not indicated for initiation of bronchodilator therapy in COPD.
Adverse Reactions
Headache. Candidiasis of mouth & throat, pneumonia (in COPD patients); palpitations; hoarseness/dysphonia, throat irritation; muscle cramps, arthralgia.
Drug Interactions
Avoid concomitant use w/ non-selective & selective β-blockers. Salmeterol: Significant increase in plasma exposure & QTc interval prolongation w/ ketoconazole. Fluticasone propionate: Increased plasma conc w/ ritonavir (highly potent CYP3A4 inhibitor). Potential increase in systemic exposure w/ ketoconazole (potent CYP3A4 inhibitor).
MIMS Class
Antiasthmatic & COPD Preparations
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/100 mcg accuhaler
Packing/Price
60 dose x 1's
Form
Seretide 50 mcg/250 mcg accuhaler
Packing/Price
60 dose x 1's
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 25 mcg/125 mcg inhaler
Packing/Price
120 dose x 1's
Form
Seretide 25 mcg/250 mcg inhaler
Packing/Price
120 dose x 1's
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