Concise Prescribing Info
Contents
Per Seretide Diskus 100 Salmeterol 50 mcg, fluticasone propionate 100 mcg. Per Seretide Diskus 250 Salmeterol 50 mcg, fluticasone propionate 250 mcg. Per Seretide Diskus 500 Salmeterol 50 mcg, fluticasone propionate 500 mcg. Per Seretide 50 dose inhaler Salmeterol 25 mcg, fluticasone propionate 50 mcg. Per Seretide 125 dose inhaler Salmeterol 25 mcg, fluticasone propionate 125 mcg
Indications/Uses
Regular treatment of COPD including chronic bronchitis & emphysema. Patients on effective maintenance doses of long-acting β-agonists & inhaled corticosteroids, who are symptomatic on current inhaled corticosteroid therapy & on regular bronchodilator therapy who require inhaled corticosteroids. Diskus: Regular treatment of reversible obstructive airways disease (ROAD) including asthma in childn & adults where use of combination therapy (bronchodilator & inhaled corticosteroid) is appropriate. Inhaler: Regular treatment of asthma (ROAD).
Dosage/Direction for Use
ROAD Adult & adolescent ≥12 yr 2 inhalation of Seretide Inhaler 50 or 125 twice daily or 1 inhalation of Seretide Diskus 100, 250 or 500 twice daily. Childn ≥4 yr 2 inhalation of Seretide Inhaler 50 twice daily or 1 inhalation of Seretide Diskus 100 twice daily. COPD Adult 2 inhalation of Seretide Inhaler 125 twice daily or 1 inhalation of Seretide Diskus 250 or 500 twice daily.
Contraindications
Hypersensitivity. Diskus: Patients w/ severe milk-protein allergy.
Special Precautions
Not for relief of acute asthma symptoms. Consider increasing corticosteroid therapy in sudden & progressive deterioration of asthma control. Do not stop treatment abruptly. Possible development of pneumonia in patients w/ COPD. Active or quiescent pulmonary TB, thyrotoxicosis, preexisting CV disease. Patients predisposed to low serum K levels. Possible systemic effects (including Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in childn & adolescents, decrease in bone mineral density, cataract, glaucoma & central serous chorioretinopathy) may occur at high doses for prolonged periods. Monitor height of childn receiving prolonged treatment. Possibility of impaired adrenal response in patients transferring from oral steroid therapy. Consider very rare reports of increases in blood glucose levels when prescribing to patients w/ history of DM. Avoid concomitant use w/ ritonavir. Concomitant use w/ strong CYP3A4 inhibitors eg, ketoconazole. Discontinue use if paradoxical bronchospasm occurs. Pregnancy & lactation. Childn <4 yr. Diskus: Not for initial management of asthma.
Adverse Reactions
Headache. Mouth & throat candidiasis, pneumonia (in COPD patients); hoarseness/dysphonia; muscle cramps, arthralgia.
Drug Interactions
Avoid concomitant use w/ non-selective & selective β-blockers. Increased CV side effects w/ MAOIs, TCAs, l-dopa, l-thyroxine, oxytocin & antiarrhytmics. Risk of hypokalaemia w/ xanthines. Fluticasone propionate: Increased plasma conc w/ ritonavir (highly potent CYP3A4 inhibitor). Potential increase in systemic exposure w/ ketoconazole (potent CYP3A4 inhibitor). Salmeterol: Significant increase in plasma exposure & QTc interval prolongation w/ ketoconazole.
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 inhaler
Packing/Price
(w/counter) 120 actuation x 1's
Form
Seretide 125 inhaler
Packing/Price
(w/ counter) 120 actuation x 1's
Form
Seretide diskus 100
Packing/Price
60's
Form
Seretide diskus 250
Packing/Price
60's
Form
Seretide diskus 500
Packing/Price
60's
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