API

Salmeterol (50mcg) + Fluticasone Propionate (500mcg)

Drug classification

Combination inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) bronchodilator.

Dosage form

Dry powder for inhalation delivered via Accuhaler (DPI) device.

API strength per dosage

Salmeterol 50 mcg, Fluticasone Propionate 500 mcg per dose.

Dose

Seretide 50/500 Accuhaler is typically inhaled as one dose (one inhalation) twice daily in adults and adolescents (≥12 years) for asthma or COPD. Not recommended for children under 12 years. No dose adjustment is generally required for renal or mild-to-moderate hepatic impairment; use with caution in severe hepatic impairment. Always follow prescribing information.

Mechanism of action

Seretide Accuhaler combines salmeterol, a long-acting β2-adrenergic receptor agonist causing bronchodilation via airway smooth muscle relaxation, and fluticasone propionate, a corticosteroid that binds glucocorticoid receptors to reduce airway inflammation, edema, and mucus production, resulting in improved airflow and symptom control in asthma and chronic obstructive pulmonary disease (COPD).

Indications

Treatment of Chronic obstructive pulmonary disease (COPD)

Side effects

Headache Cough Upper respiratory tract infection Nasopharyngitis inflammation of the throat and nasal passages Sinus inflammation Stomach discomfort Fungal infection of oropharynx Tremors Palpitations Voice change

Pregnancy category

Use in pregnancy only if the expected benefit justifies the potential risk; limited human data, animal studies show potential fetal risk with high doses.

Precautions

Monitor for adrenal suppression, avoid abrupt discontinuation, caution in patients with cardiovascular disorders, monitor for paradoxical bronchospasm, use with caution in patients with severe hepatic impairment, monitor bone density in long-term use, caution in patients with diabetes or glaucoma, potential for growth suppression in children.

Contraindications

Hypersensitivity to salmeterol, fluticasone propionate, or lactose, untreated fungal, bacterial, systemic viral infections, active tuberculosis, primary treatment of status asthmaticus or acute episodes of asthma.