| Manufacturer: | Cathay Drug | |
| Distributor: | Cathay Drug | |
| Contents: | Per 50 mcg/250 mcg inhalation powd cap Salmeterol xinafoate 50 mcg, fluticasone propionate 250 mcg. Per 50 mcg/500 mcg inhalation powd cap Salmeterol xinafoate 50 mcg, fluticasone propionate 500 mcg | |
| Indications: | Maintenance & treatment of mild, moderate & severe persistent asthma in patients >5 yr & in patients w/ COPD. | |
| Dosage: | Adult & adolescent ≥12 yr 1 inhalation bid (morning & evening), approx 12 hr apart. COPD 1 inhalation bid (morning & evening), approx 12 hr apart. | |
| Contraindications: | Hypersensitivity. Previous history of paradoximal bronchospasm. | |
| Special Precautions: | Infection of nasal passages & sinuses, recent nasal surgery or injury. Do not use as single agent for asthma control. Discontinue use then shift to short acting selective β2-agonist if breakthrough asthma symptoms or acute asthma exacerbations occur. Childn (including <4 yr). Pregnancy & lactation. | |
| Side Effects / Adverse Reactions: | Fine tremor of skeletal muscle (particularly the hands), palpitations, tachycardia, nervous tensions, headaches, peripheral vasodilatation; paradoxical bronchospasm, angioedema, urticaria, hypotension & collapse.
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| Drug Interactions: | Increased risk of hypokalemia w/ other β2-agonist, corticosteroids, diuretics or xanthines. Enhanced metabolism w/ barbiturates, carbamazepine, phenytoin, primidone or rifampicin. Increased plasma conc w/ OCs or ritonavir. Excessive K loss w/ K-depleting diuretics eg thiazides or furosemide. | |
| Pregnancy Category (US FDA): |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
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| Therapeutic Category: | 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. | |
| Regulatory Classification: | Rx |
