- Approval Id
- 86f97b006f898a28
- Drug Name
- SERETIDE 50/500 ACCUHALER 50 MCG/500 MCG
- Product Name
- SERETIDE 50/500 ACCUHALER 50 MCG/500 MCG
- Approval Number
- SIN11032P
- Approval Date
- 1999-07-19
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- POWDER, METERED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Seretide Accuhaler is for oral inhalation only.</p>
<p>Patients should be made aware that Seretide Accuhaler must be used regularly for optimum benefit, even when asymptomatic.</p>
<p>Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal and is only changed on medical advice.</p>
<p><strong>Asthma</strong></p>
<p>The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.</p>
<p>Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease.</p>
<p>If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Seretide at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control.</p>
<p>Recommended Doses:</p>
<p>Adults and adolescents 12 years and older:</p>
<p>One inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) twice daily.</p>
<p>or</p>
<p>One inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) twice daily.</p>
<p>or</p>
<p>One inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) twice daily.</p>
<p>Children 4 years and older:</p>
<p>One inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) twice daily.</p>
<p>There are no data available for use of Seretide in children aged under 4 years.</p>
<p><strong>Chronic Obstructive Pulmonary Disease (COPD)</strong></p>
<p>For adult patients, the recommended dose is one inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) twice daily.</p>
<p><strong>Special patient groups</strong></p>
<p>There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>Indications</strong></p>
<p>Pharmaceutical form: Inhalation powder.</p>
<p>Seretide is indicated in the regular treatment of asthma where use of a combination (bronchodilator and inhaled corticosteroid) has been found to be appropriate.</p>
<p>Seretide is indicated for the symptomatic treatment of patients with severe COPD (FEV<sub>1</sub> <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Seretide is contraindicated in patients with a history of hypersensitivity to any of the ingredients.</p>
<p>Seretide Accuhaler is contraindicated in patients with severe milk protein allergy.</p>
- Atc Code
- R03AK06
- Atc Item Name
- salmeterol and fluticasone
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
