- Approval Id
- 5156eb5b990cef61
- Drug Name
- AVAMYS NASAL SPRAY 27.5 MCG/SPRAY
- Product Name
- AVAMYS NASAL SPRAY 27.5 MCG/SPRAY
- Approval Number
- SIN13666P
- Approval Date
- 2009-06-23
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SPRAY, SUSPENSION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p><em>AVAMYS</em> Nasal Spray is for administration by the intranasal route only. For full therapeutic benefit regular scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. It may take several days of treatment to achieve maximum benefit. An absence of an immediate effect should be explained to the patient <em>(see Clinical Studies</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
<p><strong>Populations</strong></p>
<p>For the treatment of seasonal allergic rhinitis and perennial allergic rhinitis:</p>
<p><strong>Adults and Adolescents (12 years and older)</strong></p>
<p>The recommended starting dosage is 2 sprays (27.5 micrograms per spray) in each nostril once daily (total daily dose, 110 micrograms).</p>
<p>Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may be effective for maintenance.</p>
<p><strong>Children (2 to 11 years)</strong></p>
<p>The recommended starting dosage is 1 spray (27.5 micrograms per spray) in each nostril once daily (total daily dose, 55 micrograms).</p>
<p>Patients not adequately responding to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may use 2 sprays in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) is recommended.</p>
<p><strong>Children (under 2 years of age)</strong></p>
<p>There are no data to recommend use of intranasal fluticasone furoate for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age.</p>
<p><strong>Elderly</strong></p>
<p>No dosage adjustment required <em>(see Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
<p><strong>Renal impairment</strong></p>
<p>No dosage adjustment required <em>(see Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
<p><strong>Hepatic impairment</strong></p>
<p>No dosage adjustment is required in patients with hepatic impairment <em>(see Warnings and Precautions, and Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
- Route Of Administration
- NASAL
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>AVAMYS</em> Nasal Spray is indicated for the treatment of the symptoms of allergic rhinitis in patients 2 years of age and older.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><em>AVAMYS</em> Nasal Spray is contraindicated in patients with hypersensitivity to any of the ingredients.</p>
- Atc Code
- R01AD12
- Atc Item Name
- fluticasone furoate
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
