- Approval Id
- 3d0a54e8b810b1bf
- Drug Name
- FLIXOTIDE EVOHALER 125 MCG
- Product Name
- FLIXOTIDE EVOHALER 125 MCG
- Approval Number
- SIN11347P
- Approval Date
- 2000-07-12
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- AEROSOL, SPRAY
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical form: Pressurised metered-dose aerosol</p>
<p>Patients should be made aware of the prophylactic nature of therapy with inhaled <em>FLIXOTIDE</em> and that it should be taken regularly even when they are asymptomatic.</p>
<p><em>FLIXOTIDE</em> is for inhalation by oral inhalation only.</p>
<p>It is intended that each prescribed dose is given by a minimum of two inhalations.</p>
<p>In patients who find co-ordination of a pressurised metered dose inhaler difficult, a spacer may be used with <em>FLIXOTIDE</em> inhaler.</p>
<p><strong>ASTHMA</strong></p>
<p>The onset of therapeutic effect is four to seven days, although some benefit may be apparent as soon as 24 hours for patients who have not previously received inhaled steroids.</p>
<p>If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought.</p>
<ul>
<li><p><strong>Adults and children over 16 years of age</strong></p>
<p>100 to 1000 micrograms twice daily.</p>
<p>Patients should be given a starting dose of inhaled FLIXOTIDE which is appropriate for the severity of their disease:</p>
<table class="borderless-100">
<tbody>
<tr>
<td>Mild asthma:</td>
<td>-</td>
<td>100 to 250 micrograms twice daily.</td>
</tr>
<tr>
<td>Moderate asthma:</td>
<td>-</td>
<td>250 to 500 micrograms twice daily.</td>
</tr>
<tr>
<td>Severe asthma:</td>
<td>-</td>
<td>500 to 1000 micrograms twice daily.</td>
</tr>
</tbody>
</table>
<p>The dose may then be adjusted until control is achieved or reduced to the minimum effective dose, according to the individual response.</p>
<p>Alternatively, the starting dose of fluticasone propionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent as administered by metered-dose inhaler.</p></li>
<li><p><strong>Children 4 years of age and over</strong></p>
<p>50 to 100 micrograms twice daily.</p>
<p>Children should be given a starting dose of inhaled <em>FLIXOTIDE</em> that is appropriate for the severity of the disease.</p>
<p>The dose may then be adjusted until control is achieved, or reduced to the minimum effective dose, according to individual response.</p>
<p>It should be noted that only the 50 microgram device is suitable for the administration of this dose.</p>
<p>This presentation of <em>FLIXOTIDE</em> may not offer the required paediatric dose, in which case an alternative presentation of <em>FLIXOTIDE</em> should be considered (e.g. dry powder inhalers).</p></li>
<li><p><strong>Children aged 1 to 4 years</strong></p>
<p>Inhaled <em>FLIXOTIDE</em> is of benefit to younger children in the control of frequent and persistent asthma symptoms.</p>
<p>Clinical trials in 1 to 4 year old children have shown that the optimal control of asthma symptoms is achieved with 100 micrograms twice daily, administered via a paediatric spacer device with a face mask (such as the <em>BABYHALER</em>™). The diagnosis and treatment of asthma should be kept under regular review.</p></li>
<li><p><strong>Special patient groups</strong></p>
<p>There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.</p></li>
</ul>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>Indications</strong></p>
<p><strong>ASTHMA</strong></p>
<p><em>FLIXOTIDE</em> has a marked anti-inflammatory effect in the lungs.</p>
<p>It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy.</p>
<p>Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal after a bronchodilator. These patients will require high dose inhaled (<em>see Dosage and Administration</em>) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.</p>
<ul class="bullet">
<li><p><strong>Adults</strong></p>
<p>Prophylactic management in:</p>
<ul class="dash">
<li><p>Mild asthma (PEF values greater than 80% predicted at baseline with less than 20% variability): Patients requiring intermittent symptomatic bronchodilator asthma medication on more than an occasional basis.</p></li>
<li><p>Moderate asthma (PEF values 60–80% predicted at baseline with 20–30% variability): Patients requiring regular asthma medication and patients with unstable or worsening asthma on currently available prophylactic therapy or bronchodilator alone.</p></li>
<li><p>Severe asthma (PEF values less than 60% predicted at baseline with greater than 30% variability): Patients with severe chronic asthma. On introduction of inhaled <em>FLIXOTIDE</em>, many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly or to eliminate their requirement for oral corticosteroids.</p></li>
</ul>
</li>
<li><p><strong>Children</strong></p>
<p>Any child who requires preventative asthma medication, including patients not controlled on currently available prophylactic medication.</p>
</li>
</ul>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Hypersensitivity to any ingredient of the preparation.</p>
- Atc Code
- R03BA05
- Atc Item Name
- fluticasone
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
- Company Detail Path
- /organization/glaxosmithkline-pte-ltd
