- Approval Id
- 005f74dec683b012
- Drug Name
- IMIGRAN TABLET 50 MG
- Product Name
- IMIGRAN TABLET 50 MG
- Approval Number
- SIN08419P
- Approval Date
- 1995-10-26
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical form: Film coated tablets</p>
<p><em>IMIGRAN</em> should not be used prophylactically. The recommended dose of <em>IMIGRAN</em> should not be exceeded.</p>
<p>It is advisable that <em>IMIGRAN</em> be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.</p>
<p><strong>Populations</strong></p>
<ul>
<li><p><strong>Adults</strong></p>
<p>The recommended dose of oral <em>IMIGRAN</em> is a single 50 mg tablet. Some patients may require 100 mg.</p>
<p>If a patient does not respond to the first dose of <em>IMIGRAN</em>, a second dose should not be taken for the same attack. <em>IMIGRAN</em> tablets may be taken for subsequent attacks.</p>
<p>If the patient has responded to the first dose, but the symptoms recur a second dose may be given, provided that there is a minimum interval of two hours between doses and not more than 300 mg is taken in any 24-hour period.</p>
<p>The tablets should be swallowed whole with water.</p>
</li>
<li><p><strong>Children and Adolescents (under 18 years of age)</strong></p>
<p>The safety and efficacy of <em>IMIGRAN</em> tablets in this population has not been demonstrated.</p>
</li>
<li><p><strong>Elderly (over 65 years of age)</strong></p>
<p>Experience of the use of <em>IMIGRAN</em> tablets in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of <em>IMIGRAN</em> in patients aged over 65 years is not recommended.</p>
</li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>IMIGRAN</em> tablets are indicated for the acute relief of migraine attacks with or without aura, including the acute treatment of migraine attacks associated with the menstrual period in women.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<ul class="dash">
<li><p>Hypersensitivity to any component of the preparation.</p></li>
<li><p><em>IMIGRAN</em> should not be given to patients who have had myocardial infarction or have ischaemic heart disease (IHD), Prinzmetal's angina/coronary vasospasm, peripheral vascular disease or patients who have symptoms or signs consistent with IHD.</p></li>
<li><p><em>IMIGRAN</em> should not be administered to patients with a history of previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA).</p></li>
<li><p>The use of <em>IMIGRAN</em> in patients with uncontrolled hypertension is contraindicated.</p></li>
<li><p><em>IMIGRAN</em> should not be administered to patients with severe hepatic impairment.</p></li>
<li><p>The concomitant use of ergotamine or derivatives of ergotamine (including methysergide) is contraindicated (<em>see Interactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p></li>
<li><p>Concurrent administration of monoamine oxidase inhibitors (MAOIs) and <em>IMIGRAN</em> is contraindicated. <em>IMIGRAN</em> must not be used within two weeks of discontinuation of therapy with MAOIs.</p></li>
</ul>
- Atc Code
- N02CC01
- Atc Item Name
- sumatriptan
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
