- Approval Id
- 51f45384e3775247
- Drug Name
- IMIGRAN INJECTION 6 mg/0.5 ml
- Product Name
- IMIGRAN INJECTION 6 mg/0.5 ml
- Approval Number
- SIN06744P
- Approval Date
- 1991-12-26
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical form: Solution for injection.</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 or associated symptoms such as nausea, vomiting or photophobia. It is equally effective at whatever stage of the attack it is administered.</p>
<p>The efficacy of <em>IMIGRAN</em> is independent of the duration of the attack when starting treatment.<br>
Administration during a migraine aura prior to other symptoms occurring may not prevent the development of a headache.</p>
<p><em>IMIGRAN</em> injection should be injected subcutaneously using an auto-injector.</p>
<p>Patients should be advised to observe strictly the instruction leaflet for the <em>IMIGRAN</em> auto-injector, especially regarding the safe disposal of syringes and needles.</p>
<p><strong>Populations</strong></p>
<ul>
<li><p><strong>Adults</strong></p>
<p><strong>Migraine</strong></p>
<p>The recommended dose of <em>IMIGRAN</em> injection is a single 6 mg subcutaneous injection.</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> injection 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 in the next 24 hours, provided that there is a minimum interval of 1 hour between the two doses.</p>
<p>The maximum dose in 24 hours is two 6 mg injections (12 mg).</p>
<p><strong>Cluster headache</strong></p>
<p>The recommended dose of <em>IMIGRAN</em> injection is a single 6 mg subcutaneous injection for each cluster attack. The maximum dose in 24 hours is two 6 mg injections (12 mg) with a minimum interval of 1 hour between the two doses.</p></li>
<li><p><strong>Children and Adolescents (under 18 years of age)</strong></p>
<p><em>IMIGRAN</em> injection has not been studied in adolescents or children.</p></li>
<li><p><strong>Elderly (over 65 years of age)</strong></p>
<p>Experience of the use of <em>IMIGRAN</em> 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
- SUBCUTANEOUS
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>IMIGRAN</em> injection is 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>
<p><em>IMIGRAN</em> injection is also indicated for the acute treatment of cluster headache.</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
