- Approval Id
- e5ec5af6e7f4c54e
- Drug Name
- SUMASON TABLETS 50MG
- Product Name
- SUMASON TABLETS 50MG
- Approval Number
- SIN17179P
- Approval Date
- 2025-02-12
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Posology and method of administration</strong><br>
Sumatriptan should not be used prophylactically. The recommended dose of Sumatriptan should not be exceeded.<br>
It is advisable that sumatriptan 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><em>Populations</em><br>
<em>Adults</em><br>
The recommended dose of oral sumatriptan 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 sumatriptan, a second dose should not be taken for the same attack. Sumatriptan 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>
<p><em>Children and Adolescents (under 18 years of age)</em><br>
The safety and efficacy of sumatriptan tablets in this population has not been demonstrated.</p>
<p><em>Elderly (over 65 years of age)</em><br>
Experience of the use of sumatriptan 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 sumatriptan in patients aged over 65 years is not recommended.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indication</strong><br>
Sumatriptan 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>Contraindication</strong></p>
<ul>
<li>Hypersensitivity to any component of the preparation.</li>
<li>Sumatriptan 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.</li>
<li>Sumatriptan should not be administered to patients with a history of previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA).</li>
<li>The use of sumatriptan in patients with uncontrolled hypertension is contraindicated.</li>
<li>Sumatriptan should not be administered to patients with severe hepatic impairment.</li>
<li>The concomitant use of ergotamine or derivatives of ergotamine (including methysergide) is contraindicated (see Interactions – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated. Sumatriptan must not be used within two weeks of discontinuation of therapy with MAOIs.</li>
</ul>
- Atc Code
- N02CC01
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
