- Approval Id
- 9104da489bff8d25
- Drug Name
- SABRIL TABLET 500 MG
- Product Name
- SABRIL TABLET 500 MG
- Approval Number
- SIN07955P
- Approval Date
- 1994-12-09
- Registrant
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
- Licence Holder
- SANOFI-AVENTIS SINGAPORE 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>
SABRIL treatment may only be initiated by a specialist in epileptology, neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology.<br>
SABRIL is for oral administration once or twice daily and may be taken before or after meals. Tablets are swallowed with half a glass of water.<br>
If the control of epilepsy is not clinically significantly improved after an adequate trial, vigabatrin treatment should be discontinued. Vigabatrin should be gradually withdrawn under close medical supervision.<br>
The tablet form is not suitable for children aged less than 6 years due to the risk of choking.</p>
<p><strong>Adults:</strong><br>
Maximal efficacy is usually seen in the 2 – 3g/day range.<br>
A starting dose of 1g daily should be added to the patient's current anti-epileptic drug regimen. The daily dose should then be titrated in 0.5g increments at weekly intervals depending on clinical response and tolerability.<br>
The highest recommended dose is 3g/day.<br>
No direct correlation exists between the plasma concentration and the efficacy. The duration of the effect of the drug is dependent on the rate of GABA transaminase resynthesis rather than the concentration of the drug in the plasma (see also Sections Properties and Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Children:</strong><br>
The recommended starting dose in children is 40mg/kg/day. Maintenance recommendations in relation to bodyweight are:</p>
<table class="borderless-100">
<tbody>
<tr>
<td>Bodyweight:</td>
<td>10–15 kg</td>
<td>0.5–1 g/day</td>
</tr>
<tr>
<td colspan="1" rowspan="2"></td>
<td>15–30 kg</td>
<td>1–1.5 g/day</td>
</tr>
<tr>
<td>30–50 kg</td>
<td>1.5–3 g/day</td>
</tr>
<tr>
<td>> 50 kg</td>
<td>2–3 g/day</td>
<td></td>
</tr>
</tbody>
</table>
<p>The maximum recommended dose in each of the categories should not be exceeded.</p>
<p><strong>Elderly and Patients with renal impairment:</strong><br>
Since vigabatrin is eliminated via the kidney, caution should be exercised when administering the drug to the elderly and more particularly in patients with creatinine clearance less than 60ml/min. Adjustment of dose or frequency of administration should be considered. Such patients may respond to a lower maintenance dose. Patients should be monitored for undesirable effects such as sedation or confusion (see sections Special warnings and special precautions for use and undesirable effects – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
Treatment in combination with other anti-epileptic drugs for patients with resistant partial epilepsy with or without secondary generalization, that is where all other appropriate drug combinations have proved inadequate or have not been tolerated.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Hypersensitivity to vigabatrin or to any excipient in the medicinal product.</p>
- Atc Code
- N03AG04
- Atc Item Name
- vigabatrin
- Pharma Manufacturer Name
- SANOFI-AVENTIS SINGAPORE PTE. LTD.
