Država: Singapur
Jezik: angleščina
Source: HSA (Health Sciences Authority)
Retigabine
GLAXOSMITHKLINE PTE LTD
N03AX21
200.0 mg
TABLET, FILM COATED
ORAL
Prescription Only
GlaxoSmithKline LLC
2014-01-24
TROBALT™ RETIGABINE QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg, 100 mg, 200 mg or 300 mg of retigabine. For a full list of excipients, see section List of Excipients. PHARMACEUTICAL FORM Film-coated tablet (tablet). 50 mg tablets: Purple, round, film-coated tablets, marked with “RTG 50” on one side. 100 mg tablets: Green, round, film-coated tablets, marked with “RTG 100” on one side. 200 mg tablets: Yellow, oblong, film-coated tablets, marked with “RTG-200” on one side. 300 mg tablets: Green, oblong, film-coated tablets, marked with “RTG-300” on one side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Adjunctive treatment of drug-resistant partial onset seizures, with or without secondary generalisation, in patients with epilepsy where other appropriate drug combinations have proved inadequate or have not been tolerated. POSOLOGY AND METHOD OF ADMINISTRATION Posology Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability. The maximum total daily starting dose is 300 mg (100 mg three times daily). Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability. An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day. The maximum total maintenance dose is 1,200 mg/day. The safety and efficacy of doses higher than 1,200 mg/day have not been established. If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember. After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed. When withdrawing Trobal Preberite celoten dokument