Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated.
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 Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
There are only limited data on the safety and efficacy of retigabine in patients aged 65 years and above. A reduction in the initial and maintenance dose of Trobalt is recommended in elderly patients.
The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability. Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Retigabine and its metabolites are eliminated principally by renal excretion.
No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min; see section 5.2). The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.
For patients with end-stage renal disease receiving haemodialysis, the three daily doses should be taken as usual on the dialysis day. In addition, a single supplemental dose is recommended immediately after haemodialysis. If breakthrough seizures occur towards the end of dialysis then an additional supplemental dose may be considered at the start of subsequent dialysis sessions.
No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).
A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child-Pugh score ≥7; see section 5.2). The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2). Currently available pharmacokinetic data are described in section 5.2, but no recommendation on a posology can be made.
Trobalt is for oral use. The tablets must be taken in three divided doses each day. The tablets should be swallowed whole, and not chewed, crushed or divided.
Trobalt may be taken with or without food (see section 5.2).
There is limited experience of overdose with retigabine.
Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies. In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability. There were no reported sequelae.
In a study in volunteers, cardiac arrhythmia (cardiac arrest/asystole or ventricular tachycardia) occurred in two subjects within 3 hours of receiving a single 900 mg retigabine dose. The arrhythmias spontaneously resolved, and both volunteers recovered without sequelae.
In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring. Further management should be as recommended by the national poisons centre, where available.
Haemodialysis has been shown to reduce the plasma concentrations of retigabine and NAMR by approximately 50%.
3 years.
This medicinal product does not require any special storage conditions.
50 mg tablets:
Opaque PVC-PVDC-aluminium foil blisters. Packs containing 21or 84 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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