POTIGA™ is indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

The initial dosage should be 100 mg 3 times daily (300 mg per day). The dosage should be increased gradually at weekly intervals by no more than 50 mg 3 times daily (increase in the daily dose of no more than 150 mg per day) up to a maintenance dosage of 200 mg to 400 mg 3 times daily (600 mg to 1,200 mg per day), based on individual patient response and tolerability. This information is summarized in Table 1 under General Dosing. In the controlled clinical trials, 400 mg 3 times daily showed limited evidence of additional improvement in seizure reduction, but an increase in adverse events and discontinuations, compared to the 300 mg 3 times daily dosage. The safety and efficacy of doses greater than 400 mg 3 times daily (1,200 mg per day) have not been examined in controlled trials.

No adjustment in dosage is required for patients with mild renal or hepatic impairment (see General Dosing, Table 1). Dosage adjustment is required in patients with moderate and greater renal or hepatic impairment (see Dosing in Specific Populations, Table 1).

POTIGA should be given orally in 3 equally divided doses daily, with or without food.

POTIGA Tablets should be swallowed whole.

If POTIGA is discontinued, the dosage should be gradually reduced over a period of at least 3 weeks, unless safety concerns require abrupt withdrawal.

Table 1: Dosing Recommendations

Dosage Forms And Strengths

50 mg, purple, round, film-coated tablets debossed with “RTG 50” on one side.
200 mg, yellow, oblong, film-coated tablets debossed with “RTG-200” on one side.
300 mg, green, oblong, film-coated tablets debossed with “RTG-300” on one side.
400 mg, purple, oblong, film-coated tablets debossed with “RTG-400” on one side.

Storage And Handling

POTIGA is supplied as film-coated immediate-release tablets for oral administration containing 50 mg, 200 mg, 300 mg, or 400 mg of ezogabine in the following packs:

50-mg Tablets: purple, round, film-coated tablets debossed with “RTG 50” on one side in bottles of 90 with desiccant (NDC 0173-0810-59).

200-mg Tablets: yellow, oblong, film-coated tablets debossed with “RTG-200” on one side in bottles of 90 with desiccant (NDC 0173-0812-59).

300-mg Tablets: green, oblong, film-coated tablets debossed with “RTG-300” on one side in bottles of 90 with desiccant (NDC 0173-0813-59).

400-mg Tablets: purple, oblong, film-coated tablets debossed with “RTG-400” on one side in bottles of 90 with desiccant (NDC 0173-0814-59).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

GlaxoSmithKline, Research Triangle Park, NC 27709. June 2011

Last reviewed on RxList: 7/12/2012
This monograph has been modified to include the generic and brand name in many instances.