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Potiga

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Potiga

Potiga

INDICATIONS

POTIGA® is indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments and for whom the benefits outweigh the risk of retinal abnormalities and potential decline in visual acuity [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Dosing Information

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 Dosing in Specific Populations. 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.

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.

Dosing Considerations to Mitigate the Risk of Visual Adverse Reactions

Because POTIGA may cause retinal abnormalities with long-term use, patients who fail to show substantial clinical benefit after adequate titration should be discontinued from POTIGA. Testing of visual function should be done at baseline and every 6 months during therapy with POTIGA. Patients who cannot be monitored should usually not be treated with POTIGA. If retinal pigmentary abnormalities or vision changes are detected, POTIGA should be discontinued unless no other suitable treatment options are available and the benefits of treatment outweigh the potential risk of vision loss [see WARNINGS AND PRECAUTIONS].

Dosing in Specific Populations

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

Table 1: Dosing in Specific Populations

Specific Population Initial Dose Titration Maximum Dose
General Dosing
General population (including patients with mild renal or hepatic impairment) 100 mg 3 times daily (300 mg per day) Increase by no more than 50 mg 3 times daily, at weekly intervals 400 mg 3 times daily (1,200 mg per day)
Dosing in Specific Populations
Geriatrics (patients > 65 years) 50 mg 3 times daily (150 mg per day) Increase by no more than 50 mg 3 times daily, at weekly intervals 250 mg 3 times daily (750 mg per day)
Renal impairment (patients with CrCL < 50 mL per min or end-stage renal disease on dialysis) 50 mg 3 times daily (150 mg per day) 200 mg 3 times daily (600 mg per day)
Hepatic impairment (patients with Child-Pugh 7-9) 50 mg 3 times daily (150 mg per day) 250 mg 3 times daily (750 mg per day)
Hepatic impairment (patients with Child-Pugh > 9) 50 mg 3 times daily (150 mg per day) 200 mg 3 times daily (600 mg per day)

HOW SUPPLIED

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 tablets 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 tablets 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 tablets 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 tablets 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. September 2013

Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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