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POTIGA
(ezogabine) Tablets
WARNING
RETINAL ABNORMALITIES AND POTENTIAL VISION LOSS
The chemical name of ezogabine is N-[2-amino-4-(4-fluorobenzylamino)-phenyl] carbamic acid ethyl ester, and it has the following structure:
 |
The empirical formula is C16H18FN3O2, representing a molecular weight of 303.3. Ezogabine is a white to slightly colored, odorless, tasteless, crystalline powder. At room temperature, ezogabine is practically insoluble in aqueous media at pH values above 4, while the solubility is higher in polar organic solvents. At gastric pH, ezogabine is sparingly soluble in water (about 16 g/L). The pKa is approximately 3.7 (basic).
POTIGA is supplied for oral administration as 50-mg, 200-mg, 300-mg, and 400-mg film-coated immediate-release tablets. Each tablet contains the labeled amount of ezogabine and the following inactive ingredients: carmine (50-mg and 400-mg tablets), croscarmellose sodium, FD&C Blue No. 2 (50-mg, 300-mg, and 400-mg tablets), hypromellose, iron oxide yellow (200-mg and 300-mg tablets), lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.
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].
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.
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].
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) | |
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.
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
The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:
Because clinical trials are conducted under widely varying conditions and for varying durations, adverse reaction frequencies observed in the clinical trials of a drug cannot be directly compared with frequencies in the clinical trials of another drug and may not reflect the frequencies observed in practice.
POTIGA was administered as adjunctive therapy to 1,365 patients with epilepsy in all controlled and uncontrolled clinical studies during the premarketing development. A total of 801 patients were treated for at least 6 months, 585 patients were treated for 1 year or longer, and 311 patients were treated for at least 2 years.
In the 3 randomized, double-blind, placebo-controlled studies, 199 of 813 patients (25%) receiving POTIGA and 45 of 427 patients (11%) receiving placebo discontinued treatment because of adverse reactions. The most common adverse reactions leading to withdrawal in patients receiving POTIGA were dizziness (6%), confusional state (4%), fatigue (3%), and somnolence (3%).
Overall, the most frequently reported adverse reactions in patients receiving POTIGA ( ≥ 4% and occurring approximately twice the placebo rate) were dizziness (23%), somnolence (22%), fatigue (15%), confusional state (9%), vertigo (8%), tremor (8%), abnormal coordination (7%), diplopia (7%), disturbance in attention (6%), memory impairment (6%), asthenia (5%), blurred vision (5%), gait disturbance (4%), aphasia (4%), dysarthria (4%), and balance disorder (4%). In most cases the reactions were of mild or moderate intensity.
Table 4: Adverse Reaction Incidence in
Placebo-Controlled Adjunctive Trials in Adult Patients With Partial Onset
Seizures (Adverse reactions in at least 2% of patients treated with POTIGA in
any treatment group and numerically more frequent than in the placebo group.)
| Body System /Adverse Reaction | Placebo (N = 427)% |
POTIGA | |||
| 600 mg/day (N = 281)% |
900 mg/day (N = 273)% |
1,200 mg/day (N = 259)% |
All (N = 813)% |
||
| Eye | |||||
| Diplopia | 2 | 8 | 6 | 7 | 7 |
| Blurred vision | 2 | 2 | 4 | 10 | 5 |
| Gastrointestinal | |||||
| Nausea | 5 | 6 | 6 | 9 | 7 |
| Constipation | 1 | 1 | 4 | 5 | 3 |
| Dyspepsia | 2 | 3 | 2 | 3 | 2 |
| General | |||||
| Fatigue | 6 | 16 | 15 | 13 | 15 |
| Asthenia | 2 | 4 | 6 | 4 | 5 |
| Infections and infestations | |||||
| Influenza | 2 | 4 | 1 | 5 | 3 |
| Investigations | |||||
| Weight increased | 1 | 2 | 3 | 3 | 3 |
| Nervous system | |||||
| Dizziness | 9 | 15 | 23 | 32 | 23 |
| Somnolence | 12 | 15 | 25 | 27 | 22 |
| Memory impairment | 3 | 3 | 6 | 9 | 6 |
| Tremor | 3 | 3 | 10 | 12 | 8 |
| Vertigo | 2 | 8 | 8 | 9 | 8 |
| Abnormal coordination | 3 | 5 | 5 | 12 | 7 |
| Disturbance in attention | < 1 | 6 | 6 | 7 | 6 |
| Gait disturbance | 1 | 2 | 5 | 6 | 4 |
| Aphasia | < 1 | 1 | 3 | 7 | 4 |
| Dysarthria | < 1 | 4 | 2 | 8 | 4 |
| Balance disorder | < 1 | 3 | 3 | 5 | 4 |
| Paresthesia | 2 | 3 | 2 | 5 | 3 |
| Amnesia | < 1 | < 1 | 3 | 3 | 2 |
| Dysphasia | < 1 | 1 | 1 | 3 | 2 |
| Psychiatric | |||||
| Confusional state | 3 | 4 | 8 | 16 | 9 |
| Anxiety | 2 | 3 | 2 | 5 | 3 |
| Disorientation | < 1 | < 1 | < 1 | 5 | 2 |
| Psychotic disorder | 0 | 0 | < 1 | 2 | |
