ecreased are shown in five categories.
Figure 2. Proportion of Patients by Category of Seizure Response for POTIGA and Placebo Across All Three Double-blind Trials
16 HOW SUPPLIED/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.]
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
17.1 Urinary Retention
Patients should be informed that POTIGA can cause urinary retention (including urinary hesitation and dysuria). If patients experience any symptoms of urinary retention, inability to urinate, and/or pain with urination, they should be instructed to seek immediate medical assistance [see Warnings and Precautions (5.1)]. For patients who cannot reliably report symptoms of urinary retention (for example, patients with cognitive impairment), urologic consultation may be helpful.
17.2 Psychiatric Symptoms
Patients should be informed that POTIGA can cause psychiatric symptoms such as confusional state, disorientation, hallucinations, and other symptoms of psychosis. Patients and their caregivers should be instructed to notify their physicians if they experience psychotic symptoms [see Warnings and Precautions (5.2)].
17.3 Central Nervous System Effects
Patients should be informed that POTIGA may cause dizziness, somnolence, memory impairment, abnormal coordination/balance, disturbance in attention, and ophthalmological effects such as diplopia or blurred vision. Patients taking POTIGA should be advised not to drive, operate complex machinery, or engage in other hazardous activities until they have become accustomed to any such effects associated with POTIGA [see Warnings and Precautions (5.3)].
17.4 Suicidal Thinking and Behavior
Patients, their caregivers, and families should be informed that AEDs, including POTIGA, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.5)].
17.5 Pregnancy
Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy. Patients should be advised to notify their physicians if they intend to breastfeed or are breastfeeding an infant.
Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry collects information about the saf |
