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Potiga

"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.

Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...

Potiga

Potiga

Potiga Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Potiga (ezogabine) is a neuronal potassium channel opener indicated for use as an add-on medication to treat seizures associated with epilepsy in adults. Potiga is the first neuronal potassium channel opener developed for the treatment of epilepsy. This drug is not available as a generic. The most common adverse reactions reported by patients taking Potiga in clinical trials included dizziness, fatigue, confusion, vertigo, tremor, problems with coordination, double vision, problems paying attention, memory impairment, lack of strength, and double-vision.

Potiga is available in strengths of 50, 200, 300, and 400 mg film-coated immediate-release tablets. 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 to 400 mg 3 times daily (600 to 1,200 mg per day). Serious side effects include withdrawal seizures, QT interval changes, suicidal behavior and ideation, urinary retention, somnolence and confusion or behavioral changes. Women should inform their doctors if they are pregnant or plan to become pregnant. It is not known if Potiga will harm unborn babies. Women should inform their doctors if they are breastfeeding or plan to breastfeed. It is not known if Potiga passes into breast milk. Women should talk to their healthcare providers if they plan to breastfeed while taking Potiga. Women and their doctors should decide if it is best to take Potiga or breastfeed. Women should not do both. Safety and efficacy of Potiga in pediatric patients is yet to be established.

Our Potiga Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Potiga in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, or if you feel agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • painful or difficult urination;
  • urinating less than usual or not at all;
  • confusion, hallucinations, unusual thoughts or behavior, thoughts of suicide or hurting yourself;

Less serious side effects may include:

  • dizziness, spinning sensation;
  • weakness, loss of balance or coordination;
  • drowsiness, tired feeling;
  • memory problems, trouble concentrating;
  • blurred vision, double vision;
  • tremors;
  • problems with speech or walking;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Potiga (Ezogabine Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Potiga FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

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.

Adverse Reactions Leading to Discontinuation in All Controlled Clinical Studies

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%).

Common Adverse Reactions in All Controlled Clinical Studies

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 <1
Renal and urinary
  Dysuria < 1 1 2 4 2
  Urinary hesitation < 1 2 1 4 2
  Hematuria < 1 2 1 2 2
  Chromaturia < 1 < 1 2 3 2

Other adverse reactions reported in these 3 studies in < 2% of patients treated with POTIGA and numerically greater than placebo were increased appetite, hallucinations, myoclonus, peripheral edema, hypokinesia, dry mouth, dysphagia, hyperhydrosis, urinary retention, malaise, and increased liver enzymes.

Most of the adverse reactions appear to be dose related (especially those classified as psychiatric and nervous system symptoms), including dizziness, somnolence, confusional state, tremor, abnormal coordination, memory impairment, blurred vision, gait disturbance, aphasia, balance disorder, constipation, dysuria, and chromaturia.

POTIGA was associated with dose-related weight gain, with mean weight increasing by 0.2 kg, 1.2 kg, 1.6 kg, and 2.7 kg in the placebo, 600 mg per day, 900 mg per day, and 1,200 mg per day groups, respectively.

Additional Adverse Reactions Observed During All Phase 2 and 3 Clinical Trials

Following is a list of adverse reactions reported by patients treated with POTIGA during all clinical trials: rash, nystagmus, dyspnea, leukopenia, muscle spasms, alopecia, nephrolithiasis, syncope, neutropenia, thrombocytopenia, euphoric mood, renal colic, coma, encephalopathy.

Comparison of Gender, Age, and Race

The overall adverse reaction profile of POTIGA was similar for females and males.

There are insufficient data to support meaningful analyses of adverse reactions by age or race. Approximately 86% of the population studied was Caucasian, and 0.8% of the population was older than 65 years.

Read the entire FDA prescribing information for Potiga (Ezogabine Tablets) »

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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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