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ezogabine (Potiga, retigabine)
FDA approved June 2011
Indications:
- adjunctive treatment of partial seizures
Dosage:
- start: 100 mg TID for 1 week
- titrate at weekly intervals; increase by <= 150 mg/day
- maintenance: 200-400 mg TID*
- taper over 3 weeks when discontinuing [7]
* 400 mg TID of limited benefit with increased incidence of adverse effects relative to 300 mg TID [7]
Monitor:
- baseline eye exam & periodic eye exams
- visual acuity testing
- dilated fundus photography
- in some cases
- fluorescein angiogram
- ocular coherence tomography
- perimetry
- electroretinogram
Adverse effects:
- sedation
- dizziness
- fatigue
- urinary retention
- memory impairment
- confusion
- psychosis
- hallucinations [6]
- may increase risk of suicidal ideation
- diplopia
- blue skin discoloration [3]
- generally occurs after 4 years of treatment
- predominantly on or around the lips or in the nail beds of the fingers or toes
- more widespread involvement of the face & legs may occur
- discoloration of the sclera & conjunctiva , on the white of the eye & inside eyelids may occur [3]
- retinal pigment disorder
- potential vision loss [4,5]
- QT prolongation
Laboratory:
- ezogabine in plasma
- ezogabine/creatinine in urine
Mechanism of action:
- facilitates opening of potassium channels
Interactions
drug adverse effects of anticonvulsants
monitor with anticonvulsants
General
anticonvulsant
Database Correlations
PUBCHEM cid=121892
References
- FDA NEWS RELEASE: June 13, 2011
FDA approves Potiga to treat seizures in adults
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258834.htm
- French JA et al. on behalf of the RESTORE 1/Study 301
Investigators.
Randomized, double-blind, placebo-controlled trial of ezogabine
(retigabine) in partial epilepsy.
Neurology 2011 Mar 30
http://www.neurology.org/content/76/18/1555
- FDA MedWatch, April 26, 2013
Potiga (Ezogabine): Drug Safety Communication - Linked To
Retinal Abnormalities And Blue Skin Discoloration.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349847.htm
- FDA Drug Safety Communication: FDA approves label changes for
anti-seizure drug Potiga (ezogabine) describing risk of
retinal abnormalities, potential vision loss, and skin
discoloration.
October 31, 2013
http://www.fda.gov/Drugs/DrugSafety/ucm372774.htm
- FDA Drug Safety Communication. June 16, 2015
Potiga (ezogabine): Drug Safety Communication - FDA Determines
2013 Labeling Adequate to Manage Risks of Retinal Abnormalities,
Potential Vision Loss, and Skin Discoloration.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm451181.htm
- Medical Knowledge Self Assessment Program (MKSAP) 17,
American College of Physicians, Philadelphia 2015
- Ezogabin (Potiga) tablets prescribing information
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Potiga/pdf/POTIGA-PI-MG.PDF