)
•Optimize effective dosage between 200 mg 3 times daily (600 mg per day) to 400 mg 3 times daily (1,200 mg per day). (2)
•In controlled clinical trials, 400 mg 3 times daily (1,200 mg per day) showed limited improvement compared to 300 mg 3 times daily (900 mg per day) with an increase in adverse reactions and discontinuations. (2)
•When discontinuing POTIGA, reduce the dosage gradually over a period of at least 3 weeks. (2, 5.6)
•Dosing adjustments are required for geriatric patients and patients with moderate to severe renal or hepatic impairment (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 200 mg, 300 mg, and 400 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•Urinary retention: Patients should be carefully monitored for urologic symptoms. (5.1)
•Neuropsychiatric symptoms: Monitor for confusional state, psychotic symptoms, and hallucinations. (5.2)
•Dizziness and somnolence: Monitor for dizziness and somnolence. (5.3)
•QT prolongation: QT interval should be monitored in patients taking concomitant medications known to increase the QT interval or with certain heart conditions. (5.4)
•Suicidal behavior and ideation: Monitor for suicidal thoughts or behaviors. (5.5)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥4% and approximately twice placebo) are dizziness, somnolence, fatigue, confusional state, vertigo, tremor, abnormal coordination, diplopia, disturbance in attention, memory impairment, asthenia, blurred vision, gait disturbance, aphasia, dysarthria, and balance disorder. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•Ezogabine plasma levels may be reduced by concomitant administration of phenytoin or carbamazepine. An increase in dosage of POTIGA should be considered when adding phenytoin or carbamazepine. (7.1)
•N-acetyl metabolite of ezogabine may inhibit renal clearance of digoxin, a P-glycoprotein substrate. Monitor digoxin levels. (7.2)
USE IN SPECIFIC POPULATIONS
•Pregnancy: Based on animal data, may cause fetal harm. Pregnancy registry available. (8.1)
•Pediatric use: Safety and effectiveness in patients under 18 years of age have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 04/2012
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Back to Highlights and Tabs FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Urinary Retention
5.2 Neuro-Psychiatric Symptoms
5.3 Dizziness and Somnolence
5.4 QT Interval Effect
5.5 Suicidal Behavior and Ideation
5.6 Withdrawal Seizures
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Antiepileptic Drugs
7.2 Digoxin
7.3 Alcohol
7.4 Laboratory Tests
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Patients With Renal Impairment
8.7 Patients With Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Depend |
