Medically reviewed by Drugs.com. Last updated on Jun 2, 2020.
Applies to the following strengths: 50 mg; 100 mg; 250 mg daily-dose; 350 mg daily-dose; 150 mg; 200 mg; 12.5 mg-25 mg; 50 mg-100 mg; 150 mg-200 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Seizures
Initial dose: 12.5 mg orally once a day for weeks 1 and 2
Titration: 25 mg orally once a day for weeks 3 and 4; 50 mg orally once a day for weeks 5 and 6; 100 mg orally once a day for weeks 7 and 8; 150 mg orally once a day for weeks 9 and 10
Maintenance Dose (starting at week 11): 200 mg orally once a day
Maximum Dose: 400 mg orally once a day
-This drug may be used as monotherapy or as adjunctive therapy.
-Dosage and titration should not be exceeded because of the potential for serious adverse reactions.
-Titration to the maximum dose should be accomplished in increments of 50 mg/day every 2 weeks; the decision to increase the dose above the maintenance dose should be based on clinical response and tolerability.
Use: For the treatment of partial-onset seizures.
Renal Dose Adjustments
Mild to severe renal impairment: Use caution; dose reduction may be considered
ESRD undergoing dialysis: Not recommended
Liver Dose Adjustments
Mild to moderate hepatic impairment (Child-Pugh, Class A or B): Maximum dose: 200 mg/day; although additional dosage reduction may be needed
Severe hepatic impairment: Use is not recommended
Geriatrics: Dose selection should be cautious, usually starting at the low end of the dosing range
Discontinuation of Therapy:
-Discontinue gradually over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal
-Hypersensitivity to this drug or any of the inactive ingredients
-Familial Short QT syndrome
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Pending Controlled Substance Scheduling
-Take orally once a day; may take any time of day with or without food
-Swallow tablets whole with liquid; do not crush or chew
-A DEA decision to schedule this drug is pending; a statement about abuse and dependence risks cannot be completed at this time.
-Monitor for changes in mood or behavior including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm.
-Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
-Patients should be instructed to avoid stopping this drug abruptly unless instructed to do so by their healthcare provider.
-Patients should be instructed to report a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction); this drug should be discontinued immediately if a serious hypersensitivity reaction is suspected.
-Patients should be instructed to report prolonged heart palpitations or loss of consciousness.
-Patients should be instructed to report any changes in mood or behavior including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm.
-Patients should understand that this drug may cause somnolence, fatigue, dizziness, and gait disturbances as well as blurred vision or diplopia; patients should be instructed to avoid hazardous tasks until they know how this drug affects them.
-Women who are pregnant or intending to become pregnant should consult with their healthcare provider; women of reproductive potential should understand that this drug may decrease the efficacy of oral contraceptives and they should use additional or alternative non-hormonal birth control.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.