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

Comments:

• 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.

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

Dose Adjustments

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

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to this drug or any of the inactive ingredients
• Familial Short QT syndrome

Dialysis

Not recommended

Other Comments

Administration advice:

• 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

• Monitor for changes in mood or behavior including emergence or worsening of depression, suicidal thoughts, or thoughts of self-harm.
• Monitor for somnolence and fatigue

• 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.

Frequently asked questions

• Does Xcopri cause weight gain or weight loss?