Usual Adult Dose for Epilepsy

Patients receiving enzyme-inducing AED regimens:

• Initial dose: 4 mg orally once a day; modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated
• Titration: The total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or, up to 56 mg/day; the total daily dose should be given in divided doses 2 to 4 times a day
• Maximum dose: 56 mg/day (in 2 to 4 divided doses)

• The estimated plasma concentrations of this drug in non-induced patients is twice that of patients receiving enzyme-inducing AEDs. Lower doses are required and slower titration may be necessary.

• This drug should be taken with food.
• Do not use a loading dose.
• Rapid escalation and/or large dose increments should not be used.
• If a scheduled dose is missed, the patient should not make up for the missed dose by increasing the next dose; if several doses are missed, retitration may be required.
• Dosage adjustment may be needed whenever a change in the patient enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.

Usual Adult Dose for Seizures

Patients receiving enzyme-inducing AED regimens:

• Initial dose: 4 mg orally once a day; modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated
• Titration: The total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or, up to 56 mg/day; the total daily dose should be given in divided doses 2 to 4 times a day
• Maximum dose: 56 mg/day (in 2 to 4 divided doses)

• The estimated plasma concentrations of this drug in non-induced patients is twice that of patients receiving enzyme-inducing AEDs. Lower doses are required and slower titration may be necessary.

• This drug should be taken with food.
• Do not use a loading dose.
• Rapid escalation and/or large dose increments should not be used.
• If a scheduled dose is missed, the patient should not make up for the missed dose by increasing the next dose; if several doses are missed, retitration may be required.
• Dosage adjustment may be needed whenever a change in the patient enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.

Usual Pediatric Dose for Epilepsy

Less than 12 years: No dosing guidelines established.

Patients 12 years or older receiving enzyme-inducing AED regimens:

• Initial dose: 4 mg orally once a day; modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated
• Titration: The total daily dose may be increased by 4 mg at the beginning of Week 2; thereafter, the total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or up to 32 mg/day (in divided doses 2 to 4 times a day); doses above 32 mg/day have been tolerated in a small number of adolescent patients for a relatively short duration

• The estimated plasma concentrations of this drug in non-induced patients is twice that of patients receiving enzyme-inducing AEDs. Lower doses are required and slower titration may be necessary.

• This drug should be taken with food.
• Do not use a loading dose.
• Rapid escalation and/or large dose increments of should not be used.
• If a scheduled dose is missed, the patient should not make up for the missed dose by increasing the next dose; if several doses are missed, retitration may be required.
• Dosage adjustment may be needed whenever a change in the patient enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.

Usual Pediatric Dose for Seizures

Less than 12 years: No dosing guidelines established.

Patients 12 years or older receiving enzyme-inducing AED regimens:

• Initial dose: 4 mg orally once a day; modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated
• Titration: The total daily dose may be increased by 4 mg at the beginning of Week 2; thereafter, the total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or up to 32 mg/day (in divided doses 2 to 4 times a day); doses above 32 mg/day have been tolerated in a small number of adolescent patients for a relatively short duration

• The estimated plasma concentrations of this drug in non-induced patients is twice that of patients receiving enzyme-inducing AEDs. Lower doses are required and slower titration may be necessary.

• This drug should be taken with food.
• Do not use a loading dose.
• Rapid escalation and/or large dose increments of should not be used.
• If a scheduled dose is missed, the patient should not make up for the missed dose by increasing the next dose; if several doses are missed, retitration may be required.
• Dosage adjustment may be needed whenever a change in the patient enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Reduce the dose and/or prolong the dose interval.

Dose Adjustments

• Consider dosage adjustment when a change in enzyme-inducing status occurs due to the addition, discontinuation, or dose change of the enzyme-inducing agent.
• If multiple doses are missed, evaluate if retitration is clinically indicated.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken with food.
• Modification of concomitant antiepileptic drugs is not necessary, unless it is indicated clinically.

• Patients should be informed of the availability of a Medication Guide, and they should be instructed to read it prior to taking this drug.