Usual Adult Dose for Seizures

Weight greater than 28 kg:

• Days 1 to 7: 150 mg orally 3 times a day
• Days 8 to 14: 300 mg orally 3 times a day
• Days 15 to 21: 450 mg orally 3 times a day
• Days 22 to ongoing: 600 mg orally 3 times a day

• Dosage should be increased based on tolerability no more frequently than every 7 days.
• Titration increments should not exceed those shown above.
• When discontinuing therapy, the dose should be decreased gradually; abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.

Usual Pediatric Dose for Seizures

2 years or older:
Weight up to 28 kg:

• Days 1 to 7: 6 mg/kg orally 3 times a day
• Days 8 to 14: 11 mg/kg orally 3 times a day
• Days 15 to 21: 16 mg/kg orally 3 times a day
• Days 22 to ongoing: 21 mg/kg orally 3 times a day

• Days 1 to 7: 150 mg orally 3 times a day
• Days 8 to 14: 300 mg orally 3 times a day
• Days 15 to 21: 450 mg orally 3 times a day
• Days 22 to ongoing: 600 mg orally 3 times a day

• Dosage should be increased based on tolerability no more frequently than every 7 days.
• Titration increments should not exceed those shown above.
• When discontinuing therapy, the dose should be decreased gradually; abrupt discontinuation should be avoided, when possible, to minimize the risk of increased seizure frequency and status epilepticus.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Liver dysfunction: Reduced dosage may be required; however, no specific guidelines have been suggested. Caution recommended.

Comments:

• Patients with liver dysfunction should be monitored for the occurrence of side effects.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Data not available

Dialysis

Data not available

Other Comments

Administration advice:

• Consult the manufacturer product information (Instructions for Use) regarding proper administration.
• Administer with food.
• Shake the bottle thoroughly for at least 1 minute and then wait for 1 minute before measuring and administering each dose.
• Measure and administer the prescribed dose using the provided oral syringe(s); do not use a household teaspoon or tablespoon (not adequate measuring devices).
• Use within 30 days of first opening the bottle, or before the "Discard After" date on the bottle, whichever is sooner, then discard any remainder.

• Store in original bottle in an upright position at 15C to 30C (59F to 86F).
• Keep the cap tightly closed.

• The manufacturer product information (Instructions for Use) should be consulted regarding proper preparation.

• Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• This drug can cause somnolence and sedation; do not operate hazardous machinery (including motor vehicles) until you are reasonably certain that this drug does not affect you adversely (e.g., impair judgement, thinking, or motor skills).
• Be alert for development/worsening of symptoms of depression, any unusual changes in mood/behavior, or emergence of suicidal thoughts, behavior, or thoughts of self-harm; report behaviors of concern immediately to health care providers.
• Do not stop using this drug without consulting health care provider.
• Use the adaptor and oral dosing syringe provided by the pharmacist.
• Notify health care provider if you become pregnant or intend to become pregnant during therapy; enroll in the North American Antiepileptic Drug Pregnancy Registry if you become pregnant.