Aptiom (Eslicarbazepine) Dosage and Treatment Protocol for Epilepsy
The recommended initial dosage of Aptiom (eslicarbazepine acetate) for adult patients with epilepsy is 400 mg administered orally once daily, with weekly increments of 400-600 mg to reach a maintenance dosage of 800-1600 mg once daily based on clinical response and tolerability. 1
Adult Dosing Protocol
- Initial dose: 400 mg orally once daily 1
- For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs increased risk of adverse reactions 1
- Titration: Increase dose in weekly increments of 400-600 mg based on clinical response and tolerability 1
- Maintenance dose: 800-1600 mg once daily 1
- For monotherapy, 800 mg daily should be considered in patients unable to tolerate 1200 mg daily 1
- For adjunctive therapy, 1600 mg daily should be considered in patients who don't achieve satisfactory response with 1200 mg daily 1
Pediatric Dosing (4-17 years)
- Dosing is weight-based and administered once daily 1
- For patients 11-21 kg: Initial dose 200 mg/day, maintenance 400-600 mg/day 1
- For patients 22-31 kg: Initial dose 300 mg/day, maintenance 500-800 mg/day 1
- For patients 32-38 kg: Initial dose 300 mg/day, maintenance 600-900 mg/day 1
- For patients >38 kg: Initial dose 400 mg/day, maintenance 800-1200 mg/day 1
Special Populations
- Renal impairment: For moderate to severe renal impairment (creatinine clearance <50 mL/min), reduce initial, titration, and maintenance doses by 50% 1
- Hepatic impairment: No dose adjustments needed for mild to moderate hepatic impairment; not recommended for severe hepatic impairment 1
Administration Considerations
- Can be taken with or without food 1
- Can be administered as whole or crushed tablets 1
- Once-daily dosing improves medication adherence compared to multiple daily dosing regimens 2, 3
Drug Interactions
- Should not be taken with oxcarbazepine 1
- When taken with carbamazepine, dose adjustments may be needed due to reduced eslicarbazepine plasma concentration 1
- Higher doses may be needed when taken with enzyme-inducing AEDs (phenobarbital, phenytoin, primidone) 1
- Eslicarbazepine is a weak enzyme inducer and inhibits CYP2C19, affecting fewer enzymes than carbamazepine 2
Efficacy and Safety Profile
- Clinical studies show that 79-83% of patients achieve ≥50% reduction in seizure frequency within 3-12 months of treatment 4
- Patients with secondary generalized tonic-clonic seizures show seizure-free rates of 69-73% 4
- Most common adverse effects include dizziness, headache, and diplopia 2
- Other reported adverse events include instability, somnolence, mild hyponatremia, and allergic reactions 4
- Most adverse events are mild to moderate in severity and occur early in treatment 3
Discontinuation Protocol
- Avoid abrupt discontinuation to minimize risk of increased seizure frequency and status epilepticus 1
- Reduce dosage gradually when discontinuing treatment 1
Clinical Pearls
- Eslicarbazepine acetate enhances slow inactivation of voltage-gated sodium channels, reducing the activity of rapidly firing neurons 2
- Once-daily dosing is a major advantage over older anti-epileptic drugs 2, 3
- Long-term treatment has shown sustained efficacy and improvements in quality of life 3
- Monitor for hyponatremia, which has been reported as an adverse effect 4