Classes
DEA Class; Rx
Common Brand Names; Aptiom
- Anticonvulsants, Other
Description
Oral anticonvulsant
Indicated as monotherapy or adjunctive treatment of partial seizures
May be better tolerated than oxcarbazepine
Indications
Indicated for partial-onset seizures as monotherapy or adjunctive therapy
Contraindications
Hypersensitivity to eslicarbazepine or oxcarbazepine
Adverse Effects
- Nausea (48%)
- Headache (31%)
- Asthenia (27%)
- Vomiting (27%)
- Somnolence (27%)
- Tremor (25%)
- Dizziness (25%)
- Abdominal pain (23%)
- Diplopia (16%)
- Diarrhea (13%)
- Anorexia (12%)
- Amblyopia/blurred vision (12%)
- Flu syndrome (12%)
- Infection (12%)
- Dyspepsia (8%)
- Ataxia (8%)
- Nystagmus (8%)
- Fever (6%)
- Emotional lability (6%)
- Thinking abnormal (6%)
- Alopecia (6%)
- Weight loss (6%)
- Constipation (5%)
- Amnesia (5%)
- Bronchitis (5%)
- Rhinitis (5%)
- Cerebral pseudoatrophy (acute or subacute cognitive decline and behavioral changes (apathy or irritability)
Warnings
Rare cases of anaphylaxis and angioedema have been reported in patients receiving therapy; anaphylaxis and angioedema associated with laryngeal edema can be fatal; if a patient develops any of these reactions after treatment and another cause cannot be established, the drug should be discontinued; patients with a prior anaphylactic-type reaction with either oxcarbazepine or this drug should not receive this therapy
As with all antiepileptic drugs, therapy should be withdrawn gradually because of risk of increased seizure frequency and status epilepticus, but if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered
Dose-dependent decreases in serum T3 and T4 (free and total) values observed in patients receiving therapy; these changes were not associated with other abnormal thyroid function tests suggesting hypothyroidism; abnormal thyroid function tests should be clinically evaluated
Rare cases of pancytopenia, agranulocytosis, and leukopenia reported during postmarketing use in patients receiving therapy; discontinuation of therapy should be considered in patients who developpancytopenia, agranulocytosis, or leukopenia
Pregnancy and Lactation
Limited available data with eslicarbazepine acetate use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
Eslicarbazepine is present in human milk; effects of eslicarbazepine acetate on the breastfed infant or on milk production are unknown
Maximum Dosage
1,600 mg/day PO.
1,600 mg/day PO.
weighing more than 38 kg: 1,200 mg/day PO.
weighing 32 to 38 kg: 900 mg/day PO.
weighing 22 to 31 kg: 800 mg/day PO.
4 to 12 years weighing more than 38 kg: 1,200 mg/day PO.
4 to 12 years weighing 32 to 38 kg: 900 mg/day PO.
4 to 12 years weighing 22 to 31 kg: 800 mg/day PO.
4 to 12 years weighing 11 to 21 kg: 600 mg/day PO.
1 to 3 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Eslicarbazepine Acetate
tablet
- 200mg
- 400mg
- 600mg
- 800mg
