Eslicarbazepine Acetate

DEA Class;  Rx

Common Brand Names; Aptiom

Hypersensitivity to eslicarbazepine or oxcarbazepine

• 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)

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As with all antiepileptic drugs, therapy should be withdrawn gradually because of risk of increased seizure frequency and status epilepticus, but if withdrawal is needed because of a serious adverse event, rapid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

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