Renal Dose Adjustment (Based on CrCl)
- Moderate to severe renal impairment < 50mL/min: 200 mg once daily. Maintenance dose: 400 mg PO Daily after two weeks or 600 mg PO Daily
Hepatic Dose Adjustment
- Mild to moderate impairment: No dose adjustments
- Severe impairment: Dose adjustment not defined
See Supplemental Patient Information
- Increased risk of suicidal thoughts or behavior is associated in patients taking this drug. Monitor treated patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Such effects may be observed as early as 1wk after initiation of therapy and persist for the duration of treatment. Balance the risk of suicidal thoughts or behavior with the risk of untreated illness before considering prescribing therapy with this drug. On emergence of suicidal thoughts and behavior during therapy consider whether the emergence of such symptoms in any given patient is related to the illness being treated
- Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in patients undergoing therapy with this drug. Such serious skin reactions may be life threatening, and some patients may require hospitalization
- Multi-organ hypersensitivity reactions may occur; such reactions may be life threatening requiring hospitalization. Hematologic and lymphatic, hepatobiliary, renal , muscles and joints , nervous system, respiratory, hepatorenal syndrome, pruritus, and angioedema system may be affected. Discontinue therapy and initiate an alternative treatment on development of such reactions
- Rare occasions of anaphylaxis and angioedema have been occurred with therapy. Angioedema associated with laryngeal edema may be fatal. On development of any of these reactions after treatment with this drug discontinue therapy and initiate an alternative therapy
- Clinically significant hyponatremia (sodium <125 mmol/L) may occur during therapy with this drug. Measure serum sodium levels in patients undergoing maintenance therapy with this drug; it is particularly essential if the patient is having other medications known to decrease serum sodium levels or if symptoms possibly indicates presence of hyponatremia
- Neurological and cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, somnolence or fatigue, and coordination abnormalities, including ataxia and gait disturbances have occurred in patients. It may be essential to discontinue therapy on occurrence of such events
- Withdraw therapy gradually because of the risk of increased seizure frequency and status epilepticus
- Hepatic effects, ranging from mild to moderate elevations in transaminases have been reported with eslicarbazepine use. Discontinue the therapy in patients with jaundice or other evidence of significant liver injury
- Therapy is associated with decreases in serum T3 and T4. Evaluate abnormal thyroid function tests
Cautions: Use cautiously in
- Renal impairment
- Depression
- History of depression
- Suicidal tendencies
- Patients with hyponatremia
Supplemental Patient Information
- Inform patients, their caregivers, and families that this drug increases the risk of suicidal thoughts and behavior in patients. Advise them of the necessity to remain alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct them to immediately report behaviors of concern to healthcare providers
Pregnancy Category:C
Breastfeeding: According to manufacturer's data a decision should be made for discontinuing nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother.
