Seizure disorders:
Indications for: OXTELLAR XR
Treatment of partial-onset seizures in patients ≥6yrs of age.
Adult Dosage:
Take on empty stomach. Swallow whole. ≥17yrs: Initially 600mg once daily for 1 week, then may increase by 600mg/day increments at weekly intervals; usual range 1.2g–2.4g/day. Concomitant strong CYP3A4 or UGT inducers: consider initiating at 900mg once daily. Severe renal impairment (CrCl <30mL/min): initially 300mg/day; may increase by 300–450mg/day increments at weekly intervals. ESRD on dialysis: use oxcarbazepine immediate-release. Elderly: initially 300mg or 450mg once daily; may increase by 300–450mg/day increments at weekly intervals. Conversion from oxcarbazepine immediate-release: may need higher doses.
Children Dosage:
<6yrs: not recommended. 6–<17yrs: initially 8–10mg/kg once daily; max 600mg/day in the 1st week, then may increase by 8–10mg/kg/day increments at weekly intervals; usual max 600mg/day. Target maintenance doses (attain over 2–3 weeks): 20–29kg: 900mg/day; 29.1–39kg: 1.2g/day; >39kg: 1.8g/day. Concomitant strong CYP3A4 or UGT inducers: consider initiating at 12–15mg/kg once daily; max 900mg/day in the 1st week.
OXTELLAR XR Contraindications:
Hypersensitivity to eslicarbazepine.
OXTELLAR XR Warnings/Precautions:
Risk of hyponatremia; monitor if signs/symptoms occur. Discontinue if anaphylaxis or angioedema occurs; do not rechallenge. Carbamazepine hypersensitivity. Evaluate for presence of HLA-B*1502 allele (esp. in Asians), if present avoid use; increased risk of severe dermatological reactions. Suicidal behavior and ideation; monitor. Discontinue if DRESS/multi-organ hypersensitivity occurs. Risk of seizure aggravation; discontinue if occurs. Avoid abrupt withdrawal. Severe hepatic impairment: not recommended. Monitor for seizures during pregnancy and through the postpartum period. Elderly. Pregnancy. Nursing mothers.
OXTELLAR XR Classification:
Dibenzazepine.
OXTELLAR XR Interactions:
Antagonized by strong CYP3A4 or UGT inducers (eg, phenytoin, carbamazepine, phenobarbital, rifampin); monitor and adjust dose as needed (see Adults). Monitor phenytoin levels; may need to decrease dose. May decrease effectiveness of hormonal contraceptives, other oral or implant contraceptives; use additional non-hormonal forms. Caution with other drugs known to decrease serum sodium.
Adverse Reactions:
Dizziness, somnolence, headache, balance disorder, tremor, vomiting, diplopia, asthenia, fatigue; hyponatremia, serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis); rare: pancytopenia, agranulocytosis, leukopenia (discontinue if occurs).
Drug Elimination:
Renal (primarily), fecal.
Generic Drug Availability:
NO
How Supplied:
Tabs—100
