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Oxtellar Xr Generic Name & Formulations
Legal Class
Rx
General Description
Oxcarbazepine 150mg, 300mg, 600mg; ext-rel tabs.
Pharmacological Class
Dibenzazepine.
How Supplied
Tabs—100
Manufacturer
Generic Availability
NO
Oxtellar Xr Indications
Indications
Treatment of partial-onset seizures in patients ≥6yrs of age.
Oxtellar Xr Dosage and Administration
Adult
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
<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
Contraindications
Hypersensitivity to eslicarbazepine.
Oxtellar Xr Boxed Warnings
Not Applicable
Oxtellar Xr Warnings/Precautions
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 Pharmacokinetics
See Literature
Oxtellar Xr Interactions
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.
Oxtellar Xr Adverse Reactions
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).
Oxtellar Xr Clinical Trials
See Literature
Oxtellar Xr Note
Not Applicable
Oxtellar Xr Patient Counseling
See Literature
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