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OXTELLAR XR
Seizure disorders
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Drug Name:

OXTELLAR XR Rx

Generic Name and Formulations:
Oxcarbazepine 150mg, 300mg, 600mg; extended-release tablets.

Company:
Supernus Pharmaceuticals, Inc.

Therapeutic Use:

Indications for OXTELLAR XR:

Adjunctive therapy in the treatment of partial seizures in adults and in children 6–17yrs of age.

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 antiepileptics: 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.

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. Avoid abrupt withdrawal. Severe hepatic impairment: not recommended. Monitor for seizures during pregnancy and through the postpartum period. Elderly. Pregnancy (Cat.C), nursing mothers: not recommended.

Interactions:

Antagonized by phenytoin, carbamazepine, phenobarbital, valproic acid; monitor and adjust 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. May affect thyroid (T4) tests.

Pharmacological Class:

Dibenzazepine.

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).

Metabolism:

Hepatic.

Elimination:

Renal (primarily), fecal.

Generic Availability:

NO

How Supplied:

Tabs—100

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