Names and pronunciation
(ox′kar-baz′uh-peen) Trileptal, Oxtellar XR
Source page 995
Loading InternPractice…
Individual generic drug information
Extracted information for OXcarbazepine only.
(ox′kar-baz′uh-peen) Trileptal, Oxtellar XR
Source page 995
Func. class.: Anticonvulsant, miscel- laneous
Source page 995
Chem. class.: CarBAMazepine analog O
Source page 995
Do not confuse: OXcarbazepine/carBAMazepine
Source page 995
ACTION: May inhibit nerve impulses by limiting influx of sodium ions across cell membrane in motor cortex
Source page 995
USES: Partial seizures
Source page 995
Extracted information for OXcarbazepine only.
CONTRAINDICATIONS: Hypersensitivity Precautions: Pregnancy, breastfeeding, children <4 yr, hypersensitivity to carBA Mazepine, renal disease, fluid restriction, hyponatremia, abrupt discontinuation, sui- cidal ideation, positive for HLA-B 1502 allele
Source page 995
SIDE EFFECTS CNS: Headache, dizziness, confusion, fatigue, feeling abnormal, ataxia, abnor- mal gait, tremors, anxiety, agitation, worsening of seizures, suicidal thoughts/ behaviors CV: Hypotension, chest pain, edema, bradycardia, syncope EENT: Blurred vision, diplopia, nystag- mus, rhinitis, sinusitis ENDO: Hypothyroidism, hot flashes GI: Nausea, constipation, diarrhea, anorexia, vomiting, abdominal pain, gastritis GU: Urinary frequency, hematuria, men- ses change INTEG: Purpura, rash, acne META: Hyponatremia RESP: Flulike symptoms SYST: Angioedema, anaphylaxis, Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosino- philia and systemic symptoms (DRESS)
Source page 996
INTERACTIONS Increase: CNS depression—alcohol Decrease: effects—felodipine, oral con- traceptive, carBAMazepine Decrease: OXcarbazepine levels—car- BAMazepine, PHENobarbital, phenytoin, valproic acid, verapamil Decrease: effect of substrates—CYP3A4 substrates (cycloSPORINE, itraconazole, rivaroxaban) Drug/Herb Increase: anticonvulsant effect—ginkgo Decrease: anticonvulsant effect—gin- seng, santonica Drug/Lab Test Decrease: sodium
Source page 996
TREATMENT OF OVERDOSE: Give 0.9% NaCl (hypotensive state), atro- pine (bradycardia); use benzodiaze- pines, barbiturates for seizures
Source page 997
Extracted information for OXcarbazepine only.
DOSAGE AND ROUTES Partial seizures, adjunctive therapy • Adult: PO IR 300 mg bid, may be in- creased by 600 mg/day in divided doses bid at weekly intervals; maintenance 1200 mg/ day; ext rel: 600 mg daily × 1 wk, increase weekly in 600 mg/day increments to 1200- 2400 mg daily • Child 4-16 yr: PO IR 8-10 mg/kg/day divided bid; dose determined by weight, increase by 5 mg/kg/day q3days, max doses weight dependent • Child 2 to <4 yr: PO IR 8-10 mg/kg divided in 2 doses, max 600 mg/day • Child 6-17 yr: PO ext rel 8-10 mg/kg daily, max 600 mg first wk, may increase weekly by 8-10 mg/kg daily, max 600 mg Conversion to monotherapy for partial seizures • Adult: PO 300 mg bid with reduction in other anticonvulsants; increase OXcar- bazepine by 600 mg/day each week over 2-4 wk; withdraw other anticonvulsants over 3-6 wk; max 2400 mg/day Initiation of monotherapy for partial seizures • Adult: PO 300 mg bid, increase by 300 mg/day q3days to 1200 mg in divided doses bid, max 2400 mg/day Renal dose • Adult: PO CCr <30 mL/min, 150 mg bid, increase slowly
Source pages 995, 996
Available forms: Film-coated tabs 150, 300, 600 mg; oral susp 300 mg/5 mL; ext rel tab 150, 300, 600 mg
Source page 996
Administer: PO route • Without regard to meals • Test for HLA-B* 1502 allele in Asian/ South Asian patient, if positive consider another treatment • Oral susp: shake well, use calibrated oral syringe provided, use or discard within 7 days of opening • Ext rel: do not crush, break, or chew • Store at room temperature
Source page 996
Extracted information for OXcarbazepine only.
Assess: • Description of seizures: frequency, duration, aura • Hyponatremia: headache, nausea, con- fusion, usually within the first 3 mo of treatment, but may occur ≤1 yr, if this product is being used with other products that decrease sodium, monitor sodium levels • Electrolyte: sodium; T4; phenytoin (when given together) • Serious reactions: angioedema, ana- phylaxis, Stevens-Johnson syndrome • CNS/mental status: mood, sensorium, affect, behavioral changes, confusion, suicidal thoughts/behaviors; if mental sta- tus changes, notify prescriber • Beers: avoid in older adults unless safer alternatives are unavailable; ataxia, impaired psychomotor function may occur • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; may cause lack of seizure control due to a metabolite of OXcarbazepine; monitor seizure con- trol; enroll in the North American Antiepi- leptic Drug (NAAED) Pregnancy Registry, 888-233-2334; do not breastfeed
Source pages 996, 997
Evaluate: • Therapeutic response: decreased sei- zure activity
Source page 997
CLINICAL CONSIDERATIONS
Source page 996
Patient and caregiver information: • To avoid driving, other activities that require alertness • Not to discontinue medication quickly after long-term use; seizures may in- crease • To inform prescriber if hypersensitive to carBAMazepine; multisystem hyper- sensitivity may occur; to report fever, other allergic symptoms • To avoid use of alcohol while taking product • To use alternative contraception if us- ing hormonal method; to report if preg- nancy is planned or suspected • To report skin rashes immediately; se- rious skin reactions can occur • To report suicidal thoughts/behavior immediately • Pregnancy/breastfeeding: if pregnant, to enroll in North American Antiepileptic Drug Pregnancy Registry, 1-888-233- 2334; not to breastfeed, excreted in breast milk
Source page 997
Extracted information for OXcarbazepine only.
PHARMACOKINETICS PO: Onset unknown; peak 4-6 hr; metab- olized by liver to active metabolite; termi- nal half-life 7-9 hr metabolite; inhibits P450 CYP2C19, induces CYP3A4/5, 95% renal extraction
Source page 996
Filter the extracted dose blocks for this individual drug.
Partial seizures, adjunctive therapy
• Adult: PO IR 300 mg bid, may be in- creased by 600 mg/day in divided doses bid at weekly intervals; maintenance 1200 mg/ day; ext rel: 600 mg daily × 1 wk, increase weekly in 600 mg/day increments to 1200- 2400 mg daily
Candidate age grouping · source pages 995, 996
Partial seizures, adjunctive therapy
• Child 4-16 yr: PO IR 8-10 mg/kg/day divided bid; dose determined by weight, increase by 5 mg/kg/day q3days, max doses weight dependent
Candidate age grouping · source pages 995, 996
Partial seizures, adjunctive therapy
• Child 2 to <4 yr: PO IR 8-10 mg/kg divided in 2 doses, max 600 mg/day
Candidate age grouping · source pages 995, 996
Partial seizures, adjunctive therapy
• Child 6-17 yr: PO ext rel 8-10 mg/kg daily, max 600 mg first wk, may increase weekly by 8-10 mg/kg daily, max 600 mg Conversion to monotherapy for partial seizures
Candidate age grouping · source pages 995, 996
Partial seizures, adjunctive therapy
• Adult: PO 300 mg bid with reduction in other anticonvulsants; increase OXcar- bazepine by 600 mg/day each week over 2-4 wk; withdraw other anticonvulsants over 3-6 wk; max 2400 mg/day Initiation of monotherapy for partial seizures
Candidate age grouping · source pages 995, 996
Partial seizures, adjunctive therapy
• Adult: PO 300 mg bid, increase by 300 mg/day q3days to 1200 mg in divided doses bid, max 2400 mg/day Renal dose
Candidate age grouping · source pages 995, 996
Partial seizures, adjunctive therapy
• Adult: PO CCr <30 mL/min, 150 mg bid, increase slowly
Candidate age grouping · source pages 995, 996