brands

Class

• Anticonvulsant, voltage-sensitive sodium channel antagonist

OXCARBAZEPINE commonly prescribed for

(Bold for FDA approved)

How OXCARBAZEPINE works

• Acts as a use-dependent blocker of voltagesensitive sodium channels

• Interacts with the open-channel conformation of voltage-sensitive sodium channels

• Interacts at a specific site of the alpha pore-forming subunit of voltage-sensitive sodium channels

• Inhibits release of glutamate

How long until OXCARBAZEPINE works

• For acute mania, effects should occur within a few weeks

• May take several weeks to months to optimize an effect on mood stabilization

• Should reduce seizures by 2 weeks

Notable Side Effects

• Sedation (dose-dependent), dizziness (dose-dependent), headache, ataxia (dosedependent), nystagmus, abnormal gait, confusion, nervousness, fatigue

• Nausea (dose-dependent), vomiting, abdominal pain, dyspepsia

• Diplopia (dose-dependent), vertigo, abnormal vision

• Rash

Life Threatening Side Effects

• Hyponatremia

• Rare activation of suicidal ideation and behavior (suicidality)

weight gain

not usual

sedation

not usual

What to do about OXCARBAZEPINE side effects

• Wait

• Wait

• Wait

• Switch to another agent

usual dosage range

• 1200–2400 mg/day

Dosage Forms

• Tablet 150 mg, 300 mg, 600 mg

• Extended-release tablet 150 mg, 300 mg, 600 mg

• Liquid 300 mg/5 mL

long term use

• Safe

• Monitoring of sodium may be required, especially during the first 3 months

habit forming

• No

Renal Impairment

• Oxcarbazepine is renally excreted

• Elimination half-life of active metabolite MHD is increased

• Reduce initial dose by half; may need to use slower titration

Hepatic Impairment

• No dose adjustment recommended for mild to moderate hepatic impairment

• Use with caution in patients with severe impairment

Cardiac Impairment

• No dose adjustment recommended

Elderly

• Older patients may have reduced creatinine clearance and require reduced dosing

• Elderly patients may be more susceptible to adverse effects

• Some patients may tolerate lower doses better

Children and Adolescents

• Approved as adjunctive therapy or monotherapy for partial seizures in children ages 4 and older

• Ages 4–16 (adjunctive): initial 8–10 mg/ kg per day or less than 600 mg/day in 2 doses; increase over 2 weeks to 900 mg/ day (20–29 kg), 1200 mg/day (29.1–39 kg), or 1800 mg/day (>39 kg)

• When converting from adjunctive to monotherapy, titrate concomitant drug down over 3–6 weeks while titrating oxcarbazepine up by no more than 10 mg/kg per day each week, with an initial daily oxcarbazepine dose of 8–10 mg/kg per day divided in 2 doses

• Monotherapy: initial 8–10 mg/kg per day in 2 doses (immediate-release) or 1 dose (extended-release); increase every 3 days by 5 mg/kg per day; recommended maintenance dose dependent on weight

• 0–20 kg (600–900 mg/day)

• 21–30 kg (900–1200 mg/day)

• 31–40 kg (900–1500 mg/day)

• 41–45 kg (1200–1500 mg/day)

• 46–55 kg (1200–1800 mg/day)

• 56–65 kg (1200–2100 mg/day)

• over 65 kg (1500–2100 mg/day)

• Children below age 8 may have increased clearance compared to adults

Pregnancy

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

• Oxcarbazepine is structurally similar to carbamazepine, which is thought to be teratogenic in humans

• Use during first trimester may raise risk of neural tube defects (e.g., spina bifida) or other congenital anomalies

• Use in women of childbearing potential requires weighing potential benefits to the mother against the risks to the fetus

• If drug is continued, perform tests to detect birth defects

• If drug is continued, start on folate 1 mg/ day to reduce risk of neural tube defects

• Taper drug if discontinuing

• For bipolar patients, oxcarbazepine should generally be discontinued before anticipated pregnancies

• Seizures, even mild seizures, may cause harm to the embryo/fetus

• Recurrent bipolar illness during pregnancy can be quite disruptive

• For bipolar patients, given the risk of relapse in the postpartum period, some form of mood stabilizer treatment may need to be restarted immediately after delivery if patient is unmedicated during pregnancy

• Atypical antipsychotics may be preferable to lithium or anticonvulsants such as oxcarbazepine if treatment of bipolar disorder is required during pregnancy

• Bipolar symptoms may recur or worsen during pregnancy and some form of treatment may be necessary

Breast Feeding

• Some drug is found in mother’s breast milk

• Recommended either to discontinue drug or bottle feed

• If drug is continued while breast feeding, infant should be monitored for possible adverse effects

• If infant shows signs of irritability or sedation, drug may need to be discontinued

• Bipolar disorder may recur during the postpartum period, particularly if there is a history of prior postpartum episodes of either depression or psychosis

• Relapse rates may be lower in women who receive prophylactic treatment for postpartum episodes of bipolar disorder

• Atypical antipsychotics and anticonvulsants such as valproate may be safer than oxcarbazepine during the postpartum period when breast feeding