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Pronunciation
(ox car BAZ e peen)
Generic Available (U.S.)
Yes
Index Terms
Medication Guide
An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM246799.pdf, must be dispensed with this medication.
REMS Components
Medication Guide
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ≥4 years of age with epilepsy; adjunctive therapy in the treatment of partial seizures in children ≥2 years of age with epilepsy
Use: Unlabeled
Bipolar disorder; treatment of neuropathic pain
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in animal reproduction studies; therefore, the manufacturer classifies oxcarbazepine as pregnancy category C. Oxcarbazepine, the active metabolite MHD and the inactive metabolite DHD, crosses the placenta and can be detected in the newborn. An increased risk in the overall rate of major congenital malformations has not been observed following maternal use of oxcarbazepine. Available studies have not been large enough to determine if there is an increased risk of specific defects. In general, the risk of teratogenic effects is higher with AED polytherapy than monotherapy. Plasma concentrations of MHD gradually decrease due to physiologic changes which occur during pregnancy; patients should be monitored during pregnancy and postpartum. Oxcarbazepine may decrease plasma concentrations of hormonal contraceptives.Patients exposed to oxcarbazepine during pregnancy are encouraged to enroll themselves into the AED Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.
Lactation
Enters breast milk/not recommended
Breast-Feeding Considerations
Oxcarbazepine and the active 10-hydroxy metabolite (MHD) are found in breast milk (small amounts). According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.
Contraindications
Hypersensitivity to oxcarbazepine or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Blood dyscrasias: Agranulocytosis, leukopenia, and pancytopenia have been reported with use (rare); discontinuation and conversion to alternate therapy may be required.
• CNS effects: Use has been associated with CNS-related adverse events, most significant of these were cognitive symptoms including psychomotor slowing, difficulty with concentration, and speech or language problems, somnolence or fatigue, and coordination abnormalities, including ataxia and gait disturbances. Caution patients about performing tasks which require mental alertness (eg, operating machinery or driving).
• Dermatologic reactions: Potentially serious, sometimes fatal, dermatologic reactions (eg, Stevens-Johnson, toxic epidermal necrolysis) have been reported in adults and children; monitor for signs and symptoms of skin reactions; discontinuation and conversion to alternate therapy may be required.
• Hypersensitivity reactions: Rare cases of anaphylaxis and angioedema have been reported, even after initial dosing; permanently discontinue should symptoms occur. Use caution in patients with previous hypersensitivity to carbamazepine (cross-sensitivity occurs in 25% to 30%). Potentially serious, sometimes fatal multiorgan hypersensitivity reactions have also been reported; monitor for signs and symptoms of possible disparate manifestations associated with lymphatic, hepatic, renal, and/or hematologic organ systems; discontinuation and conversion to alternate therapy may be required.
• Hyponatremia: Clinically-significant hyponatremia (serum sodium <125 mmol/L) may develop during use; consider monitoring serum sodium, particularly during the first 3 months of therapy especially in patients at risk for hyponatremia.
• Suicidal ideation: Pooled analysis of trials involving various antiepileptics (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared to 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials ≤24 weeks). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; patients should be instructed to notify healthcare provider immediately if symptoms occur.
Disease-related concerns:
• Renal impairment: Single-dose studies show that half-life of the primary active metabolite is prolonged 3-4 fold and AUC is doubled in patients with Clcr <30 mL/minute; dose adjustment required in these patients.
Concurrent drug therapy issues:
• Oral contraceptives: May reduce the efficacy of oral contraceptives; nonhormonal contraceptive measures are recommended.
• Sedatives: Effects with other sedative drugs or ethanol may be potentiated.
Other warnings/precautions:
• Withdrawal: Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.
Adverse Reactions
As reported in adults with doses of up to 2400 mg/day (includes patients on monotherapy, adjunctive therapy, and those not previously on AEDs); incidence in children was similar.
>10%:
Central nervous system: Dizziness (22% to 49%), somnolence (20% to 36%), headache (13% to 32%), ataxia (5% to 31%), fatigue (12% to 15%), vertigo (6% to 15%)
Gastrointestinal: Vomiting (7% to 36%), nausea (15% to 29%), abdominal pain (10% to 13%)
Neuromuscular & skeletal: Abnormal gait (5% to 17%), tremor (3% to 16%)
Ocular: Diplopia (14% to 40%), nystagmus (7% to 26%), abnormal vision (4% to 14%)
1% to 10%:
Cardiovascular: Hypotension (≤2%), leg edema (1% to 2%)
Central nervous system: Nervousness (2% to 5%), amnesia (4%), abnormal thinking (≤4%), insomnia (2% to 4%), fever (3%), speech disorder (1% to 3%), abnormal feelings (≤2%), EEG abnormalities (≤2%), agitation (1% to 2%), confusion (1% to 2%)
Dermatologic: Rash (4%), acne (1% to 2%)
Endocrine & metabolic: Hyponatremia (1% to 3%)
Gastrointestinal: Diarrhea (5% to 7%), dyspepsia (5% to 6%), constipation (2% to 6%), taste perversion (5%), xerostomia (3%), gastritis (1% to 2%), weight gain (1% to 2%)
Genitourinary: Micturition (2%)
Neuromuscular & skeletal: Weakness (3% to 6%), back pain (4%), falling down (4%), abnormal coordination (1% to 4%), dysmetria (1% to 3%), sprains/strains (≤2%), muscle weakness (1% to 2%)
Ocular: Abnormal accommodation (≤2%)
Respiratory: Upper respiratory tract infection (7%), rhinitis (2% to 5%), chest infection (4%), epistaxis (4%), sinusitis (4%)
Postmarketing and/or case reports: Aggressive reaction, alopecia, amylase increased, anaphylaxis, angioedema, anguish, anxiety, aphasia, apathy, aplastic anemia, appetite increased, asthma, aura, belching, biliary pain, blood in stool, bradycardia, bruising, cardiac failure, cataract, cerebral hemorrhage, chest pain, cholelithiasis, colitis, conjunctival hemorrhage, consciousness decreased, contact dermatitis, convulsions aggravated, delirium, delusion, duodenal ulcer, dysphagia, dysphonia, dyspnea, dystonia, dysuria, eczema, emotional lability, enteritis, erythema multiforme, erythematosus rash, esophagitis, euphoria, eye edema, extrapyramidal disorder, facial rash, feeling inebriated, flatulence, folliculitis, gastric ulcer, GGT increased, gingival bleeding, gingival hyperplasia, heat rash, hematuria, hemianopia, hemiplegia, hematemesis, hemorrhoids, hiccups, hot flushes, hyper-/hypoglycemia, hyper-/hypokinesia, hyper-/hyporeflexia, hyper-/hypotonia, hypersensitivity reaction, hypertension, hypocalcemia, hypochondrium pain (right side), hypoesthesia, hypokalemia, hysteria, intermenstrual bleeding, laryngismus, leukopenia, leukorrhea, libido changes, lipase increased, liver enzymes elevated, maculopapular rash, malaise, manic reaction, migraine, menorrhagia, multiorgan hypersensitivity (eosinophilia, arthralgia, rash, fever, lymphadenopathy), muscle contractions (involuntary), mydriasis, neuralgia, oculogyric crisis, otitis externa, palpitation, pancreatitis, pancytopenia, panic disorder, paralysis, paroniria, personality disorder, photophobia, photosensitivity reaction, pleurisy, polyuria, postural hypotension, priapism, pruritus, purpura, psoriasis, psychosis, ptosis, rectal hemorrhage, renal calculus, renal pain, retching, rigors, scotoma, sialoadenitis, Stevens-Johnson syndrome, stupor, suicidal behavior/ideation, syncope, systemic lupus erythematosus, tachycardia, tetany, thrombocytopenia, tinnitus, toxic epidermal necrolysis, ulcerative stomatitis, urinary tract pain, urticaria, vitiligo, weight loss, xerophthalmia
Metabolism/Transport Effects
Induces CYP3A4 (strong)
Drug Interactions
ARIPiprazole: CYP3A4 Inducers may decrease the serum concentration of ARIPiprazole. Management: Double aripiprazole dose when initiating concomitant therapy with a CYP3A4 inducer (e.g., carbamazepine). Monitor response and adjust aripiprazole dose as clinically indicated. If CYP3A4 inducer is discontinued, reduce aripiprazole dose to 10-15 mg/day. Risk D: Consider therapy modification
Boceprevir: CYP3A4 Inducers (Strong) may decrease the serum concentration of Boceprevir. Management: Avoid strong CYP3A4 inducers with boceprevir when possible, and closely monitor response to boceprevir if such a combination cannot be avoided. Carbamazepine, phenytoin, phenobarbital, rifampin, and St. John's wort are considered contraindicated. Risk D: Consider therapy modification
Bortezomib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Bortezomib. Risk X: Avoid combination
Brentuximab Vedotin: CYP3A4 Inducers (Strong) may decrease the serum concentration of Brentuximab Vedotin. Specifically, concentrations of the active monomethyl auristatin E (MMAE) component may be decreased. Risk C: Monitor therapy
Clarithromycin: CYP3A4 Inducers (Strong) may increase serum concentrations of the active metabolite(s) of Clarithromycin. Clarithromycin may increase the serum concentration of CYP3A4 Inducers (Strong). CYP3A4 Inducers (Strong) may decrease the serum concentration of Clarithromycin. Risk D: Consider therapy modification
Contraceptives (Estrogens): OXcarbazepine may decrease the serum concentration of Contraceptives (Estrogens). Contraceptive failure is possible. Management: Use of an alternative, nonhormonal contraceptive is recommended. Risk D: Consider therapy modification
Contraceptives (Progestins): OXcarbazepine may decrease the serum concentration of Contraceptives (Progestins). Management: Contraceptive failure is possible. Use of an additional or alternative, nonhormonal method of contraception is recommended. Risk D: Consider therapy modification
Crizotinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Crizotinib. Risk X: Avoid combination
CYP3A4 Substrates: CYP3A4 Inducers (Strong) may increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Dasatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Dasatinib. Management: Avoid when possible. If such a combination cannot be avoided, consider increasing dasatinib dose and monitor clinical response and toxicity closely. Risk D: Consider therapy modification
Divalproex: May decrease the serum concentration of OXcarbazepine. Risk C: Monitor therapy
Dronedarone: CYP3A4 Inducers (Strong) may decrease the serum concentration of Dronedarone. Risk X: Avoid combination
Everolimus: CYP3A4 Inducers (Strong) may decrease the serum concentration of Everolimus. Management: Avoid concurrent use of strong CYP3A4 inducers, but if strong CYP3A4 inducers cannot be avoided, consider gradually (in 5 mg increments) increasing the everolimus dose from 10 mg/day to 20 mg/day (adult doses). Risk X: Avoid combination
Exemestane: CYP3A4 Inducers (Strong) may decrease the serum concentration of Exemestane. Management: Exemestane prescribing information recommends using an increased dose (50 mg/day) in patients receiving concurrent strong CYP3A4 inducers. Monitor patients closely for evidence of toxicity and/or inadequate clinical response. Risk D: Consider therapy modification
Fosphenytoin: May decrease the serum concentration of OXcarbazepine. OXcarbazepine may increase the serum concentration of Fosphenytoin. Risk C: Monitor therapy
Gefitinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Gefitinib. Management: In the absence of severe adverse drug reactions, consider increasing gefitinib dose to 500 mg daily in patients receiving strong CYP3A4 inducers. Carefully monitor clinical response and development of adverse reactions. Risk D: Consider therapy modification
GuanFACINE: CYP3A4 Inducers (Strong) may decrease the serum concentration of GuanFACINE. Management: Consider increasing the guanfacine dose (within the labeled dosage range) when such a combination is used. Risk D: Consider therapy modification
Imatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Imatinib. Management: Avoid concurrent use of imatinib with strong CYP3A4 inducers when possible. If such a combination must be used, increase imatinib dose by at least 50% and monitor the patient's clinical response closely. Risk D: Consider therapy modification
Ixabepilone: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ixabepilone. Management: Avoid this combination whenever possible. If this combination must be used, a gradual increase in ixabepilone dose from 40 mg/m2 to 60 mg/m2 (given as a 4-hour infusion), as tolerated, should be considered. Risk D: Consider therapy modification
Lapatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Lapatinib. Management: If therapy overlap cannot be avoided, consider titrating lapatinib gradually from 1,250 mg/day up to 4,500 mg/day (HER2 positive metastatic breast cancer) or 1,500 mg/day up to 5,500 mg/day (hormone receptor/HER2 positive breast cancer) as tolerated. Risk X: Avoid combination
Linagliptin: CYP3A4 Inducers (Strong) may decrease the serum concentration of Linagliptin. Management: Strongly consider using an alternative to any strong CYP3A4 inducer in patients who are being treated with linagliptin. If this combination is used, monitor patients closely for evidence of reduced linagliptin effectiveness. Risk D: Consider therapy modification
Lurasidone: CYP3A4 Inducers (Strong) may decrease the serum concentration of Lurasidone. Risk X: Avoid combination
Maraviroc: CYP3A4 Inducers (Strong) may decrease the serum concentration of Maraviroc. Management: Increase maraviroc adult dose to 600 mg twice daily when used with strong CYP3A4 inducers. This does not apply to patients also receiving strong CYP3A4 inhibitors. Do not use maraviroc with strong CYP3A4 inducers in patients with Clcr less than 30 mL/min. Risk D: Consider therapy modification
NIFEdipine: CYP3A4 Inducers (Strong) may decrease the serum concentration of NIFEdipine. Management: Consider alternatives to nifedipine for patients who are using strong CYP3A4 inducers. At least one specific brand of nifedipine (Adalat CC) lists this combination as contraindicated. Risk D: Consider therapy modification
Nilotinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Nilotinib. Risk X: Avoid combination
Nisoldipine: CYP3A4 Inducers (Strong) may decrease the serum concentration of Nisoldipine. Risk X: Avoid combination
Pazopanib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Pazopanib. Risk X: Avoid combination
PHENobarbital: May decrease the serum concentration of OXcarbazepine. Risk C: Monitor therapy
Phenytoin: OXcarbazepine may increase the serum concentration of Phenytoin. Phenytoin may decrease the serum concentration of OXcarbazepine. Risk C: Monitor therapy
Praziquantel: CYP3A4 Inducers (Strong) may decrease the serum concentration of Praziquantel. Management: Avoid concomitant use of praziquantel with strong CYP3A4 inducers. Discontinue rifampin 4 weeks prior to initiation of praziquantel therapy. Rifampin may be resumed the day following praziquantel completion. Risk X: Avoid combination
Ranolazine: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ranolazine. Risk X: Avoid combination
Rilpivirine: OXcarbazepine may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination
Rivaroxaban: CYP3A4 Inducers (Strong) may decrease the serum concentration of Rivaroxaban. Risk X: Avoid combination
Roflumilast: CYP3A4 Inducers (Strong) may decrease the serum concentration of Roflumilast. Management: Roflumilast U.S. prescribing information recommends against combining strong CYP3A4 inducers with roflumilast. The Canadian product monograph makes no such recommendation but notes that such agents may reduce roflumilast therapeutic effects. Risk X: Avoid combination
RomiDEPsin: CYP3A4 Inducers (Strong) may decrease the serum concentration of RomiDEPsin. Risk X: Avoid combination
Saxagliptin: CYP3A4 Inducers may decrease the serum concentration of Saxagliptin. Risk C: Monitor therapy
Selegiline: OXcarbazepine may enhance the serotonergic effect of Selegiline. Risk X: Avoid combination
SORAfenib: CYP3A4 Inducers (Strong) may decrease the serum concentration of SORAfenib. Risk X: Avoid combination
SUNItinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of SUNItinib. Management: Avoid when possible. If such a combination cannot be avoided, consider increasing sunitinib dose and monitor clinical response and toxicity closely. Risk D: Consider therapy modification
Tadalafil: CYP3A4 Inducers (Strong) may decrease the serum concentration of Tadalafil. Management: Erectile dysfunction: monitor for decreased effectiveness - no standard dose adjustments recommended. Avoid use of tadalafil for pulmonary arterial hypertension in patients receiving a strong CYP3A4 inducer. Risk D: Consider therapy modification
Thiazide Diuretics: May enhance the adverse/toxic effect of OXcarbazepine. Specifically, there may be an increased risk for hyponatremia. Risk C: Monitor therapy
Ticagrelor: CYP3A4 Inducers (Strong) may decrease serum concentrations of the active metabolite(s) of Ticagrelor. CYP3A4 Inducers (Strong) may decrease the serum concentration of Ticagrelor. Risk X: Avoid combination
Tolvaptan: CYP3A4 Inducers (Strong) may decrease the serum concentration of Tolvaptan. Management: If concurrent use is necessary, increased doses of tolvaptan (with close monitoring for toxicity and clinical response) may be needed. Risk X: Avoid combination
Toremifene: CYP3A4 Inducers (Strong) may decrease the serum concentration of Toremifene. Risk X: Avoid combination
Ulipristal: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ulipristal. Risk C: Monitor therapy
Valproic Acid: May decrease the serum concentration of OXcarbazepine. Risk C: Monitor therapy
Vandetanib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Vandetanib. Risk X: Avoid combination
Vemurafenib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Vemurafenib. Risk C: Monitor therapy
Zuclopenthixol: CYP3A4 Inducers (Strong) may decrease the serum concentration of Zuclopenthixol. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: St John's wort may decrease oxcarbazepine levels. Avoid evening primrose (seizure threshold decreased). Avoid valerian, St John's wort, kava kava, gotu kola.
Storage
Store tablets and suspension at 25°C (77°F). Use suspension within 7 weeks of first opening container.
Mechanism of Action
Pharmacological activity results from both oxcarbazepine and its monohydroxy metabolite (MHD). Precise mechanism of anticonvulsant effect has not been defined. Oxcarbazepine and MHD block voltage-sensitive sodium channels, stabilizing hyperexcited neuronal membranes, inhibiting repetitive firing, and decreasing the propagation of synaptic impulses. These actions are believed to prevent the spread of seizures. Oxcarbazepine and MHD also increase potassium conductance and modulate the activity of high-voltage activated calcium channels.
Pharmacodynamics/Kinetics
Absorption: Complete; food has no affect on rate or extent
Distribution: MHD: Vd: 49 L
Protein binding, serum: MHD: 40%
Metabolism: Hepatic to 10-monohydroxy metabolite (MHD; active); MHD is further glucuronidated or oxidized to a 10,11-dihydroxy metabolite (DHD; inactive)
Bioavailability: Decreased in children <8 years; increased in elderly >60 years
Half-life elimination: Parent drug: 2 hours; MHD: 9 hours; renal impairment (Clcr 30 mL/minute): MHD: 19 hours
Clearance of MHD is increased in younger children (~80% in children 2-4 years of age) and approaches that of adults by ~13 years of age
Time to peak, serum (median): Tablets: 4.5 hours; oral suspension: 6 hours
Excretion: Urine (95%, <1% as unchanged oxcarbazepine, 27% as unchanged MHD, 49% as MHD glucuronides); feces (<4%)
Dosage
Oral:
Children 2-3 years:
Adjunctive therapy: 8-10 mg/kg/day, not to exceed 600 mg/day, given in 2 divided daily doses. Maintenance dose should be achieved over 2 weeks, and is dependent upon patient weight.
<20 kg: Consider initiating dose at 16-20 mg/kg/day; maximum maintenance dose should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day (maximum: 600 mg/day)
Children 4-16 years:
Adjunctive therapy: 8-10 mg/kg/day, not to exceed 600 mg/day, given in 2 divided daily doses. Maintenance dose should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:
20-29 kg: 900 mg/day in 2 divided doses
29.1-39 kg: 1200 mg/day in 2 divided doses
>39 kg: 1800 mg/day in 2 divided doses
Children 4-16 years:
Conversion to monotherapy: Oxcarbazepine 8-10 mg/kg/day in twice daily divided doses, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drug; the concomitant drug should be withdrawn over 3-6 weeks. Oxcarbazepine dose may be increased by a maximum of 10 mg/kg/day at weekly intervals. See below for recommended total daily dose by weight.
Initiation of monotherapy: Oxcarbazepine should be initiated at 8-10 mg/kg/day in twice daily divided doses; doses may be titrated by 5 mg/kg/day every third day. See below for recommended total daily dose by weight.
Range of maintenance doses by weight during monotherapy:
20 kg: 600-900 mg/day
25-30 kg: 900-1200 mg/day
35-40 kg: 900-1500 mg/day
45 kg: 1200-1500 mg/day
50-55 kg: 1200-1800 mg/day
60-65 kg: 1200-2100 mg/day
70 kg: 1500-2100 mg/day
Adults:
Adjunctive therapy: Initial: 600 mg/day in 2 divided doses; dose may be increased by as much as 600 mg/day at weekly intervals; recommended daily dose: 1200 mg/day in 2 divided doses. Although daily doses >1200 mg/day were somewhat more efficacious, most patients were unable to tolerate 2400 mg/day (due to CNS effects).
Conversion to monotherapy: Oxcarbazepine 600 mg/day in 2 divided doses while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drug. The concomitant drug should be withdrawn over 3-6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2-4 weeks. Recommended daily dose: 2400 mg/day.
Initiation of monotherapy: Initial: 600 mg/day in 2 divided doses; doses may be titrated upward by 300 mg/day every third day to a final dose of 1200 mg/day given in 2 divided doses
Dosing adjustment in renal impairment: Clcr <30 mL/minute: Therapy should be initiated at one-half the usual starting dose (300 mg/day in adults) and increased slowly to achieve desired clinical response
Dosing adjustment in hepatic impairment: Adjustment not needed for mild-to-moderate impairment. No data in patients with severe impairment.
Administration: Oral
All dosing should be administered twice daily.
Suspension: Prior to using for the first time, firmly insert the plastic adapter provided with the bottle. Cover adapter with child-resistant cap when not in use. Shake bottle for at least 10 seconds, remove child-resistant cap, and insert the oral dosing syringe provided to withdraw appropriate dose. Dose may be taken directly from oral syringe or may be mixed in a small glass of water immediately prior to swallowing. Rinse syringe with warm water after use and allow to dry thoroughly. Discard any unused portion after 7 weeks of first opening bottle.
Monitoring Parameters
Seizure frequency, serum sodium as deemed necessary (particularly during first 3 months of therapy), symptoms of CNS depression (dizziness, headache, somnolence). Additional serum sodium monitoring recommended during maintenance treatment in patients receiving other medications known to decrease sodium levels, in patients with signs/symptoms of hyponatremia, and in patients with an increase in seizure frequency or severity. Monitor for suicidality (eg, suicidal thoughts, depression, behavioral changes). Serum levels of concomitant antiepileptic drugs during titration as necessary.
Test Interactions
Thyroid function tests; may depress serum T4 without affecting T3 levels or TSH
Dietary Considerations
May be taken without regard to meals.
Patient Education
While using the medication, do not use alcohol. Maintain adequate hydration unless instructed to restrict fluid intake. You may experience drowsiness, dizziness, blurred vision, nausea, or vomiting. Report CNS changes, increase in seizure frequency or severity, mentation changes, suicide ideation, depression, changes in cognition or memory, persistent fever, acute fatigue, weakness, insomnia, muscle cramping, weakness, abdominal pain, rash or skin irritations, unusual bruising or bleeding (mouth, urine, stool), or swelling of extremities.
Geriatric Considerations
The elderly frequently use diuretics which theoretically may increase the risk of hyponatremia associated with oxcarbazepine use. Serum sodium should be monitored closely for the first 3 months when oxcarbazepine therapy is initiated.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Comment
Oxcarbazepine has been associated with psychomotor slowing, difficulty with concentration, speech or language problems, sedation, ataxia, and gait disturbances. Because this agent is the 10-keto analog of carbamazepine, it is often considered useful for the management of bipolar disorder. However, there is a paucity of research data supporting this usage.
Nursing: Physical Assessment/Monitoring
Assess complete allergy history (carbamazepine). Monitor therapeutic effectiveness (seizure activity, frequency, duration, type). Monitor for sedation, CNS changes, visual changes, and skin reactions. Dosage should be tapered when discontinuing to reduce risk of increased seizures. Teach patient safety and seizure precautions.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, oral: 300 mg/5 mL (250 mL)
Trileptal®: 300 mg/5 mL (250 mL) [contains ethanol, propylene glycol]
Tablet, oral: 150 mg, 300 mg, 600 mg
Trileptal®: 150 mg, 300 mg, 600 mg [scored]
Pricing: U.S. (www.drugstore.com)
Suspension (OXcarbazepine)
300 mg/5 mL (250): $147.99
Tablets (OXcarbazepine)
150 mg (30): $39.99
300 mg (60): $131.00
600 mg (60): $259.98
Tablets (Trileptal)
150 mg (60): $129.99
300 mg (60): $235.99
600 mg (60): $432.00
References
Carrazana E and Mikoshiba I, “Rationale and Evidence for the Use of Oxcarbazepine in Neuropathic Pain,” J Pain Symptom Manage, 2003, 25(5 Suppl):31-5.
Irving GA, “Contemporary Assessment and Management of Neuropathic Pain,” Neurology, 2005, 28;64(12 Suppl 3):21-7.
Myllynen P, Pienimaki P, Jouppila P, et al, “Transplacental Passage of Oxcarbazepine and its Metabolites in vivo,” Epilepsia, 2001, 42(11):1482-5.
Pratoomsri W, Yatham LN, Bond DJ, et al, "Oxcarbazepine in the Treatment of Bipolar Disorder: A Review," Can J Psychiatry, 2006, 51(8):540-5.
Rey E, Bulteau C, Motte J, et al, “Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy,” J Clin Pharmacol, 2004, 44(11):1290-300.
Suppes T, Dennehy EB, Hirschfeld RMA, et al, “The Texas Implementation of Medication Algorithms: Update to the Algorithms for the Treatment of Bipolar I Disorder,” J Clin Psychiatry, 2005, 66(7):870-86.
International Brand Names
Lexi-Comp.com
Last full review/revision January 2012
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