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Quick facts
- Drug class
- Anti-epileptic Agent [EPC]
- How it is given
- oral
- Type
- human prescription drug
- RxNorm ID
- 283536
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine oral suspension is indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: -Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years -Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
About this medicine
Oxcarbazepine is an AED available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5 H -dibenz[b,f]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine USP is a light orange to creamish white or off white powder. It is sparingly soluble in chloroform, soluble in acetic acid, practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine oral suspension, USP contains the following inactive ingredients: natural and artificial cherry flavor, colloidal silicon dioxide, malic acid, methyl paraben, noncrystallizing sorbitol solution, pregelatinized starch, propyl paraben, propylene glycol, purified water, saccharin sodium, sodium benzoate and xanthan gum. Hydrochloric acid solution or sodium hydroxide solution may be added for adjustment of pH. oxocarbazepine-os-structure
How it works
12.1 Mechanism of Action The pharmacological activity of oxcarbazepine is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine [see Clinical Pharmacology (12.3) ]. The precise mechanism by which oxcarbazepine and MHD exert their anti-seizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.
Who should not take it
Oxcarbazepine oral suspension is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see Warnings and Precautions (5.2, 5.3 )]. Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate ( 4, 5.2 )
Warnings and cautions
• Hyponatremia: Monitor serum sodium levels ( 5.1 ) • Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs ( 5.3 ) • Serious Dermatological Reactions: If occurs, consider discontinuation ( 5.4 ) • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.5 ) • Withdrawal of AEDs: Withdraw oxcarbazepine gradually ( 5.6 ) • Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machinery ( 5.7) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established ( 5.8 ) • Hematologic Events: Consider discontinuing ( 5.9 ) • Seizure Control During Pregnancy: Active metabolite may decrease ( 5.10 ) • Risk of Seizure Aggravation: Discontinue if occurs ( 5.11 ) 5.1 Hyponatremia Clinically significant hyponatremia (sodium < 125 mmol/L) can develop during oxcarbazepine use. In the 14 controlled epilepsy studies, 2.5% of oxcarbazepine-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies). Clinically significant hyponatremia generally occurred during the first 3 months of treatment with oxcarbazepine, although there were patients who first developed a serum sodium < 125 mmol/L more than 1 year after initiation of therapy. Most patients who developed hyponatremia were asymptomatic, but patients in the clinical trials were frequently monitored and some had their oxcarbazepine dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during postmarketing use. […]
Reported side effects
The following serious adverse reactions are described below and elsewhere in the labeling: • Hyponatremia [see Warnings and Precautions (5.1) ] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions (5.2) ] • Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions (5.3) ] • Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] • Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.7) ] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions (5.8) ] • Hematologic Events [see Warnings and Precautions (5.9) ] The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most Common Adverse Reactions in All Clinical Studies Adjunctive Therapy/Monotherapy in Adults Previously Treated With Other AEDs The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions with oxcarbazepine: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus tremor, and abnormal gait. Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse reaction. […]
Interactions with other medicines
• Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required ( 7.1) • Carbamazepine, Phenytoin, and Phenobarbital: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary ( 7.1 ) • Oral Contraceptive: Oxcarbazepine may decrease the effectiveness of hormonal contraceptives ( 7.3 ) 7.1 Effect of Oxcarbazepine on Other Drugs Phenytoin levels have been shown to increase with concomitant use of oxcarbazepine at doses greater than 1,200 mg/day [see Clinical Pharmacology (12.3) ]. Therefore, it is recommended that the plasma levels of phenytoin be monitored during the period of oxcarbazepine titration and dosage modification. A decrease in the dose of phenytoin may be required. 7.2 Effect of Other Drugs on Oxcarbazepine Strong inducers of cytochrome P450 enzymes and/or inducers of UGT (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma/serum levels of MHD, the active metabolite of oxcarbazepine (25% to 49%) [see Clinical Pharmacology (12.3) ]. If oxcarbazepine and strong CYP3A4 inducers, or UGT inducers are administered concurrently, it is recommended that the plasma levels of MHD be monitored during the period of oxcarbazepine titration. Dose adjustment of oxcarbazepine may be required after initiation, dosage modification, or discontinuation of such inducers. 7.3 Hormonal Contraceptives Concurrent use of oxcarbazepine with hormonal contraceptives may render these contraceptives less effective [see Use in Specific Populations (8.3) and Clinical Pharmacology (12.3) ]. Studies with other oral or implant contraceptives have not been conducted.
Use in specific groups
• Pregnancy: May cause fetal harm ( 8.1 ) 8.1 Pregnancy Risk Summary Although oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans, available human data from published literature and ongoing pregnancy registry studies on use of oxcarbazepine during pregnancy have not demonstrated an increased prevalence of major congenital malformationswith first trimester exposure. However, all published studies reviewed have important methodological limitations, including unmeasured confounding and a small number of exposed cases (see Data). There are risks to the mother and fetus associated with partial onset seizures (see Clinical Considerations). There are no data on the risks associated with the use of oxcarbazepine and miscarriage or other adverse maternal outcomes. Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose (MRHD). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. All pregnancies have abackground risk of birth defect , loss, or other adverse outcomes. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Epilepsy, with or without exposure to antiepileptic drugs, has been associated with several adverse outcomes during pregnancy, including preeclampsia, preterm labor, antepartum and postpartum hemorrhage, placental abruption, poor fetal growth, prematurity, fetal death, and maternal mortality. The risk of maternal or fetal injury may be greatest for patients with untreated or poorly controlled convulsive seizures. Women with epilepsy who become pregnant should not abruptly discontinue antiepileptic drugs, including oxcarbazepine, due to the risk of status epilepticus or severe seizures, which may be life-threatening [ see Warnings and Precautions (5.6) ]. […]
If too much is taken
10.1 Human Overdose Experience Isolated cases of overdose with oxcarbazepine have been reported. The maximum dose taken was approximately 48,000 mg. All patients recovered with symptomatic treatment. Nausea, vomiting, somnolence, aggression, agitation, hypotension, and tremor each occurred in more than one patient. Coma, confusional state, convulsion, dyscoordination, depressed level of consciousness, diplopia, dizziness, dyskinesia, dyspnea, QT prolongation, headache, miosis, nystagmus, overdose, decreased urine output, and blurred vision also occurred. 10.2 Treatment and Management There is no specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Removal of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 18 November 2024. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.