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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Trileptal
Generic Name
Oxcarbazepine
Active Ingredient
OxcarbazepineCategory
Anti-epileptic Agent [EPC]
Variants
4
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Trileptal, you must consult a qualified healthcare professional.
| 150 mg/1 | TABLET, FILM COATED | ORAL | 0078-0456 |
Detailed information about Trileptal
Oxcarbazepine is an anti-epileptic agent (EPC) used primarily for the treatment of partial-onset seizures in adults and children. It works by stabilizing hyperexcited nerve membranes to prevent seizure activity.
For adult patients, the dosing of oxcarbazepine is typically individualized based on clinical response and tolerability.
Pediatric dosing is strictly weight-based to ensure safety and efficacy.
In patients with severe renal impairment (Creatinine Clearance < 30 mL/min), the starting dose should be reduced by 50%. Titration should be performed more slowly and with careful monitoring to avoid toxicity, as the active metabolite (MHD) is cleared by the kidneys.
No dosage adjustment is typically required for patients with mild to moderate hepatic impairment. However, oxcarbazepine has not been extensively studied in patients with severe hepatic impairment, and caution is advised in this population.
Lower starting doses and slower titration may be considered for elderly patients, primarily because they are at a higher risk for hyponatremia (low sodium levels) and age-related declines in renal function.
Oxcarbazepine should be taken exactly as prescribed by a healthcare provider.
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next scheduled dose, skip the missed dose and resume the regular schedule. Do not double the dose to catch up, as this increases the risk of side effects like extreme drowsiness or coordination loss.
Signs of oxcarbazepine overdose include extreme drowsiness, dizziness, nausea, vomiting, blurred vision, reduced consciousness, and difficulty breathing. In the event of a suspected overdose, contact emergency services or a poison control center immediately. Treatment is generally supportive, as there is no specific antidote for oxcarbazepine overdose.
> Important: Follow your healthcare provider's dosing instructions precisely. Do not adjust your dose or stop taking the medication without medical guidance, as sudden discontinuation can trigger status epilepticus (prolonged seizures).
Most side effects of oxcarbazepine occur during the initial titration phase and may diminish as the body adjusts to the medication. Common side effects include:
Oxcarbazepine is a potent neurological medication that requires careful monitoring. It is not a simple 'as-needed' drug; it must be taken consistently to maintain a therapeutic level in the bloodstream. Patients should be aware that oxcarbazepine can impair cognitive and motor performance. Caution is advised when performing tasks that require mental alertness, such as driving or operating heavy machinery, until the individual's response to the drug is well-established.
No FDA black box warnings for Oxcarbazepine. However, it carries significant warnings regarding suicidal ideation and serious skin reactions that carry nearly the same clinical weight as a black box warning.
Patients who have had a hypersensitivity reaction to carbamazepine have a 25% to 30% chance of experiencing a similar reaction to oxcarbazepine. If signs of a rash, hives, or swelling occur, the medication must be discontinued immediately under medical supervision.
While there are few absolute contraindications, certain drugs should not be used with oxcarbazepine due to severe risks:
Oxcarbazepine must NEVER be used in the following circumstances:
These conditions require a careful risk-benefit analysis by a specialist:
Oxcarbazepine is classified by the FDA as Pregnancy Category C. This means that animal studies have shown adverse effects on the fetus, but there are no adequate, well-controlled studies in humans. Data from pregnancy registries suggest that oxcarbazepine may be associated with a risk of congenital malformations, such as cleft palate or cardiac defects, although the risk appears lower than with older AEDs like valproate.
Oxcarbazepine and its active metabolite (MHD) are excreted into human breast milk. The milk-to-plasma ratio is approximately 0.5 to 0.8. While many infants do not show adverse effects, there is a risk of drowsiness, poor feeding, or irritability in the nursing infant. The decision to breastfeed should be made by weighing the benefits of breastfeeding against the potential risk of infant drug exposure.
Oxcarbazepine functions primarily as a prodrug. Upon ingestion, it is rapidly reduced by cytosolic aryl ketone reductase enzymes in the liver to its active 10-monohydroxy derivative (MHD). The primary pharmacological activity is attributed to MHD.
The core mechanism is the blockade of voltage-sensitive sodium channels. During a seizure, neurons fire rapidly and repetitively. MHD binds to the sodium channels when they are in their inactive state, prolonging the time the channel remains closed. This prevents the high-frequency repetitive firing of action potentials without interfering with normal, low-frequency neuronal activity. Additionally, MHD has been shown to inhibit high-voltage-activated N-type and P-type calcium channels and increase potassium conductance, both of which further stabilize the neuronal environment.
The pharmacodynamic effect of oxcarbazepine is directly related to the plasma concentration of MHD. There is a clear dose-response relationship for both seizure control and side effects. The onset of action for seizure reduction can be seen within a few days of reaching a therapeutic dose, though full stabilization often takes 2 to 4 weeks. Tolerance to the anticonvulsant effects does not typically develop, but patients may develop tolerance to the sedative side effects over time.
Common questions about Trileptal
Oxcarbazepine is primarily used to treat partial-onset seizures in adults and children as young as 2 years old. It can be used alone as monotherapy or in combination with other medications as adjunctive therapy. While its main indication is epilepsy, some doctors may prescribe it off-label for mood stabilization in bipolar disorder or for nerve pain like trigeminal neuralgia. It works by stabilizing the electrical activity in the brain to prevent the spread of seizure signals. Always use this medication only for the condition specifically diagnosed by your healthcare provider.
The most frequently reported side effects include dizziness, drowsiness (somnolence), double vision (diplopia), nausea, and vomiting. Many of these symptoms occur shortly after starting the medication or when the dose is increased and often improve as your body adjusts. Some patients also experience fatigue or problems with coordination and balance. If these side effects are severe or do not go away, you should contact your doctor. It is important to avoid driving until you know how the medication affects your alertness.
It is strongly recommended to avoid or strictly limit alcohol consumption while taking oxcarbazepine. Both alcohol and oxcarbazepine depress the central nervous system, and combining them can lead to dangerous levels of sedation, dizziness, and respiratory depression. Alcohol can also lower the seizure threshold, potentially making your medication less effective and increasing the risk of a breakthrough seizure. Discuss your alcohol intake honestly with your doctor to understand the specific risks for your situation. Safety should always be the priority when managing a seizure disorder.
Oxcarbazepine is considered a Category C medication, meaning there are potential risks to the fetus that must be weighed against the benefits of seizure control. Seizures during pregnancy can be dangerous for both the mother and the baby, so stopping the medication abruptly is not recommended. Data suggests a slight increase in the risk of birth defects, though this risk is generally lower than with some older seizure drugs. If you are pregnant or planning to become pregnant, your doctor will likely monitor your blood levels closely and recommend folic acid supplements. You should join a pregnancy registry to help researchers better understand these risks.
While oxcarbazepine begins to be absorbed and converted to its active form within hours, it may take several days or even weeks to feel the full therapeutic effect. Most doctors start with a low dose and gradually increase it (titration) to minimize side effects, which means it can take 2 to 4 weeks to reach the optimal maintenance dose. You may still experience seizures during this initial period. It is crucial to continue taking the medication exactly as prescribed even if you do not see immediate results. Consistent blood levels are the key to long-term seizure management.
No, you should never stop taking oxcarbazepine suddenly unless specifically directed by your doctor in an emergency (such as a severe rash). Abruptly discontinuing any anti-epileptic drug can cause 'rebound' seizures that are more frequent or severe than your original ones, including a life-threatening condition called status epilepticus. If the medication needs to be stopped due to side effects or lack of efficacy, your doctor will provide a tapering schedule to slowly reduce the dose over several weeks. This allows your brain to adjust safely to the change in chemistry. Always consult your neurologist before making any changes to your regimen.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. Never take two doses at once to make up for a missed one, as this significantly increases the risk of toxic side effects like extreme dizziness or confusion. To help prevent missed doses, try using a pillbox or setting a daily alarm on your phone. If you miss multiple doses in a row, contact your healthcare provider immediately for guidance on how to resume treatment safely.
Weight gain is not considered a common side effect of oxcarbazepine, especially when compared to other anti-epileptic drugs like valproate or gabapentin. In clinical trials, most patients experienced weight neutrality. However, every individual reacts differently to medication, and some people may notice changes in appetite or fluid retention. If you notice significant or rapid weight changes, it is worth discussing with your doctor to rule out other causes, such as thyroid issues or hyponatremia (low sodium). Maintaining a balanced diet and regular exercise is always recommended while on chronic medication.
Oxcarbazepine can interact with several other drugs, so it is vital to provide your doctor with a full list of everything you take. It is known to make hormonal birth control less effective, requiring a backup method like condoms. It can also interact with other seizure medications like phenytoin or phenobarbital, requiring dose adjustments. Certain diuretics (water pills) can increase the risk of low sodium levels when taken with oxcarbazepine. Always check with a pharmacist before starting any new over-the-counter supplements or herbal remedies like St. John's Wort.
Yes, oxcarbazepine is widely available as a generic medication in both tablet and oral suspension forms. Generic versions are required by the FDA to have the same active ingredient, strength, and effectiveness as the brand-name version (Trileptal). Using the generic form can significantly reduce the cost of treatment for most patients. However, some neurologists prefer that patients stay on the same manufacturer's version once a stable blood level is reached to avoid minor fluctuations in absorption. If your pharmacy changes your generic manufacturer, keep a close eye on any changes in seizure frequency or side effects.
Other drugs with the same active ingredient (Oxcarbazepine)
> Warning: Stop taking Oxcarbazepine and call your doctor immediately if you experience any of these serious symptoms.
With prolonged use, oxcarbazepine may impact bone health. Some studies suggest that long-term use of anticonvulsants can lead to decreased bone mineral density, potentially increasing the risk of osteopenia or osteoporosis. Patients on long-term therapy should discuss Vitamin D and Calcium supplementation with their healthcare provider. Additionally, chronic hyponatremia, even if mild, can lead to cognitive impairment or gait instability in elderly patients over time.
There are currently no FDA black box warnings specifically for oxcarbazepine. However, the FDA requires a general warning for all antiepileptic drugs regarding the increased risk of suicidal thoughts and behaviors. Additionally, there is a strong warning regarding serious dermatological reactions, particularly in patients of Asian descent who may carry the HLA-B*1502 allele. Testing for this allele is recommended prior to starting therapy in high-risk populations.
Report any unusual symptoms or changes in your health to your healthcare provider immediately to ensure safe management of your treatment.
Approximately 2.5% of patients taking oxcarbazepine develop low blood sodium levels. This risk is highest during the first three months of treatment. Patients taking other medications that lower sodium (like diuretics or NSAIDs) are at an even higher risk. Sodium levels should be checked periodically, especially if symptoms like confusion or lethargy develop.
Antiepileptic drugs, including oxcarbazepine, increase the risk of suicidal thoughts or behavior in about 1 in 500 patients. This risk can appear as early as one week after starting the drug. Caregivers should monitor for new or worsening depression, anxiety, agitation, or any unusual changes in behavior.
Rare cases of pancytopenia, agranulocytosis, and aplastic anemia have been reported. While routine blood monitoring is not always mandated for every patient, any signs of unexplained bruising, fever, or sore throat should be reported to a doctor immediately.
Healthcare providers typically order the following tests to ensure safety:
Oxcarbazepine commonly causes dizziness and somnolence. Patients should not drive, ride a bike, or operate complex machinery until they are certain the medication does not impair their coordination or judgment. This is particularly critical during the first few weeks of therapy or after any dose increase.
Alcohol should be avoided or strictly limited while taking oxcarbazepine. Alcohol can significantly worsen the sedative effects of the drug, leading to dangerous levels of respiratory depression or extreme lack of coordination.
Oxcarbazepine must never be stopped abruptly. Sudden withdrawal can cause a 'rebound' effect, leading to more frequent and severe seizures, including status epilepticus. If the drug must be stopped, it should be tapered slowly over several weeks under the direct supervision of a neurologist.
> Important: Discuss all your medical conditions, including kidney disease, liver disease, or a history of depression, with your healthcare provider before starting Oxcarbazepine.
Oxcarbazepine can interfere with certain laboratory tests:
For each major interaction, the mechanism usually involves the induction or inhibition of metabolic enzymes. Management strategies typically involve dose adjustments of the interacting drug or increased clinical monitoring of blood levels and symptoms.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, as polypharmacy is common in seizure management and requires expert oversight.
The chemical structure of oxcarbazepine is very similar to carbamazepine (Tegretol). This similarity means that the immune system may recognize both drugs as the same threat. If a patient has experienced a skin rash, liver inflammation, or blood count changes while taking carbamazepine, there is a significant risk that oxcarbazepine will trigger the same response. Patients must inform their doctor of any past 'bad reactions' to any seizure medications.
> Important: Your healthcare provider will evaluate your complete medical history, including genetic testing if necessary, before prescribing Oxcarbazepine to ensure your safety.
Oxcarbazepine is approved for use in children as young as 2 years for adjunctive therapy and 4 years for monotherapy.
Elderly patients (over 65) are at a significantly higher risk for oxcarbazepine-induced hyponatremia.
In patients with a Creatinine Clearance (CrCl) less than 30 mL/min, the elimination of the active metabolite is significantly impaired. The starting dose must be halved (e.g., 300 mg/day instead of 600 mg/day) and titration should occur at weekly intervals to allow the drug to reach a steady state without causing toxicity.
For mild to moderate hepatic impairment (Child-Pugh Class A and B), no dose adjustment is necessary. Oxcarbazepine has not been studied in severe hepatic impairment (Child-Pugh Class C), and its use in this population is generally not recommended unless the clinical need is critical.
> Important: Special populations require individualized medical assessment and frequent follow-up to ensure the medication remains both safe and effective.
| Parameter | Value |
|---|---|
| Bioavailability | >95% (Rapidly absorbed) |
| Protein Binding | ~40% (MHD) |
| Half-life | 2 hours (Parent); 9 hours (MHD) |
| Tmax | 4 to 6 hours (MHD) |
| Metabolism | Liver (reduction to MHD, then glucuronidation) |
| Excretion | Renal >95%, Fecal <4% |
Oxcarbazepine is classified as a dibenzazepine anticonvulsant. It is closely related to carbamazepine and eslicarbazepine acetate. Within the broader therapeutic area of neurology, it is considered a 'sodium channel blocker' antiepileptic drug.