By Peter Haeberli, J.D.
Medically Reviewed by Dr. Bob Mittleman
Last Update: August 13, 2024
Trileptal (Oxcarbazepine) is an anticonvulsant medication used to treat seizures and epilepsy in adults and children over 2 years old. The drug can be used alone or together with other medicines.
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Generic Trileptal is a tested and safe drug but it’s necessary to use it correctly in order to avoid negative reactions. Carefully read the instructions for use below.
- Indications
- Dosage and instructions for use
- Overdose
- Contraindications
- Side Effects
- Drug Interactions
- Special Precautions
- Storage
Product info
Indications
Trileptal is used in the following cases:
- Simple, complex partial epileptic seizures, with or without secondary generalization in adults and children aged 1 month and older;
- Generalized tonic-clonic epileptic seizures in adults and children aged 2 years and older.
- Trileptal is the first line preparation for monotherapy or as part of a combination therapy. This drug can be used to replace other antiepileptic drugs in those cases where the application of the latter does not achieve a satisfactory therapeutic response to treatment.
Dosage and instructions for use
The drug can be used as a monotherapy, or in combination with other antiepileptic drugs. In both cases, The treatment starts with a clinically effective dose, the frequency of administration is 2 times a day. The dose may be increased depending on the response to therapy. If another antiepileptic drug is replaced with Trileptal, the dose of the drug being replaced should be gradually reduced at the start of Trileptal therapy.
When the medication is used as part of combination therapy, a dose reduction of concomitant antiepileptic drugs and/or a slower increase in oxcarbazepine dose may be required.
The drug can be taken regardless of food intake (during, after meals or in between meals).
The following recommendations apply to patients with normal renal function.
For this category of patients, there is no need to monitor plasma concentrations of the active substance in order to optimize the therapy.
The tablets can be divided into 2 parts to facilitate swallowing.
In applying Trileptal in children under 3 years of age who are unable to swallow tablets, and in those cases when it is impossible to measure out the desired dose when using the drug in tablet form, the drug administered in the form of a suspension for ingestion.
Adults and elderly patients
- Monotherapy: The initial dose is 600 mg per day (8-10 mg/kg body weight per day), divided into 2 doses. A good therapeutic response was observed in the dose range of 600-2400 mg per day. If necessary, a gradual increase in the dose is possible. The dose can be increased no more than 600 mg/day with an interval of approximately 1 week until the desired therapeutic response is achieved. Under steady-state conditions, there is the experience of rapidly increasing the dose to 2,400 mg per day for 48 hours;
- Combined therapy: The initial dose of Trileptal is 600 mg per day (8-10 mg/kg body weight per day), divided into 2 doses. A good therapeutic response was observed in the dose range of 600-2400 mg per day. If necessary, a gradual increase in the dose is possible. The dose is increased no more than 600 mg/day with an interval of about 1 week until the desired therapeutic response is achieved.
The use of daily doses of more than 2,400 mg has not been studied. There is limited experience with using a daily dose of up to 4200 mg.
Special correction of the dosing regimen for elderly patients is not required since the therapeutic dose of the drug is set individually.
Children
With Trileptal monotherapy and combination therapy, the recommended initial dose of 8-10 mg/kg of body weight per day is divided into 2 doses.
To achieve the desired therapeutic effect, it’s possible to gradually increase the dose – at intervals of about 1 week – up to 10 mg/kg/day, up to a maximum daily dose rate of 60 mg/kg body weight.
When the medication is used in the form of monotherapy and as part of a combination therapy, with an adjustment for body weight, the apparent clearance in children is significantly reduced with age. Children aged 1 month to 4 years may require a dose 2 times exceeding the dose for adults when adjusted for body weight; Children between the ages of 4 and 12 may require a dose that exceeds the adult dose by 50% when adjusted for body weight.
In children between the ages of 1 month to 4 years, the impact of anti-epileptic drugs – inducers of liver enzymes in their apparent clearance is more pronounced than in children of older age groups (when adjusting for body weight). Children of older age groups, in combined therapy with Trileptal with liver enzyme inducers may need a slight increase in the dose of the drug compared with monotherapy.
In children less than three years old, the drug should be administered in the form of a syrup due to the difficulties of using solid dosage forms in this age group.
Patients with hepatic impairment
There is no need for correction of the dosing regimen in patients with mild or moderate impairment of liver function.
Patients with impaired renal function
For patients with impaired renal function (creatinine clearance less than 30 ml/min), the recommended initial dose is 300 mg/day; an increase in the dose should be slow until the desired therapeutic response is achieved.
Overdose
There are rare reports of an overdose of oxcarbazepine. The maximum dose reported was approximately 24,000 mg. After the symptomatic treatment in all cases, recovery was achieved.
- Symptoms: drowsiness, dizziness, nausea, vomiting, hyperkinesia, hyponatremia, ataxia, nystagmus;
- Treatment: There is no specific antidote. Conduct symptomatic and supportive treatment. To reduce the absorption of oxcarbazepine, gastric lavage is performed and activated charcoal intake is prescribed.
Contraindications
- Hypersensitivity;
- Breastfeeding period;
- Allergic reactions to the drug in the anamnesis;
- Pregnancy;
- Age under 2 years.
Side Effects
Side effects are usually mild or moderate and are observed mainly at the beginning of therapy.
- the body as a whole: increased fatigue; asthenia; angioneurotic edema, multiple organ hypersensitivity reactions (rash, fever, lymphadenopathy, increased liver function tests, eosinophilia, arthralgia);
- CNS: dizziness, headache, drowsiness; agitation, amnesia, apathy, ataxia, impaired concentration, confusion, depression, emotional lability, nystagmus, tremor;
- cardiovascular system: disturbance of rhythm and conduction (AV-blockade);
- digestive system: nausea, vomiting; constipation, abdominal pain, diarrhea; increased serum transaminases and/or alkaline phosphatase, hepatitis;
- hemopoiesis: leukopenia, thrombocytopenia;
- metabolism: hyponatremia; symptomatic hyponatremia, leading to seizures, confusion, encephalopathy, visual disturbances (blurred vision);
- dermatological reactions: acne, alopecia, rash; hives, Stevens-Johnson syndrome, systemic lupus erythematosus;
- sense organs: diplopia; foggy vision, dizziness.
Drug Interactions
- Trileptal and its active metabolite are inhibitors of cytochrome CYP2C19, simultaneous administration of high doses of oxcarbazepine and drugs metabolized by CYP2C19 (phenobarbital, phenytoin) may lead to interaction;
- The drug and its active metabolite are inducers of CYP3A4, CYP3A5, and CYP2B, involved in the metabolism of dihydropyridine derivatives of calcium channel blockers, oral contraceptives and antiepileptic drugs (including carbamazepine). Simultaneous administration of oxcarbazepine and substrates CYP3A4 and CYP3A5 can reduce the concentration of the latter in blood plasma. Oxcarbazepine can reduce the carbamazepine concentration by 22%; At the same time, carbamazepine can reduce the concentration of oxcarbazepine by 40%;
- Valproic acid can reduce the concentration of oxcarbazepine by 18%;
- The drug enhances the sedative effect of ethanol.
Special Precautions
When Trileptal was used in clinical practice, in particular cases (post-marketing reports), development of immediate-type hypersensitivity (type I) was noted, including rash, itching, hives, angioedema and anaphylactic reactions.
Angioedema and anaphylactic reactions with lesions of the larynx, vocal folds (area of the glottis), lips, eyelids developed both at the first and with the repeated reception of this drug. In the case of developing an immediate type of hypersensitivity, the therapy should immediately be canceled. Consult a doctor for an alternative therapy.
Caution should be taken when using the drug in patients with known hypersensitivity to carbamazepine since in this group of patients, in about 25-30% of cases, the development of hypersensitivity reactions to oxcarbazepine is possible. Patients who have no history of hypersensitivity to carbamazepine may also have hypersensitivity reactions to the drug, including polyorganism disorders.
The use of the remedy in patients with severe impairment of liver function has not been studied, so it is necessary to use the drug with caution in this category of patients.
Experience with Trileptal during pregnancy is limited. The available reports indicate a possible connection of the drug during pregnancy with the development of birth defects (for example, the wolf mouth). In experimental studies, when using the preparation in toxic doses, there was an increase in embryonic mortality, slowing and disrupting the development and growth of the fetus. If a patient plans to become pregnant or becomes pregnant during the use of the drug, and if there is a question about using Trileptal during pregnancy, it is necessary to carefully compare the expected benefits of therapy and the possible risk to the fetus, especially in the first trimester of pregnancy.
The use of the drug in children under 1 month of age has not been studied.
Storage
The drug should be stored out of reach of children at a temperature of no higher than 86° F, in the original packaging, without special precautions. Shelf life is 3 years. Do not use the preparation after the expiration date printed on the package.
About the Author
Peter Haeberli, J.D., joined Merck after its acquisition of Sirna Therapeutics in 2006, where he was Director of Intellectual Property and played a key role in developing the company’s IP portfolio. He originally joined Sirna’s predecessor, Ribozyme Pharmaceuticals, as a research chemist in 1993 before transitioning to the legal department in 1999, eventually taking on increasing responsibilities through the company’s restructuring and relaunch in 2003. Prior to his work at Ribozyme, he was a chemist at Ciba-Geigy Corp. Mr. Haeberli holds a B.A. in Molecular, Cellular, and Developmental Biology from the University of Colorado, Boulder, and a J.D. from the University of Denver. He is licensed to practice law in California and Colorado, and is admitted before the U.S. Patent and Trademark Office.
Disclaimer: The information presented is for informational purposes only and should not be considered as medical advice. It is essential to consult a qualified healthcare provider before making any healthcare or medication decisions. This content is not a substitute for professional medical advice, diagnosis, or treatment.