What is trileptal used for. Trileptal (Oxcarbazepine) for Bipolar Disorder: Uses, Dosage, and Side Effects
What is Trileptal used for in bipolar disorder treatment. How does Trileptal work as a mood stabilizer. What are the potential side effects of Trileptal. Is Trileptal safe for pregnant women or nursing mothers. How does Trileptal compare to other bipolar medications.
Understanding Trileptal: An Anticonvulsant for Bipolar Disorder
Trileptal, known generically as oxcarbazepine, is a medication that has found its place in the treatment of bipolar disorder. Originally approved by the U.S. Food and Drug Administration (FDA) in 2000 as an anticonvulsant for seizure disorders, Trileptal has since been utilized off-label as a mood stabilizer for individuals struggling with bipolar disorder.
Bipolar disorder is a complex mental health condition characterized by extreme mood swings, including manic highs and depressive lows. The use of anticonvulsants like Trileptal in treating bipolar disorder stems from the observation that these medications can help stabilize mood fluctuations.
How does Trileptal work in bipolar disorder?
Trileptal works by modulating sodium channels in the brain, which helps to stabilize neural activity. This mechanism of action is believed to contribute to its mood-stabilizing effects in bipolar disorder. By calming overactive brain circuits, Trileptal may help reduce the frequency and intensity of manic and depressive episodes.
Trileptal Dosage and Administration
The dosage of Trileptal prescribed for bipolar disorder can vary depending on several factors, including the patient’s age, overall health, and the severity of their symptoms. It’s crucial to follow the dosing instructions provided by a healthcare professional.
What is the typical dosage for Trileptal in bipolar disorder?
While dosages can vary, a common starting dose for adults with bipolar disorder might be 300 mg twice daily, gradually increased to a target dose of 600-1200 mg per day, divided into two doses. However, some patients may require higher doses for optimal symptom control.
It’s important to note that Trileptal should be taken consistently, even when symptoms improve. Abruptly stopping the medication can lead to withdrawal symptoms or a recurrence of bipolar symptoms.
Can I miss a dose of Trileptal?
If you miss a dose of Trileptal, it’s best to take it as soon as you remember. However, if it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Never double up on doses to make up for a missed one, as this can increase the risk of side effects.
Side Effects and Safety Considerations of Trileptal
Like all medications, Trileptal can cause side effects. While not everyone experiences side effects, it’s important to be aware of potential adverse reactions.
What are the common side effects of Trileptal?
Common side effects of Trileptal may include:
- Dizziness
- Drowsiness
- Fatigue
- Nausea
- Vomiting
- Headache
- Double vision or blurred vision
- Tremor
- Problems with coordination and balance
- Skin rash
Most of these side effects are mild and tend to improve as your body adjusts to the medication. However, if side effects persist or worsen, it’s important to consult your healthcare provider.
Are there any serious side effects to be aware of?
While rare, Trileptal can cause more serious side effects that require immediate medical attention. These may include:
- Severe skin reactions (such as Stevens-Johnson syndrome)
- Hyponatremia (low sodium levels in the blood)
- Suicidal thoughts or behaviors
- Liver problems
- Severe allergic reactions
If you experience any signs of these serious side effects, such as severe rash, swelling of the face or tongue, unusual bruising or bleeding, yellowing of the skin or eyes, or thoughts of self-harm, seek medical help immediately.
Trileptal and Pregnancy: Important Considerations
The use of Trileptal during pregnancy requires careful consideration and should be discussed thoroughly with a healthcare provider.
Is Trileptal safe during pregnancy?
Trileptal may pose risks to a developing fetus, particularly in the first trimester. Studies have shown an increased risk of congenital malformations, including craniofacial defects and cardiac abnormalities, in infants exposed to oxcarbazepine during pregnancy.
However, the decision to continue or discontinue Trileptal during pregnancy should be made on an individual basis, weighing the potential risks to the fetus against the risks of untreated bipolar disorder to both the mother and the developing baby.
Can Trileptal be used while breastfeeding?
Trileptal can pass into breast milk, potentially affecting a nursing infant. While some studies suggest that the amount transferred is relatively small and unlikely to cause harm, others have reported adverse effects in breastfed infants. As with pregnancy, the decision to use Trileptal while breastfeeding should be made in consultation with a healthcare provider, considering the benefits of breastfeeding and the importance of the medication for the mother’s health.
Trileptal Interactions: What You Need to Know
Trileptal can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects.
Which medications interact with Trileptal?
Some medications that may interact with Trileptal include:
- Other anticonvulsants (e.g., carbamazepine, phenytoin)
- Hormonal contraceptives
- Calcium channel blockers
- Some antidepressants
- Diuretics
- Proton pump inhibitors
It’s crucial to inform your healthcare provider about all medications, supplements, and herbal products you’re taking to avoid potential interactions.
Does Trileptal interact with alcohol?
While Trileptal doesn’t directly interact with alcohol, combining the two can increase the risk of side effects such as dizziness, drowsiness, and impaired coordination. It’s generally advisable to avoid alcohol while taking Trileptal or to consume it only in moderation after consulting with your healthcare provider.
Comparing Trileptal to Other Bipolar Medications
Trileptal is one of several medications used in the treatment of bipolar disorder. Understanding how it compares to other options can help patients and healthcare providers make informed decisions about treatment.
How does Trileptal compare to lithium?
Lithium is often considered the gold standard for bipolar disorder treatment, particularly for its effectiveness in preventing manic episodes and reducing suicide risk. Trileptal, while effective for some patients, has less robust evidence supporting its use in bipolar disorder compared to lithium.
However, Trileptal may be preferred in certain situations, such as when a patient cannot tolerate lithium’s side effects or has impaired kidney function. Trileptal also requires less frequent blood monitoring compared to lithium.
What about Trileptal versus other anticonvulsants?
Other anticonvulsants used in bipolar disorder include valproic acid, carbamazepine, and lamotrigine. Each of these medications has its own profile of efficacy, side effects, and monitoring requirements.
- Valproic acid is particularly effective for manic episodes and may work faster than Trileptal.
- Carbamazepine is chemically similar to Trileptal but may have more drug interactions and side effects.
- Lamotrigine is often used for bipolar depression and maintenance treatment, while Trileptal is more commonly used for manic or mixed episodes.
The choice between these medications depends on individual factors such as the specific symptoms being targeted, the patient’s medical history, and potential side effects.
Long-Term Use of Trileptal in Bipolar Disorder
For many individuals with bipolar disorder, long-term medication use is necessary to maintain mood stability and prevent recurrent episodes.
Is Trileptal effective for long-term bipolar disorder management?
While research on the long-term use of Trileptal specifically for bipolar disorder is limited, many patients find it helpful in managing their symptoms over extended periods. Some studies suggest that Trileptal may be particularly effective in preventing manic episodes when used as maintenance therapy.
However, the effectiveness of Trileptal can vary from person to person, and some individuals may need to switch to or add other medications over time to achieve optimal symptom control.
What are the considerations for long-term Trileptal use?
Long-term use of Trileptal requires ongoing monitoring and follow-up with a healthcare provider. This may include:
- Regular blood tests to check sodium levels and liver function
- Monitoring for potential long-term side effects
- Adjusting dosage as needed based on symptom control and tolerability
- Addressing any emerging health concerns that may be affected by or interact with Trileptal
It’s also important for patients to maintain open communication with their healthcare providers about any changes in their symptoms, side effects, or overall health while on long-term Trileptal therapy.
Trileptal in Special Populations
The use of Trileptal may require special considerations in certain populations, including children, elderly patients, and those with specific medical conditions.
Can children take Trileptal for bipolar disorder?
While Trileptal is approved for use in children with epilepsy, its use in pediatric bipolar disorder is less established. The safety and efficacy of Trileptal for bipolar disorder in children and adolescents have not been thoroughly studied.
If a child is prescribed Trileptal for bipolar symptoms, it’s crucial to closely monitor for side effects and effectiveness. Children may be more susceptible to certain side effects, such as behavioral changes or skin reactions.
What about Trileptal use in elderly patients?
Elderly patients may be more sensitive to the side effects of Trileptal, particularly dizziness, drowsiness, and hyponatremia. Dosage adjustments may be necessary, and closer monitoring of sodium levels is often recommended.
Additionally, because older adults are more likely to be taking multiple medications, the risk of drug interactions with Trileptal may be higher in this population.
Are there any medical conditions that preclude Trileptal use?
Certain medical conditions may require caution or contraindicate the use of Trileptal:
- Kidney disease: Trileptal is primarily eliminated through the kidneys, so dosage adjustments may be necessary for patients with impaired kidney function.
- Liver disease: While Trileptal is not extensively metabolized by the liver, severe liver disease may affect its clearance from the body.
- History of hyponatremia: Patients with a history of low sodium levels may be at increased risk when taking Trileptal.
- Cardiac conduction disorders: Trileptal may affect heart rhythm in some cases, so caution is advised in patients with pre-existing cardiac conduction abnormalities.
A thorough medical history and ongoing monitoring are essential to ensure safe and effective use of Trileptal in these special populations.
Trileptal (Oxcarbazepine) for Bipolar Disorder
What is Trileptal? Trileptal is a medication known as an anticonvulsant that is used to treat seizures. It is also sometimes used as a mood stabilizer to treat the symptoms of bipolar disorder.
When did the U.S. Food and Drug Administration (FDA) approve the medication? Trileptal was approved by the FDA in 2000.
Is there a generic version of Trileptal? Yes, the generic version is known as oxcarbazepine and is sold in the US.
Are there any major differences between Trileptal and other medications used to treat bipolar disorder? Trileptal belongs to the class of medications known as anticonvulsants. Anticonvulsants are sometimes prescribed to treat manic and depressive episodes associated with bipolar disorder. Trileptal may be prescribed in combination with other medications to treat symptoms. Talk to your doctor about the potential risks and benefits of taking Trileptal.
Can children take Trileptal? Children are prescribed Trileptal for seizures, but the effectiveness and safety of use for bipolar disorder has not been established. Talk to your child’s doctor about the risks and benefits and potential side effects to monitor.
Are there potential interaction issues for people taking Trileptal and any other drugs? There are hundreds of drugs which are known to interact with Trileptal in major, moderate, or mild ways, so let your doctor know what other medications you are taking before you begin taking the medication. Some of these might include amiodarone, amitriptyline, calcium channel blockers, chlorpromazine, clomipramine, cyclophosphamide, desmopressin, diazepam, diuretics, hormonal contraceptives, other anticonvulsants, proton-pump inhibitors, theophylline, and selective serotonin reuptake inhibitors. The medication can also decrease the effectiveness of hormonal contraceptives.
Are there any other medical conditions that would make someone ineligible for Trileptal therapy? Talk to your doctor about other medical conditions before you take Trileptal, such as kidney or liver disease.
What is the typical dose that would be prescribed to someone taking Trileptal? Dosage will vary depending on the age of the patient and the condition being treated.
What do I do if I miss a dose? You should never take extra doses of the medication to make up for missed doses. Talk to your doctor about how long you should wait in between doses.
What side effects can Trileptal cause? Common side effects can include:
cold symptoms
crying
lack of balance
changes in vision
dizziness
depressed mood
spinning sensation
uncontrolled eye movement
It also is recommended that you wait to drive or operate machinery until you know how the medication affects you. It is also recommended that people avoid alcohol and illegal drugs while on the medication, as they can worsen adverse effects. Report major side effects to your doctor immediately, which can include swelling, thirst, nausea, vomiting, headache, confusion, decreased alertness, rash, fever, blisters, irritated eyes, blotches on skin, yellowing of skin or eyes, bleeding or bruising, joint pain, chest pain, signs of infection, or changes in urination.
You can also report side effects to the FDA at 1-800-FDA-1088 or online.
What are the potential psychological side effects of taking Trileptal? Taking anticonvulsant medications can sometimes result in increased suicidal thoughts and behaviors in a small percentage of people. Seek medical help if you experience these thoughts or other changes in your behavior or mood.
Is it safe for a woman who is pregnant, about to become pregnant, or nursing to take Trileptal? Trileptal may cause birth defects and fetal harm when taken during pregnancy. The drug can be transferred via breast milk and potentially harm a baby. Therefore, talk to your doctor if you are pregnant, planning to become pregnant, or are nursing before you take Trileptal. The medication can also impact the effectiveness of hormonal contraceptives.
Can symptoms occur if Trileptal is discontinued? It’s important not to discontinue use of the drug before talking with your doctor. Withdrawal symptoms of Trileptal can include insomnia and return of seizures or bipolar symptoms (depending on the purpose of taking the medication).
What should I do if I overdose on Trileptal? An overdose of Trileptal could be fatal, so seek immediate help or call the Poison Help Line at 1-800-222-1222 if you overdose. Overdose symptoms can include dizziness, sedation, decreased heart rate, low blood pressure, low sodium levels, seizures, and coma.
Is Trileptal habit-forming? Trileptal is not habit-forming, but it is not recommended that you discontinue use of the drug before talking with your doctor, as withdrawal symptoms can occur.
How much does Trileptal cost? According to goodrx.com, 60 tablets of 300 mg generic oxcarbazepine cost approximately $86.50. Sixty tablets of 300 mg Trileptal cost approximately $160.66.
Are there any disadvantages to Trileptal? The biggest disadvantages of Trileptal are potential side effects. Pregnant women are also typically advised not to take the medication due to the risks.
DISCLAIMER: The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other healthcare providers.
This article mentions drugs that were FDA-approved and available at the time of publication and may not include all possible drug interactions or all FDA warnings or alerts. The author of this page explicitly does not endorse this drug or any specific treatment method. If you have health questions or concerns about interactions, please check with your physician or go to the FDA site for a comprehensive list of warnings.
Notes: This article was originally published January 2, 2017 and most recently updated September 12, 2022.
- FDA – Trileptal
- NIH – Oxcarbazepine
Our Review Process
Trileptal: Uses, Dosage & Side Effects
Generic name: oxcarbazepine [ ox-kar-BAY-zeh-peen ]
Drug class: Dibenzazepine anticonvulsants
Medically reviewed by Sanjai Sinha, MD. Last updated on Apr 1, 2022.
What is Trileptal?
Trileptal is an an anticonvulsant or antiepileptic medicine. It works by decreasing nerve impulses that cause seizures and pain.
Trileptal is used either alone or with other medicines to treat partial seizures.
Trileptal is used as a single medicine in adults and children who are at least 4 years old. It is used with other medicines in adults and children who are at least 2 years old.
Warnings
Do not stop using Trileptal suddenly.
Seek medical treatment if you have symptoms of a serious drug reaction: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising or bleeding, or yellowing of your skin or eyes.
Call your doctor right away if you have symptoms of low sodium levels in your body, such as nausea, confusion, severe weakness, muscle pain, or increased seizures.
Some people have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Before taking this medicine
You should not take Trileptal if you are allergic to oxcarbazepine or eslicarbazepine.
Tell your doctor if you have ever had:
liver disease;
kidney disease;
mood problems or suicidal thoughts; or
an allergy to carbamazepine (Carbatrol, Tegretol).
Some people have thoughts about suicide while taking oxcarbazepine. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Do not start or stop taking Trileptal during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking oxcarbazepine for seizures.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of oxcarbazepine on the baby.
Oxcarbazepine can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.
You should not breast-feed while you are taking Trileptal.
Do not give this medicine to a child without medical advice. There are specific age restrictions for the use of oxcarbazepine in children, depending on the dose form and whether it is used alone or with other medicines.
How should I take Trileptal?
Take Trileptal exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Shake the Trileptal oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Give the liquid directly from the oral syringe, or mix the medicine with a small glass of water. After using the syringe, rinse it with water and allow it to air dry.
You may take the Trileptal oral liquid or tablets with or without food.
You may need frequent blood tests.
Do not stop using oxcarbazepine suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.
In case of emergency, wear or carry medical identification to let others know you use Trileptal.
Seizures are often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.
Store at room temperature away from moisture and heat. Throw away any unused liquid 7 weeks after opening the bottle.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Do not drink alcohol. Drinking alcohol can increase certain side effects, and may increase the risk of seizures.
Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Trileptal side effects
Get emergency medical help if you have signs of an allergic reaction to Trileptal: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance.
Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased seizures.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Common Trileptal side effects may include:
dizziness, drowsiness, tiredness;
balance or coordination problems;
nausea, vomiting;
tremors or shaking;
double vision; or
rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Trileptal?
Using Trileptal with other drugs that make you drowsy can worsen this effect.
Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can interact with oxcarbazepine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Popular FAQ
Trileptal (oxcarbazepine) is an anticonvulsant medication used to treat partial-onset seizures. It is also used off-label as a mood stabilizer for the treatment of bipolar disorder. Withdrawal from Trileptal may take weeks or months and should be done following the advice of your healthcare provider. Continue reading
Trileptal (oxcarbazepine) can cause weight gain in adults and children, according to the results of clinical trials.
Other side effects of Trileptal include increased appetite, leg edema (swelling) and digestive changes such as constipation, which can all increase body weight. Continue reading
Trileptal works to stop partial-onset seizures and it may take days, weeks or even months to see if Trileptal is working for you to reduce the frequency of your seizures. The length of time patients were treated with Trileptal in clinical studies varied from days to almost 6 months.
If you are taking Trileptal off-label to treat bipolar disorder it may also take several weeks to tell if it is working for you. Continue reading
Oxtellar XR and Trileptal are two prescription medications that both contain the same active ingredient called oxcarbazepine. Both medications are taken by mouth and used in the treatment of partial-onset seizures, but they are made by different companies and come in different forms. Continue reading
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Copyright 1996-2023 Cerner Multum, Inc. Version: 10.09.
💊 Composition of Trileptal ® ✅ Use of Trileptal ® Keep it for yourself Look for alternatives Interaction Description of the active ingredients of the preparation Trileptal ® The scientific information provided is general and cannot be used to make decisions. Update date: 2020.05.07 Marketing authorization holder: NOVARTIS PHARMA, AG Manufactured:NOVARTIS PHARMA STEIN, AG (Switzerland) ATX code: N03AF02 (Oxcarbazepine) Active substance: Rec.INN registered by WHO Dosage form
Release form, packaging and composition |
, coated film coated, 600 mg: 10, 20, 30 or 50 pcs.
Pharmacological activity is primarily due to the action of the metabolite – monohydroxy derivative (MHP) oxcarbazepine. The mechanism of action of oxcarbazepine and its metabolite is mainly associated with the blockade of voltage-dependent sodium channels, which leads to stabilization of overexcited neuronal membranes, inhibition of the occurrence of serial neuronal discharges and a decrease in synaptic conduction of impulses.
After a single dose of oxcarbazepine, depending on the dosage form used, C max metabolite in plasma is 24.9-34 μmol / l, the average time to reach it is about 4.5-6 hours. Pharmacokinetic studies have shown that 2% oxcarbazepine and 70% MHD are determined in blood plasma; the rest is accounted for by secondary metabolites, rapidly excreted from the blood plasma.
Minor amounts of MHP (about 4% of the dose) are oxidized to form an inactive metabolite – 10, 11-dihydroxy derivative (DHP).
Weight-adjusted clearance in children aged 4 to 12 years is 43% higher than in adults. The estimated AUC of MHD in children of this age group is 2/3 of that in adults when using the same doses (when adjusted for body weight). It is assumed that in children aged 13 years and older, due to the increase in body weight, the clearance of MHD, adjusted for body weight, corresponds to the clearance of MHD in adults.
| G40 | Epilepsy |
Dosing regimen
The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.
Take orally.
Initial dose – 8-10 mg / kg body weight / day. Further, the dose is adjusted depending on the treatment regimen, the age of the patient, the effectiveness of treatment, and kidney function.
For patients with impaired renal function (CC less than 30 ml / min), adjustment of the initial dose and dosing regimen is required.
Side effects
Most common (≥ 10%) : drowsiness, headache, dizziness, diplopia, nausea, vomiting, fatigue.
From the side of the hematopoietic system: sometimes – leukopenia; very rarely – suppression of bone marrow hematopoiesis, agranulocytosis, aplastic anemia, neutropenia, pancytopenia, thrombocytopenia.
From the immune system: very rarely – hypersensitivity reactions accompanied by fever and rash (including multiple organ disorders). With the development of hypersensitivity reactions, it is possible to damage the circulatory and lymphatic systems (eosinophilia, thrombocytopenia, lymphadenopathy, splenomegaly), muscles and joints (myalgia, swelling in the joints, arthralgia), nervous system (encephalopathy), kidneys (proteinuria, interstitial nephritis, renal failure), lungs (shortness of breath, pulmonary edema, bronchospasm, interstitial inflammation), abnormal liver function, angio eurotic edema, anaphylactic reactions.
From the side of metabolism: often – hyponatremia; very rarely – clinically significant hyponatremia (sodium concentration <125 mmol / l - usually during the first 3 months of drug therapy; in some patients - more than 1 g after the start of treatment), leading to the development of such manifestations and symptoms as convulsive attacks, confusion, decreased level of consciousness, encephalopathy, visual disturbances (including blurred vision), nausea, vomiting, folic acid deficiency; very rarely - hypothyroidism.
From the side of the central nervous system: very often – drowsiness, headache, dizziness; often – ataxia, tremor, nystagmus, impaired attention, amnesia; confusion, depression, apathy, agitation, emotional lability.
From the senses: very often – diplopia; often – visual impairment, blurred vision, vertigo.
From the side of the cardiovascular system: very rarely – arrhythmias, AV blockade, arterial hypertension.
From the digestive system: very often – nausea, vomiting; often – diarrhea, constipation, abdominal pain; sometimes – an increase in the activity of liver enzymes, an increase in the concentration of alkaline phosphatase in the blood; very rarely – pancreatitis and / or increased levels of lipase and / or amylase, hepatitis.
Dermatological reactions: often – rash, alopecia, acne.
Allergic reactions: sometimes – urticaria; very rarely – angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme.
Other: very often – feeling tired; often – asthenia; very rarely – systemic lupus erythematosus.
In children under 4 years of age: very often (11%) – drowsiness; often (≥1%–<10%) - ataxia, irritability, vomiting, lethargy, fatigue, nystagmus, tremor, loss of appetite, increased concentration of uric acid in the blood.
Contraindications for use
Children under 3 years of age; hypersensitivity to oxcarbazepine.
Pregnancy and lactation
Limited experience with pregnancy. Reports suggest that oxcarbazepine use during pregnancy may be associated with the development of birth defects (eg, cleft palate).
In experimental studies with the use of oxcarbazepine in toxic doses, an increase in embryonic mortality, slowing and impaired development and growth of the fetus was noted. If the patient plans to become pregnant or becomes pregnant while using oxcarbazepine, and if there is a question about the use of oxcarbazepine during pregnancy, the expected benefits of therapy and the possible risk to the fetus, especially in the first trimester of pregnancy, should be carefully weighed.
Use the lowest effective dose of oxcarbazepine during pregnancy.
When clinically effective in women of childbearing age, oxcarbazepine should be used as monotherapy.
Effective antiepileptic treatment should not be interrupted during pregnancy, as disease progression may adversely affect the mother and fetus.
Folic acid deficiency is known to develop during pregnancy. Antiepileptic drugs can exacerbate this deficiency, which is one of the possible causes of fetal developmental disorders, so additional folic acid supplementation is recommended.
When used during pregnancy, it must be taken into account that the physiological changes occurring in the body of a pregnant woman can lead to a gradual decrease in the concentration of the active metabolite in the blood plasma. To achieve maximum control of the symptoms of the disease, it is necessary to regularly evaluate the clinical effect of oxcarbazepine and determine the concentration of the metabolite in the blood plasma.
Determination of the concentration of MHD in blood plasma is also recommended in the postpartum period, especially if the dose of oxcarbazepine was increased during pregnancy.
There are reports that the use of antiepileptic drugs during pregnancy can lead to increased bleeding in newborns. As a precautionary measure, it is recommended that vitamin K 1 be administered during the last few weeks of pregnancy and to newborns whose mothers received oxcarbazepine.
Oxcarbazepine and MHD cross the placental barrier and are excreted in breast milk. The concentration ratio in milk and plasma was 0.5 for both substances. Since the effect on newborns of oxcarbazepine and MHD, received with mother’s milk, is not known, oxcarbazepine should not be used during breastfeeding.
Precautions
Use with caution in patients with known hypersensitivity to carbamazepine, as in this group of patients, approximately 25-30% of cases may develop hypersensitivity reactions to oxcarbazepine.
In patients with no history of hypersensitivity to carbamazepine, it is also possible to develop hypersensitivity reactions to oxcarbazepine, including multiple organ disorders. In the event of an immediate hypersensitivity reaction, oxcarbazepine should be discontinued immediately and alternative therapy instituted.
Use with caution in patients with severe hepatic impairment.
In patients with impaired renal function and with low serum sodium concentrations, or in patients receiving concomitant treatment with drugs that promote the excretion of sodium from the body (diuretics, drugs that affect the secretion of ADH), the concentration of sodium in the blood serum should be determined before starting therapy with oxcarbazepine. In the future, the concentration of sodium in the blood serum should be monitored 2 weeks after the start of therapy and then monthly for 3 months or as needed. With particular attention to these risk factors should be treated in elderly patients.
If it is necessary to prescribe diuretics and other drugs that reduce the concentration of sodium in the blood serum, patients receiving oxcarbazepine should follow the same recommendations. If clinical symptoms appear that suggest hyponatremia, serum sodium concentration should be measured. For other patients, measurement of serum sodium concentration can be performed during routine blood tests.
If symptoms of severe bone marrow suppression develop, consideration should be given to discontinuing oxcarbazepine.
Patients receiving anticonvulsants rarely experienced episodes of suicidal behavior and thoughts. The mechanism of increased risk of suicide in this category of patients has not been established. Therefore, at all stages of treatment, careful monitoring of patients receiving oxcarbazepine is necessary.
Weight should be monitored in all patients with heart failure to detect fluid retention in a timely manner. With fluid retention or with the progression of symptoms of heart failure, the concentration of sodium in the blood serum should be determined.
If hyponatremia occurs, fluid intake should be limited. When using oxcarbazepine, in very rare cases, a violation of cardiac conduction is possible, therefore, during the period of treatment, careful monitoring of patients with previous conduction disorders (AV blockade, arrhythmia) is necessary.
Dermatological reactions have been observed in both children and adults with oxcarbazepine and developed on average 19 days after the start of treatment. There are isolated reports of recurrence of skin reactions when oxcarbazepine is restarted. With the development of skin reactions against the background of the use of oxcarbazepine, consideration should be given to its cancellation and the appointment of another antiepileptic agent.
If hepatitis is suspected, withdrawal of oxcarbazepine should be considered.
As with all antiepileptic drugs, oxcarbazepine should be discontinued gradually due to the risk of increased seizure frequency.
Influence on the ability to drive vehicles and mechanisms
Patients who experience dizziness, drowsiness or other disorders of the central nervous system during the use of oxcarbazepine should not drive vehicles or work with mechanisms during the period of treatment.
Drug interactions
Oxcarbazepine and its pharmacologically active metabolite MHD are inhibitors of cytochrome CYP2C19. Therefore, when using oxcarbazepine in high doses, drug interactions with drugs metabolized by CYP2C19 (phenobarbital, phenytoin) are possible. For some patients, dose reduction of drugs – substrates of CYP2C19 may be required. Oxcarbazepine and MHD have been shown to interact weakly or not at all with the following microsomal isoenzymes: CYP1A2, CYP2A6, CYP2C9, CYP2D9, CYP2E1, CYP4A4 and CYP4C11.
As inducers of CYP3A4 and CYP3A5, oxcarbazepine and MHD reduce plasma concentrations of drugs metabolized by these isoenzymes: dihydropyridine calcium antagonists, oral contraceptives, and antiepileptic drugs (eg, carbamazepine). With simultaneous use with oxcarbazepine, a decrease in plasma concentrations of other drugs that are substrates of CYP3A4 and CYP3A5 enzymes (for example, drugs of the immunosuppressant group – cyclosporine) is also possible.
Because MHD is a weak inducer of UDP-glucuronyl transferase in vitro, it is therefore unlikely to interfere in vivo with the metabolism of drugs excreted as glucuronic acid conjugates (eg, valproic acid and lamotrigine). But, taking into account even the weak inducing ability of oxcarbazepine and MHD, it may be necessary to increase the doses of concomitantly used drugs metabolized with the participation of CYP3A4 or UDP-glucuronyl transferase. If oxcarbazepine is discontinued, the dose of these drugs may need to be reduced.
In vitro studies have confirmed the weak inducing ability of oxcarbazepine and MHD against isoenzymes of the CYP2B and CYP3A4 enzyme subsystems. The inducing effect of oxcarbazepine and MHD on other CYP isoenzymes is unknown.
Plasma concentration of phenytoin increases by up to 40% with simultaneous use of oxcarbazepine at a dose of 1200 mg / day and above. Therefore, when using oxcarbazepine at such doses, a reduction in the dose of phenytoin may be required.
The increase in serum concentrations of phenobarbital with simultaneous use with oxcarbazepine is insignificant (15%).
Simultaneous administration of strong inducers of cytochrome P450 isoenzymes (ie carbamazepine, phenytoin and phenobarbital) reduces the concentration of MHD in blood plasma (by 29-40%).
Oxcarbazepine has been shown to interact with ethinyl estradiol and levonorgestrel. The average AUC values for them decreased by 48-52% and 35-52%, respectively. Interaction studies of oxcarbazepine with other oral or implantable contraceptives have not been conducted. Thus, the simultaneous use of oxcarbazepine and hormonal contraceptives may lead to a decrease in the effectiveness of the latter.
Co-administration of oxcarbazepine and felodipine may result in a 28% decrease in felodipine AUC, although plasma concentrations remain within the therapeutic range.
On the other hand, with simultaneous use with verapamil, a decrease in the concentration of MHD in the blood serum by 20% is possible.
This reduction has no clinical significance.
Cimetidine, erythromycin, dextropropoxyphene do not affect the pharmacokinetic parameters of MHD; viloxazine slightly affects the concentration of MHD in plasma (the concentration of MHD increases by 10% after repeated co-administration). There was no interaction with warfarin when taking both single and multiple doses of oxcarbazepine.
Oxcarbazepine may increase the sedative effect of ethanol.
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Trileptal ® . Description of the drug in the reference book Vidal.
Side effects, etc., what helps, overdose
THERE ARE CONTRAINDICATIONS. POSSIBLE SIDE EFFECTS. SPECIALIST CONSULTATION REQUIRED. Epilepsy
The author of the article
Asanova Natalia Gennadievna,
Diploma in Pharmaceutical Education: 587802
All authors
Contents of the article
- 7 Trileptal for what
- Trileptal 150
- Trileptal 600
- Trileptal: side effects
- Summary
- Ask an expert on the topic of the article
Epilepsy is the most common urological disease in the world.
According to WHO estimates, about 50 million people suffer from it. For comparison: with a diagnosis of dementia on the planet live 35 million patients.
Epilepsy is accompanied by recurrent episodes of seizures that occur due to high activity of neurons in the brain. Thanks to pharmacology in the 21st century, 70% of those suffering from epilepsy can be prevented or reduced in the frequency of seizures.
Pharmacist Natalya Asanova talks about the anticonvulsant drug Trileptal: what is included in the composition, what are the dosages and side effects.
Trileptal: mn
The active ingredient in Trileptal is oxcarbazepine. This is the “second generation” of the well-known drug carbamazepine. Due to a small change in the structure of the molecule, it has fewer side effects. The anticonvulsant effect of Trileptal is aimed at stabilizing overexcited neuronal membranes and reducing the conduction of impulses. Oxcarbazepine is included in the Federal clinical guidelines for the treatment of epilepsy and status epilepticus in adults and children.
The drug is produced by Novartis Pharma AG (Switzerland) in the form of tablets with three dosages: 150, 300 and 600 mg. The second dosage form – suspension for oral administration – is convenient for dosing and is usually used in pediatric practice. It is also suitable for patients who have difficulty swallowing tablets or in cases where it is not possible to provide a dose with tablets.
All products Trileptal
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Trileptal from what
According to the information in the RLS (Register of Medicines), Trileptal refers to antiepileptic drugs and is used as monotherapy, as well as in combination with other anticonvulsants. Trileptal is prescribed for adults and children over 1 month of age to prevent and reduce the frequency of epileptic seizures.
Indications for use:
- simple (conscious) and complex (with impairment of consciousness) partial epileptic seizures, with or without secondary generalization (loss of consciousness)
- generalized tonic-clonic seizures (change of tension and muscle spasms against the background of loss of consciousness)
Many anticonvulsants, like Trileptal, are mood stabilizers.
They have the ability to stabilize mood by reducing abnormal brain activity. They are used for mental disorders to reduce irritability, quarrelsomeness, impulsivity, dysphoria. The effectiveness of Trileptal as a potential mood stabilizer has not been proven. The official instructions do not contain indications for the use of Trileptal in bipolar disorder and depression.
Trileptal 150
Trileptal 150 mg light green oval tablets with T/D and C/G embossed on opposite sides. Due to the double-sided risk, they can be broken to make it easier to swallow. Take the tablets regardless of the meal time. Tablets of 150 mg are contraindicated in children under 3 years of age.
The initial dose for adults is 600 mg per day, divided into 2 doses. If necessary, increase the dose gradually. The dosage is prescribed by the attending physician. You need a prescription to buy Trileptal in a pharmacy.
Trileptal 600
Trileptal 600 mg light pink oval tablets with TF/TF and CG/CG embossed on opposite sides.
Also have a risk on both sides. Approved for use by children from 3 years.
Therapeutic maintenance doses are prescribed in the range of 600-2400 mg, in most patients a good clinical effect is achieved at a dose of 900 mg per day. To take the right dosage, the patient can use tablets of 150, 300 and 600 mg.
Trileptal: side effects
The drug has an inhibitory effect on the central nervous system. Therefore, in 10% of patients, Trileptal gives side effects that appear in a moderate form at the beginning of treatment and disappear over time:
- drowsiness
- headache and dizziness
- nausea, vomiting
- fatigue
- double vision (diplopia)
- attention disorder, amnesia
Often while taking Trileptal, patients gain weight, they experience nervousness, emotional instability, confusion, apathy and depression. Another drug reduces the content of sodium in the blood, especially in the elderly (need to be controlled!).