About all

Trileptal is used for: Trileptal (Oxcarbazepine) for Bipolar Disorder

Содержание

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

View more FAQ

More about Trileptal (oxcarbazepine)

  • Check interactions
  • Compare alternatives
  • Pricing & coupons
  • Reviews (85)
  • Drug images
  • Side effects
  • Dosage information
  • During pregnancy
  • Generic availability
  • Support group
  • Drug class: dibenzazepine anticonvulsants
  • Breastfeeding
  • En español

Patient resources

  • Patient Information
  • Trileptal (Oxcarbazepine Tablets)
Other brands

Oxtellar XR

Professional resources

  • Prescribing Information

Related treatment guides

  • Epilepsy
  • Seizures

Further information

  • Your pharmacist has information about Trileptal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Trileptal only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 10.09.

Trileptal and Tivicay compatibility: features and recommendations

Content

  • 1 Trileptal and Tivicay compatibility
    • 1.1 Effects of Trileptal and Tivicay on the body
    • 1.2 Related videos:
    • 900 05 1.3 Features of the effect of the drug Trileptal

    • 1.4 Features of the effect of the drug Tivicay
    • 1.5 Possible side effects from the simultaneous use of Trileptal and Tivicay
    • 1.6 Influence on the digestive system
    • 1.7 Effects on the nervous system
    • 1.8 How to take Trileptal and Tivicay
      • 1. 8.1 Trileptal
      • 1.8.2 Tivicay
    • 1.9 Dosage recommendations
    • 1.10 Q&A:
        • 1.10.0.1 Can Trileptal and Tivicay be taken at the same time?
        • 1.10.0.2 What side effects can occur when taking Trileptal and Tivicay at the same time?
        • 1.10.0.3 Can Trileptal and Tivicay interact with each other?
        • 1.10.0.4 Can I change the dosage of Trileptal and Tivicay by myself?
        • 1.10.0.5 What are the recommendations for taking Trileptal and Tivicay?
        • 1.10.0.6 Can Trileptal and Tivicay cause an allergic reaction?

Trileptal and Tivicay drug compatibility is important information for patients taking these drugs. Find out what interactions may occur with simultaneous use, how to avoid possible side effects and what you should discuss with your doctor before starting a combined drug regimen.

When treating neurological conditions such as epilepsy and trigeminal neuralgia, doctors often prescribe a combination of drugs to achieve the best effect and control symptoms. One such combination is Trileptal and Tivicay.

Trileptal (also known as oxcarbazepine) is an anticonvulsant used to control epileptic seizures. It works by decreasing the excitability of nerve cells and lowering the activity of certain chemicals in the brain that cause seizure activity. Tivicay (gabapentin) is an antiepileptic drug that is also used to treat trigeminal neuralgia and other neuropathic pain. It works by decreasing the excitability of nerve cells and reducing the transmission of pain signals in the brain.

Together, these drugs may enhance each other’s effects and provide better symptom control. However, before starting the combined use of Trileptal and Tivicay, it is necessary to consult a doctor and undergo appropriate medical examinations. The doctor will determine the optimal dosage and regimen of taking drugs in accordance with the individual characteristics of the patient and the nature of his disease.

It is important to remember that the combination of Trileptal and Tivicay may cause unwanted side effects such as drowsiness, dizziness, muscle weakness and incoordination. If any side effects occur, you should immediately consult a doctor.

In conclusion, the combination of Trileptal and Tivicay may be effective in controlling neurological conditions such as epilepsy and trigeminal neuralgia. However, before you start taking these drugs, you should consult your doctor and follow the recommendations for dosage and regimen. Only a doctor can determine the optimal combination of drugs and monitor the patient’s condition throughout the treatment.

Effects of Trileptal and Tivicay on the body

Trileptal and Tivicay are drugs used to treat a variety of neurological conditions, including epilepsy. Both drugs have an effect on the body, but have some differences in their mechanism of action and side effects.

Trileptal contains the active substance oxcarbazepine, which is an antiepileptic drug. It acts on nerve impulses in the brain, reducing the excitability of nerve cells and preventing the occurrence of seizures. Trileptal may also be used to treat other conditions such as facial neuralgia and bipolar disorder.

Tivicay contains the active substance topiramate, which is also an antiepileptic drug. It acts on nerve impulses, reducing the excitability of nerve cells and preventing seizures. Tivicay can also be used to treat migraines and prevent secondary epilepsy attacks.

Both drugs may cause some side effects. Some common side effects associated with the use of Trileptal and Tivicay include headache, dizziness, drowsiness, nausea, and changes in taste. However, each drug has its own specific side effects that some patients may experience.

When using Trileptal and Tivicay, it is important to follow your doctor’s instructions and take your medication exactly as directed. It is necessary to inform the doctor about all side effects that may occur while taking the drugs. You should also avoid alcohol and other drugs that can interact with Trileptal and Tivicay.

In general, Trileptal and Tivicay are effective drugs for the treatment of neurological diseases, but require careful monitoring and appropriate medical prescription.

Related videos:

Features of the effect of the drug Trileptal

Trileptal (oxcarbazepine) is an antiepileptic drug that is widely used to treat various forms of epilepsy. It has a number of impact features that must be considered when using it.

  • Anticonvulsant action: Trileptal has an anticonvulsant effect by blocking sodium channels in neurons and thereby reducing the excitability of the nervous system. This allows you to control and prevent epileptic seizures.
  • Multiprotective action: In addition to its anticonvulsant action, Trileptal has a multiprotective effect, which consists in protecting neurons from damage and reducing inflammation in the brain. This property of the drug can be useful in the treatment of not only epilepsy, but also other neurological diseases.
  • Pharmacokinetics: Trileptal has good absorption from the gastrointestinal tract and a fast onset of action. It is metabolized in the liver and excreted in the urine. The dosage of the drug should be individually selected depending on the patient’s performance and comorbidities.

It is important to note that Trileptal may cause some side effects such as drowsiness, dizziness, nausea and vomiting. Therefore, before starting treatment, it is necessary to consult a doctor and strictly follow the recommendations for dosage and administration of the drug.

Effects of Tivicay

Tivicay is an antiepileptic drug, the main active ingredient of which is topiramate. This drug has a number of features that should be considered when using it.

  1. Mechanism of action. Tivicay has an antiepileptic effect through its effect on ion channels and neurotransmitters in the central nervous system. It enhances the action of gamma-aminobutyric acid (GABA), which is the main inhibitory neurotransmitter in the brain. Also, the drug reduces the activity of glutamate, which is the main excitatory neurotransmitter.
  2. Use. Tivicay is used as an additional drug in the treatment of epilepsy in children and adults. It is effective in both partial and generalized seizures of epilepsy. Also, the drug can be used in the treatment of migraine.
  3. Side effects. When using Tivicay, various side effects may occur. The most commonly observed are drowsiness, dizziness, impaired concentration, loss of appetite, nausea, diarrhea, changes in taste sensations. Also, some patients may experience increased sensitivity to sunlight and the risk of developing kidney stones.
  4. Interaction with other drugs. Tivicay can interact with other medicines, so you should consult your doctor before taking it. It is especially important to consider possible interactions with other antiepileptic drugs, antidepressants and anticancer drugs.

It is important to note that Tivicay should only be prescribed and used under medical supervision. Self-medication can lead to undesirable consequences and deterioration of the patient’s condition. If you experience any side effects, you should consult a doctor to correct the treatment.

Potential side effects from concomitant use of Trileptal and Tivicay

Simultaneous use of Trileptal (oxcarbazepine) and Tivicay (topiramate) can cause some side effects that are important to consider when prescribing combination therapy.

The following are some of the possible side effects that may occur when these drugs are used simultaneously:

  • Drowsiness and dizziness: both drugs can cause drowsiness and dizziness. With their simultaneous use, these side effects can be enhanced, which can adversely affect the patient’s performance and safety.
  • Problems with memory and concentration: some patients taking Trileptal and Tivicay at the same time may experience problems with memory and concentration. This can make it difficult to complete daily tasks and study.
  • Irritability: In some patients, the combination of Trileptal and Tivicay may cause increased irritability and nervousness.
  • Increased sensitivity to sunlight: Some patients may become more sensitive to sunlight while taking Trileptal and Tivicay. It is recommended to use sunscreen and limit sun exposure.

It is important to note that not all patients taking the combination of Trileptal and Tivicay will experience these side effects. However, if you experience any unwanted symptoms while taking these drugs, you should contact your doctor for advice and possible treatment adjustments.

Before starting combination therapy with Trileptal and Tivicay, it is recommended to consult a doctor who can evaluate the indications for use and prescribe the optimal dosage to achieve maximum therapeutic effect with minimal risk of side effects.

Effects on the digestive system

Trileptal and Tivicay may affect the digestive system. Possible side effects related to the digestive system include:

  • Diarrhea. Diarrhea may occur in some patients taking Trileptal and Tivicay. This may be due to changes in bowel function or increased activity in the gastrointestinal tract. If the diarrhea becomes too intense or prolonged, you should consult a doctor.
  • Nausea and vomiting. Some patients may experience nausea or vomiting while taking Trileptal and Tivicay. This can be caused by irritation of the stomach lining or changes in the digestive system.
  • Increased appetite. Some patients may experience an increase in appetite while taking Trileptal and Tivicay. This can lead to weight gain and weight management problems. Patients are advised to monitor their diet and lead an active lifestyle.

If a patient has problems with the digestive system while taking Trileptal and Tivicay, it is necessary to consult a doctor for advice and possible dosage adjustment or drug replacement.

Effects on the nervous system

Trileptal and Tivicay have effects on the human nervous system. These drugs are used to treat various neurological conditions such as epilepsy.

Trileptal contains the active ingredient oxcarbazepine, which is an anticonvulsant. It has a stabilizing effect on nerve impulses and helps prevent the occurrence of epileptic seizures. Trileptal may also be used to treat bipolar affective disorder.

Tivicai contains the active ingredient tiagabine. This drug is used to treat partial seizures of epilepsy in adults. Tivicay works by increasing the concentration of gamma-aminobutyric acid (GABA) in the brain, which helps to reduce the excitability of nerve cells.

Both drugs may cause some nervous system side effects. Some of these may include dizziness, drowsiness, incoordination, and mood changes. However, these side effects may be temporary and disappear over time.

It is important to consult your doctor before starting treatment with these drugs in order to assess their compatibility and avoid possible unwanted effects on the nervous system. The doctor can evaluate the benefits of using drugs and decide which one is most appropriate for a particular situation.

How to take Trileptal and Tivicay

Take Trileptal and Tivicay exactly as prescribed by your doctor and in accordance with the instructions that come with each medication. Below are the main recommendations for taking these drugs:

Trileptal

  • It is recommended to take Trileptal orally after meals with plenty of water.
  • The dosage of the drug is determined individually by the doctor, depending on the severity and nature of the disease.
  • The usual starting dose for adults is 300-600 mg per day, divided into 2-3 doses. In the future, the dose may be adjusted.
  • Not recommended for use in children under 6 years of age.
  • The duration of treatment with Trileptal is determined by the doctor, depending on the effectiveness and tolerability of the drug.

Tivicay

  • It is recommended to take Tivicay orally after meals with plenty of water.
  • The dosage of the drug is determined individually by the doctor, depending on the severity and nature of the disease.
  • The usual starting dose for adults is 50-100 mg per day divided into 2-3 doses. In the future, the dose may be adjusted.
  • Not recommended for use in children under 12 years of age.
  • The duration of treatment with Tivicay is determined by the physician, depending on the efficacy and tolerability of the drug.

It is important to remember that self-medication and changing the dosage of drugs without consulting a doctor can be hazardous to health. If you have any questions or doubts, you should contact your doctor or pharmacist for advice.

Dosage recommendations

Dosage of Trileptal and Tivicay should be prescribed by a physician and should be tailored to the individual patient. It is important to strictly follow the recommendations for dosage indicated in the instructions for the drug and received from the doctor.

The dosage of Trileptal depends on the age and weight of the patient, as well as the severity and nature of the disease. Usually the initial dose for adults is 600-1200 mg per day, divided into 2-3 doses. For children, the dosage is determined by the doctor depending on age and weight, usually the initial dose is 8-10 mg / kg of body weight per day, divided into several doses.

The dosage of Tivicay also depends on the age and weight of the patient, as well as the severity and nature of the disease. For adults, it is recommended to start with a dose of 25-50 mg per day, gradually increasing to an effective dose, which is usually 200-400 mg per day. For children, the dosage is determined by the doctor depending on age and weight, usually the initial dose is 1-2 mg / kg of body weight per day, divided into several doses.

It is important to remember that the dosage of drugs can be changed by the doctor depending on the effectiveness of the treatment and the appearance of side effects. It is not recommended to independently change the dosage or stop taking the drugs without consulting a doctor.

To achieve the optimal effect of the treatment, it is recommended to take the drugs regularly at the same time every day. If you miss a dose, take the missed dose as soon as possible, but do not take two doses at the same time.

If you have any questions or doubts about the dosage of drugs, you should consult a doctor for advice and individual recommendations.

Q&A:

Can I take Trileptal and Tivicay at the same time?

Yes, Trileptal and Tivicay can be taken at the same time, but only after consultation with your doctor. It is important to take into account the individual characteristics of the patient and possible side effects.

What side effects can occur when taking Trileptal and Tivicay at the same time?

When taking Trileptal and Tivicay at the same time, side effects such as dizziness, drowsiness, nausea, vomiting, allergic reactions and others may occur. It is important to consult your doctor and follow his recommendations.

Can Trileptal and Tivicay interact with each other?

Yes, Trileptal and Tivicay can interact with each other. Perhaps the strengthening or weakening of the action of one of the drugs. Therefore, before taking it at the same time, it is necessary to consult a doctor.

Can I change the dosage of Trileptal and Tivicay on my own?

No, you cannot change the dosage of Trileptal and Tivicay on your own. The dosage should be determined by the doctor and adjusted only on his recommendation.

What are the recommendations for taking Trileptal and Tivicay?

Recommendations for the use of Trileptal and Tivicay must be given by the physician individually for each patient. Usually drugs are taken at a certain time, before or after meals, taking into account other medications and the individual characteristics of the patient.

Can Trileptal and Tivicay cause an allergic reaction?

Yes, Trileptal and Tivicay may cause an allergic reaction in some patients. If a rash, itching, swelling of the lips or face appear, you should immediately consult a doctor and stop taking the medication.

Trileptal instructions for use: indications, contraindications, side effects – description of Trileptal tab. film coated, 600 mg: 10, 20, 30 or 50 pcs. (37336)

💊 Composition of Trileptal ®

✅ Use of Trileptal ®

Save

Search for analogues

Interaction

Description of the active ingredients of the preparation

Trileptal ®
(Trileptal ® )

The scientific information provided is general and cannot be used to make decisions.
decisions about the use of a particular drug.

Update date: 2020.05.07

Marketing authorization holder:

NOVARTIS PHARMA, AG
(Switzerland)

Made:

NOVARTIS PHARMA STEIN, AG

(Switzerland)

ATX code:

N03AF02

(Oxcarbazepine)

Active substance:
oxcarbazepine
(oxcarbazepine)

Rec.INN

WHO registered

Dosage form

Trileptal ®

Tab. , coated film coated, 600 mg: 10, 20, 30 or 50 pcs.

reg. No.: P N015199/01
dated 18.06.09
– Indefinitely

Release form, packaging and composition
Trileptal

®

Film-coated tablets are yellow, oval, slightly biconvex, scored on both sides, marked “TF/TF” on one side and “CG/CG” on the other.

Excipients : colloidal silicon dioxide, microcrystalline cellulose, hypromellose, crospovidone, magnesium stearate, macrogol 8000, talc, titanium dioxide (E171), purified water, iron oxide yellow (E172).

10 pcs. – blisters (1) – packs of cardboard.
10 pcs. – blisters (2) – packs of cardboard.
10 pcs. – blisters (3) – packs of cardboard.
10 pcs. – blisters (5) – packs of cardboard.

Clinical and pharmacological group:

Anticonvulsant drug

Pharmacotherapeutic group:

Anticonvulsant

Pharmacological action

Antiepileptic. 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.

The implementation of the anticonvulsant action is facilitated by an increase in the conductivity of potassium ions and the modulation of calcium channels activated by a high membrane potential. There was no significant interaction with brain neurotransmitters or receptor binding. Experimental studies have shown that oxcarbazepine and its metabolite have a pronounced anticonvulsant effect.

The efficacy of oxcarbazepine in epileptic seizures has been demonstrated both in monotherapy and in the use of oxcarbazepine as part of combination therapy in children and adults.

Pharmacokinetics

After oral administration, oxcarbazepine is completely absorbed and largely metabolized to form the pharmacologically active metabolite, the 10-monohydroxy derivative. 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.

Binding of the metabolite to plasma proteins, mainly albumin, is about 40%. In the therapeutic range, the degree of binding does not depend on the concentration of the drug in the blood serum. Oxcarbazepine and MGP do not bind to α 1 -acid glycoprotein. Apparent V d – 49 l. With ss MHD in blood plasma is achieved on the 2nd-3rd day when taking oxcarbazepine 2 times / day. In the equilibrium state, the pharmacokinetic parameters of MGP are linear and dose-dependent in the range of daily doses of 300 mg – 2400 mg.

Oxcarbazepine is rapidly metabolized by hepatic cytosolic enzymes to the pharmacologically active metabolite MHD, which undergoes further glucuronidation. Minor amounts of MHP (about 4% of the dose) are oxidized to form an inactive metabolite – 10, 11-dihydroxy derivative (DHP).

Oxcarbazepine is excreted as metabolites mainly by the kidneys (95%), less than 1% is excreted unchanged. Approximately 80% of excreted metabolites are MHD, of which 49% are glucuronides and 27% are unchanged MGP. DGP is excreted unchanged (about 3%), oxcarbazepine conjugates account for 13%. About 4% of the dose is excreted in the feces.

Oxcarbazepine is rapidly excreted from the blood plasma, the apparent T 1/2 is 1.3 – 2.3 hours. GP from creatinine clearance. With CC less than 30 ml / min after a single dose of 300 mg of oxcarbazepine T 1/2 MHL increases to 19 hours, and AUC doubles.

Weight-adjusted MHD clearance in children decreases with age and body weight, approaching that of adults. Weight-adjusted clearance in children aged 1 month to 4 years is 93% higher than in adults. As a result, it is expected that the AUC of MHD in children of this age group will be 2 times less than that in adults when using the same doses (when adjusted for body weight). 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.

After taking oxcarbazepine at a single dose of 300 mg or multiple doses of 600 mg/day in healthy volunteers aged 60-82 years, plasma C max and AUC values ​​for MHD were 30-60% higher compared with the same indicators in young volunteers (18-32 years), which is associated with an age-related decrease in K K.

Pregnant women experience a number of physiological changes that can lead to a gradual decrease in plasma levels of MHD during pregnancy.

Indications of the active substances of the drug

Trileptal

®

Simple and 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.

Open list of ICD-10 codes

G40 Epilepsy

Dosage 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 side of 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 when using oxcarbazepine in toxic doses, there was an increase in embryonic mortality, slowing down and impaired development and growth of the fetus. 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 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.

With the development of symptoms of severe bone marrow suppression, consider discontinuing oxcarbazepine.

Patients treated with 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, discontinuation 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 MGP against isoenzymes of the CYP2B and CYP3A4 enzyme subsystems. The inducing effect of oxcarbazepine and MHD on other CYP isoenzymes is unknown.

Plasma concentrations of phenytoin increase 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 plasma concentrations of MHD (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.

Leave a Reply

Your email address will not be published. Required fields are marked *