Generic Trileptal ( Oxcarbazepine )

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Trileptal is an anticonvulsant used to treat partial seizures in adults and children. It is also prescribed for bipolar disorder and certain types of nerve pain, including trigeminal neuralgia. The medication works by blocking sodium channels in the brain, which helps calm the abnormal electrical activity that causes seizures.
The usual starting dose for adults is 300 mg twice daily. Your doctor will increase the dose gradually over several weeks, usually to a target of 600 mg to 900 mg twice daily. The maximum recommended dose is 2,400 mg per day. For children, the dose is calculated based on body weight, starting at 8 to 10 mg/kg per day.
The administration form is film-coated tablets in 150 mg, 300 mg, and 600 mg strengths, plus an oral suspension of 60 mg/mL. The 150 mg tablet is light grey-green and oval, engraved with "T" and "150" on one side and "NOVARTIS" on the other. The 300 mg tablet is yellow and oval, engraved with "T" and "300" on one side and "NOVARTIS" on the other. The 600 mg tablet is pinkish-brown and oval, engraved with "T" and "600" on one side and "NOVARTIS" on the other.
Trileptal does not work overnight. Because the dose is increased slowly to improve tolerability, it may take several weeks before you notice the full benefit. Do not stop taking it just because you do not feel an effect in the first few days.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that Trileptal can cause, and it can make it harder to adjust to the medication.
The most common side effects are fatigue, headache, dizziness, and ataxia, which is a lack of muscle control or coordination.
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Common Use Trileptal

Oxcarbazepine is a keto analogue of carbamazepine. It works primarily by blocking voltage-sensitive sodium channels in the brain, which stabilizes neuronal membranes and prevents the repetitive firing that leads to seizures. Health Canada has approved Trileptal as monotherapy or adjunctive therapy for partial seizures with or without secondary generalization in adults and children aged 6 years and older. It is also used off-label for bipolar disorder, trigeminal neuralgia, and other neuropathic pain conditions. Oxcarbazepine is generally better tolerated than carbamazepine and has fewer drug interactions, which makes it a useful option when carbamazepine is ineffective or causes side effects. It is not approved for absence seizures or myoclonic seizures.

Basic Trileptal Information

• INN (International Nonproprietary Name): Oxcarbazepine
• Brand names available in Canada: Trileptal® (Novartis Pharmaceuticals Canada Inc.); generics include Apo-Oxcarbazepine (Apotex Inc.) and Jamp-Oxcarbazepine (Jamp Pharma Corporation)
• ATC Code: N03AF02
• Forms and dosages: Film-coated tablets – 150 mg, 300 mg, and 600 mg. Oral suspension – 60 mg/mL
• Manufacturers in Canada: Novartis Pharmaceuticals Canada Inc. (Trileptal), Apotex Inc. (Apo-Oxcarbazepine), Jamp Pharma Corporation (Jamp-Oxcarbazepine)
• Registration status in Canada: Approved by Health Canada. Health Canada issued a Notice of Compliance for the three tablet strengths on April 13, 2000. The 300 mg tablet (DIN 02242068) and 600 mg tablet (DIN 02242069) remain marketed. The 150 mg tablet (DIN 02242067) was cancelled post-market on October 10, 2019. The oral suspension (DIN 02244673) is marketed. Generic oxcarbazepine tablets are approved under DINs 02284308 and 02284316 (Apotex)
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Trileptal exactly as your doctor prescribes. The recommended starting dose for adults with epilepsy is 300 mg twice daily, taken with or without food. Your doctor will increase the dose gradually, usually by 300 mg to 600 mg per day at weekly intervals, until the best seizure control is achieved. The usual target range is 600 mg to 900 mg twice daily. The maximum recommended dose is 2,400 mg per day. For children, dosing is based on body weight. The starting dose is 8 to 10 mg/kg per day in two divided doses, and the maintenance dose is usually 20 to 30 mg/kg per day. For bipolar disorder, the dose is often started at 300 mg twice daily and titrated up as needed. Take the tablet with or without food. Shake the oral suspension well before measuring your dose, and use the oral dosing syringe provided. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once. Do not stop taking Trileptal suddenly without talking to your doctor. Stopping abruptly can cause seizures to return or worsen. Your doctor will taper the dose gradually over at least one to two weeks.

Precautions

Trileptal can cause low sodium levels in the blood, a condition called hyponatremia. This is more common in older adults and in people taking diuretics or certain other medications. Symptoms include headache, difficulty concentrating, memory problems, confusion, weakness, and unsteadiness. Your doctor should check your sodium levels before you start treatment and periodically during treatment, especially in the first few months. Tell your doctor if you notice any of these symptoms. Trileptal can cause serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be life-threatening. People with a certain gene type called HLA-B*1502, which is more common in people of Asian descent, have a higher risk of these reactions. If you develop a rash, blisters, peeling skin, or sores in your mouth or eyes, stop the medication and get emergency care right away. Trileptal can cause severe allergic reactions, including angioedema (swelling of the face, lips, tongue, or throat) and anaphylaxis. Stop the medication and seek emergency help if you experience difficulty breathing or swelling. The medication can cause dizziness, drowsiness, and problems with coordination, especially when you first start taking it or when your dose is increased. Until you know how it affects you, do not drive, operate heavy machinery, or do anything else that requires you to be alert. Trileptal can affect your thinking and coordination. Tell your doctor if you have liver disease, because the dose may need adjustment. Trileptal can reduce the effectiveness of hormonal contraceptives, including birth control pills. Use a backup method of contraception while taking this medication. Trileptal is not recommended during pregnancy unless the benefit clearly outweighs the risk. It can cause harm to the unborn baby. It passes into breast milk, so breastfeeding is not recommended during treatment. Women who could become pregnant should discuss the risks with their doctor. Antiepileptic drugs, including Trileptal, increase the risk of suicidal thoughts and behaviour. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately. Tell your doctor if you have a history of seizures that are different or worse after starting this medication.

Contraindications

Do not take Trileptal if you have had an allergic reaction to oxcarbazepine or any of the inactive ingredients in the tablet or suspension. Trileptal is contraindicated in patients with a known hypersensitivity to carbamazepine, because of the risk of cross-reactivity. Do not take Trileptal if you have a history of bone marrow suppression or serious blood disorders. The medication is contraindicated in patients with severe liver disease. Trileptal should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. Do not take Trileptal if you are taking monoamine oxidase inhibitors (MAOIs), because of the risk of serious interactions. The safety and effectiveness of Trileptal in children under 6 years of age have not been established. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 10% of people experience fatigue, headache, dizziness, and ataxia (lack of muscle coordination). Other common side effects include nausea, vomiting, double vision, blurred vision, nystagmus (involuntary eye movements), and tremor. Some people notice sleepiness, difficulty with concentration, and mood changes. These effects are often most noticeable when starting treatment or increasing the dose, and they may fade as your body adjusts. Serious side effects require immediate medical attention. Low sodium levels can cause headache, confusion, weakness, and seizures. Severe skin reactions can cause rash, blisters, peeling skin, and sores in the mouth or eyes. Angioedema can cause swelling of the face, lips, tongue, or throat, and difficulty breathing. Blood disorders, including leukopenia and thrombocytopenia, have been reported. Liver problems can cause jaundice, dark urine, and abdominal pain. If you develop any of these serious effects, stop the medication and seek medical help right away. Antiepileptic drugs increase the risk of suicidal thoughts or behaviour. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately.

Drug Interaction

Trileptal interacts with several medications. It is a mild inducer of CYP3A4 and an inhibitor of CYP2C19. It can reduce the effectiveness of hormonal contraceptives, including birth control pills, so use a backup method. Trileptal can increase the levels of phenytoin, requiring dose adjustment and monitoring. It can decrease the levels of carbamazepine and valproic acid. Trileptal can increase the levels of barbiturates, benzodiazepines, and tricyclic antidepressants. It may reduce the effectiveness of calcium channel blockers, including felodipine and verapamil. Diuretics, including furosemide, can increase the risk of hyponatremia when taken with Trileptal. Monoamine oxidase inhibitors (MAOIs) should not be used with Trileptal. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements. Alcohol may interact with this drug and increase drowsiness. Avoid alcohol during treatment.

Missed Dose

If you miss a dose of Trileptal, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can increase the risk of seizures, so try to take the medication at the same times each day.

Overdose

Overdose with Trileptal can cause severe drowsiness, dizziness, nausea, vomiting, fast or irregular heartbeat, and low blood pressure. In severe cases, it can cause coma, seizures, and breathing problems. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Trileptal tablets at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Store the oral suspension at room temperature and do not freeze. Shake well before each use. Use the oral dosing syringe provided to measure the dose. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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