Trileptal

Oxcarbazepine comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken every 12 hours (twice a day) with or without food. Take oxcarbazepine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxcarbazepine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the suspension well right before each use to mix the medication evenly. Use the oral dosing syringe that came with the medication to withdraw the right amount of suspension from the bottle. You can swallow the suspension straight from the syringe or you can mix it with a small glass of water and swallow the mixture. Wash the syringe with warm water and allow it to dry thoroughly after use.

Your doctor will probably start you on a low dose of oxcarbazepine and gradually increase your dose, not more often than once every 3 days. If you were taking another medication to treat your seizures and are switching to oxcarbazepine, your doctor may gradually decrease your dose of the other medication while increasing your dose of oxcarbazepine. Follow these directions carefully and ask your doctor if you are not sure how much medication you should take.

Oxcarbazepine may help control your seizures but will not cure your condition. Continue to take oxcarbazepine even if you feel well. Do not stop taking oxcarbazepine without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking oxcarbazepine, your seizures may get worse. Your doctor will probably decrease your dose gradually.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with oxcarbazepine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Unless your doctor tells you otherwise, continue your normal diet.

Trileptal is a prescription medication used to treat partial seizures in adults and children 2 years and older with epilepsy. It may be used alone or with other medications. Trileptal belongs to a group of drugs called anticonvulsants, which work by decreasing abnormal electrical activity in the brain.

This medication comes in a tablet and in an oral suspension form. Trileptal is usually taken twice daily, with or without food.

Common side effects of Trileptal include dizziness, sleepiness, double vision, and nausea. Do not drive or operate heavy machinery until you know how Trileptal affects you.

See “Drug Precautions”.

Trileptal may cause other serious side effects including:

• your seizures can happen more often or become worse 
• trouble concentrating 
• problems with your speech and language 
• feeling confused 
• feeling sleepy and tired
• trouble walking and with coordination

Get medical help right away if you have any of the symptoms listed above or listed in “Drug Precautions”.

The most common side effects of Trileptal include:

• dizziness 
• sleepiness 
• double vision 
• tiredness 
• nausea 
• vomiting 
• problems with vision 
• stomach pain 
• trembling 
• upset stomach 
• problems with walking and coordination (unsteadiness) 
• rash
• infections (especially in children)

These are not all the possible side effects of Trileptal. For more information, ask your healthcare provider or pharmacist.

Before taking Trileptal, tell your healthcare provider about all your medical conditions, including if you:

• have or have had suicidal thoughts or actions, depression or mood problems
• have liver problems
• have kidney problems
• are allergic to carbamazepine. Many people who are allergic to carbamazepine are also allergic to Trileptal. 
• use birth control medicine. Trileptal may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use. 
• are pregnant or plan to become pregnant. 

• are breastfeeding or plan to breastfeed. 

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Trileptal passes into breast milk. You and your healthcare provider should discuss whether you should take Trileptal or breastfeed; you should not do both.

May inhibit CYP2C191 2 4 and induce CYP3A4 and CYP3A5.1 4 Weakly induces UDP-glucuronyl transferase.1

Drugs Metabolized by Hepatic Microsomal Enzymes

CYP2C19 substrates: Potential pharmacokinetic interaction (increased plasma concentrations of CYP2C19 substrate).1

CYP3A4 and CYP3A5 substrates: Potential pharmacokinetic interaction (decreased plasma concentrations of CYP3A4 or CYP3A5 substrate).1

Specific Drugs

Storage

Oral

Tight container at 25°C (may be exposed to 15–30°C).1

Original container at 25°C (may be exposed to 15–30°C).1 Use within 7 weeks of opening container.1

• Risk of hypersensitivity reaction; patients who have had previous hypersensitivity reaction to carbamazepine at increased risk.1 4 Importance of immediately reporting hypersensitivity reactions, skin reactions, or fever accompanied by signs and/or symptoms of other organ system involvement (e.g., rash, lymphadenopathy).1

• Risk of dizziness and somnolence; avoid driving or operating machinery until effects on individual are known.1 20 21

• Risk of suicidality (anticonvulsants may increase risk of suicidal thoughts or actions in about 1 in 500 people).18 22 23 Importance of patients, family members, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one's life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).18 23

• Risk of low sodium concentrations in the blood; manifestations may include nausea, extreme drowsiness and/or fatigue, discomfort, headache, confusion, increase in seizure frequency or severity, or dullness.1 20 21

• Caution if alcohol is used concomitantly, because additive sedative effects may occur.1

• Importance of not abruptly discontinuing therapy.1

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 Importance of informing women of childbearing age that concomitant use of oxcarbazepine with oral contraceptives may result in decreased efficacy of the contraceptives.1 4

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of advising patients of other important precautionary information.1 (See Cautions.)

Trileptal is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Trileptal is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is:

Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27.

Trileptal film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Trileptal oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma.

Do not drink alcohol. Drinking alcohol can increase certain side effects of oxcarbazepine. Alcohol may also increase the risk of seizures.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Trileptal may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not drink alcohol. Drinking alcohol can increase certain side effects of oxcarbazepine. Alcohol may also increase the risk of seizures.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Oxcarbazepine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.