Trileptal

DRUG DESCRIPTION

Trileptal (oxcarbazepine) is an antiepileptic drug available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Trileptal (oxcarbazepine) is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,1 l-Dihydro-10-oxo-5H-dibenz[b,f|azepine-5-carboxamide, and its structural formula is

Trileptal®
  (oxcarbazepine) Structural Formula Illustration

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 (oxcarbazepine) 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 (oxcarbazepine) 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.

What are the possible side effects of oxcarbazepine (Trileptal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have nausea, vomiting, weakness, thirst, loss of appetite, headache, confusion, hallucinations, muscle pain or weakness, and/or increased or more severe seizures.

Call your doctor at once if you have any...

Read All Potential Side Effects and See Pictures of Trileptal »

What are the precautions when taking oxcarbazepine (Trileptal)?

Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell your doctor your medical history, including: kidney disease, decreased sodium blood levels (hyponatremia), recent seizures.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition...

Read All Potential Precautions of Trileptal »


Trileptal Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, fatigue, nausea, vomiting, headache, trouble sleeping, acne, dry mouth, or constipation may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if you develop any of these serious side effects: double vision, change in vision, involuntary eye movements, difficulty speaking, difficulty concentrating, loss of coordination, trouble walking (abnormal gait), uncontrolled muscle movements (tremor), dulled sense of touch.

Tell your doctor immediately if you develop any of these unlikely but very serious side effects: easy bleeding/bruising, chest pain, persistent sore throat, stomach/abdominal pain, bloody stool, dark urine, change in amount of urine, yellowing of eyes/skin.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: fever, rash, itching/swelling (especially of the face/tongue/throat/lymph nodes), joint/muscle pain, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell your doctor your medical history, including: kidney disease, decreased sodium blood levels (hyponatremia), recent seizures.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Trileptal Patient Information Including Side Effects

Brand Names: Trileptal

Generic Name: oxcarbazepine (Pronunciation: ox kar BAY zeh peen)

  • What is oxcarbazepine (Trileptal)?
  • What are the possible side effects of oxcarbazepine (Trileptal)?
  • What is the most important information I should know about oxcarbazepine (Trileptal)?
  • What should I discuss with my healthcare provider before taking oxcarbazepine (Trileptal)?
  • How should I take oxcarbazepine (Trileptal)?
  • What happens if I miss a dose (Trileptal)?
  • What happens if I overdose (Trileptal)?
  • What should I avoid while taking oxcarbazepine (Trileptal)?
  • What other drugs will affect oxcarbazepine (Trileptal)?
  • Where can I get more information?

What is oxcarbazepine (Trileptal)?

Oxcarbazepine is in a group of drugs called anticonvulsants, or antiepileptic drugs. It works by decreasing nerve impulses that cause seizures.

Oxcarbazepine is used to treat partial seizures in adults and children who are at least 2 years old.

Oxcarbazepine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of oxcarbazepine (Trileptal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have nausea, vomiting, weakness, thirst, loss of appetite, headache, confusion, hallucinations, muscle pain or weakness, and/or increased or more severe seizures.

Call your doctor at once if you have any new or worsening symptoms 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.

Call your doctor at once if you have any of these serious side effects:

  • sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • jaundice (yellowing of the skin or eyes);
  • fever, swollen glands, flu-like symptoms;
  • easy bruising or bleeding, unusual weakness;
  • urinating less than usual or not at all; or
  • increased seizures.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain, diarrhea;
  • problems with speech, balance, or coordination;
  • blurred vision;
  • mental slowness, trouble concentrating;
  • tremors or shaking;
  • dizziness, drowsiness; or
  • skin 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 is the most important information I should know about oxcarbazepine (Trileptal)?

Do not take this medication if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol).

Before taking oxcarbazepine, tell your doctor if you have liver or kidney disease.

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Oxcarbazepine should not be used during pregnancy, but taking the medicine can make birth control pills less effective. Use a non-hormone method of birth control (not birth control pills) to prevent pregnancy while you are taking oxcarbazepine. Tell your doctor if you become pregnant during treatment.

Oxcarbazepine can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Contact your doctor right away if you have nausea with vomiting, weakness, headache, confusion, mood changes, and/or increased or more severe seizures.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms 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.

There are many other medicines that can interact with oxcarbazepine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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