TRILEPTAL 300 mg
100 (oxcarbazepine) Film-Coated Tablets
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 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 headache, trouble concentrating, memory problems, weakness, loss of appetite, feeling unsteady, confusion, hallucinations, fainting, shallow breathing, and/or increased or more severe 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.
Call your doctor at once if you have a serious side effect such as:
- increased seizures;
- swollen glands, fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- severe tingling, numbness, pain, muscle weakness;
- urinating less than usual or not at all;
- chest pain, dry cough, wheezing, feeling short of breath;
- upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- headache, mental slowness, trouble concentrating;
- problems with speech, balance, or walking;
- dizziness, drowsiness, tired feeling;
- mild nausea, vomiting, upset stomach, diarrhea;
- blurred vision, double vision;
- tremors or shaking; 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.
Read the Trileptal (oxcarbazepine) Side Effects Center for a complete guide to possible side effects
rileptal (oxcarbazepine) is an anticonvulsant, or antiepileptic drug, used to treat partial seizures in adults and children who are at least 2 years old. Trileptal is available in generic form. Common side effects of Trileptal include:
- dizziness,
- drowsiness,
- tired feeling,
- fatigue,
- nausea,
- vomiting,
- upset stomach,
- diarrhea,
- headache,
- mental slowness,
- trouble concentrating,
- trouble sleeping,
- shaking,
- acne,
- skin rash,
- blurred or double vision,
- dry mouth,
- constipation, and
- problems with speech, balance, or walking.
- changes in vision,
- involuntary eye movements,
- difficulty speaking,
- difficulty concentrating,
- loss of coordination,
- trouble walking (abnormal gait),
- uncontrolled muscle movements (tremor),
- dulled sense of touch,
- easy bleeding or bruising,
- chest pain,
- persistent sore throat,
- stomach or abdominal pain,
- bloody stool,
- dark urine,
- change in amount of urine, or
- yellowing of eyes or skin.
Treatment with Trileptal starts at a dose of 600 mg/day, twice daily. If needed, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Trileptal may interact with carbamazepine, phenobarbital, phenytoin, or valproic acid. Many other medicines may interact with oxcarbazepine. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Trileptal should be used only when prescribed. It may harm a fetus. Since untreated seizures are a serious condition that can harm both a pregnant woman and the fetus, do not stop taking this medication unless directed by your doctor. Hormonal birth control may not work if taken with this medication. Discuss birth control with your doctor. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Trileptal (oxcarbazepine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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)?
You should not take this medication if you are allergic to oxcarbazepine.
Before you take oxcarbazepine, tell your doctor if you have liver or kidney disease.
Oxcarbazepine can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking oxcarbazepine.
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 headache, problems with thinking or memory, weakness, loss of appetite, feeling unsteady, confusion, hallucinations, fainting, shallow breathing, and/or increased or more severe seizures.
You may have thoughts about suicide when you first start taking this medicine. Your doctor will need to check you at regular visits.
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 medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
What should I discuss with my healthcare provider before taking oxcarbazepine (Trileptal)?
You should not take this medication if you are allergic to oxcarbazepine.
To make sure you can safely take oxcarbazepine, tell your doctor if you have any of these other conditions:
- liver disease;
- kidney disease; or
- if you are allergic to a similar medicine called carbamazepine (Carbatrol, Tegretol).
You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
FDA pregnancy category C. It is not known whether oxcarbazepine will harm an unborn baby. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Follow your doctor's instructions about taking oxcarbazepine while you are pregnant.
Oxcarbazepine can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking oxcarbazepine.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of oxcarbazepine on the baby.
Oxcarbazepine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking oxcarbazepine.
Do not give this medication to a child younger than 2 years old.
How should I take oxcarbazepine (Trileptal)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Oxcarbazepine should be taken twice daily.
Take oxcarbazepine with a full glass of water.
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, use the oral dosing syringe provided with this medicine. If you did not receive an oral syringe with your medication, ask your pharmacist for one.
Give the oral 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.
Use oxcarbazepine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Do not stop using oxcarbazepine without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using oxcarbazepine suddenly. You may need to use less and less before you stop the medication completely.
While using oxcarbazepine, you may need blood tests at your doctor's office. Visit your doctor regularly.
Wear a medical alert tag or carry an ID card stating that you take oxcarbazepine. Any medical care provider who treats you should know that you are using oxcarbazepine.
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 (Trileptal)?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose (Trileptal)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking oxcarbazepine (Trileptal)?
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.
Drinking alcohol can increase certain side effects of oxcarbazepine. Alcohol may also increase the risk of seizures.
What other drugs will affect oxcarbazepine (Trileptal)?
Tell your doctor about all other medicines you use, especially:
- carbamazepine (Carbatrol, Tegretol);
- cyclosporine (Gengraf, Neoral, Sandimmune);
- felodipine (Plendil);
- phenobarbital (Luminal, Solfoton);
- phenytoin (Dilantin);
- valproic acid (Depakene); or
- verapamil (Calan, Covera, Isoptin, Verelan).
This list is not complete and there are many other drugs that can interact with oxcarbazepine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
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