Trioptal (Oxcarbazepine) 300 mg

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Trioptal (Oxcarbazepine) 300 mg

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What is Trileptal (Oxcarbazepine)?
Trileptal (Oxcarbazepine) is in a group of drugs called anticonvulsants, or antiepileptic drugs. It works by decreasing nerve impulses that cause seizures.Trileptal (Oxcarbazepine) is used to treat partial seizures in adults and children with epilepsy who are at least 2 years old. It may be used alone or in combination with other medicines.Trileptal (Oxcarbazepine) may also be used for other purposes not listed in this medication guide.
 


 Important information about Trileptal (Oxcarbazepine)


Do not take Trileptal (Oxcarbazepine) if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol).Before taking Trileptal (Oxcarbazepine), tell your doctor if you have liver or kidney disease.Do not use Trileptal (Oxcarbazepine) without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. This medication 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 Trileptal (Oxcarbazepine). Tell your doctor if you become pregnant during treatment.Trileptal (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 Trileptal (Oxcarbazepine). 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 Trileptal (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.


Before taking Trileptal (Oxcarbazepine)
Do not take Trileptal (Oxcarbazepine) if you are allergic to oxcarbazepine or to a similar medicine called carbamazepine (Carbatrol, Tegretol).Before taking Trileptal (Oxcarbazepine), tell your doctor if you have liver or kidney disease. If you have any of these conditions you may not be able to use this medication, or you may require a dose adjustment or special tests during treatment.You may have thoughts about suicide while taking Trileptal (Oxcarbazepine). 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 D. Trileptal (Oxcarbazepine) can cause harm to an unborn baby. Trileptal (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 Trileptal (Oxcarbazepine). Tell your doctor if you become pregnant during treatment. Oxcarbazepine can pass into breast milk and may harm a nursing baby. Do not use Trileptal (Oxcarbazepine) without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 2 years old.


How should I take Trileptal (Oxcarbazepine)?
Take Trileptal (Oxcarbazepine) exactly as it was prescribed for you. Do not take this medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.Take Trileptal (Oxcarbazepine) with a full glass of water. Shake the Trileptal (Oxcarbazepine) 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 Trileptal (Oxcarbazepine) 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.Do not stop taking this medication even if you feel better. It is important to take Trileptal (Oxcarbazepine) regularly to prevent seizures from recurring. Get your prescription refilled before you run out of medicine completely. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures. Carry an ID card or wear a medical alert bracelet stating that you are taking Trileptal (Oxcarbazepine), in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a seizure disorder.Seizures are often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.


Store Trileptal (Oxcarbazepine) at room temperature away from moisture and heat.


What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.Symptoms of an Trileptal (Oxcarbazepine) overdose are unknown.


What should I avoid while taking Trileptal (Oxcarbazepine)?
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 (Oxcarbazepine) can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not drink alcohol while taking Trileptal (Oxcarbazepine). Alcohol may increase drowsiness caused by Trileptal (Oxcarbazepine). It may also increase the risk of seizures.


Side Effects of Trileptal (Oxcarbazepine):
Trileptal (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.Get emergency medical help if you have any of these signs of an allergic reaction to Trileptal (Oxcarbazepine): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.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; orincreased seizures.
Less serious Trileptal (Oxcarbazepine) 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; orskin rash.This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. 


What other drugs will affect Trileptal (Oxcarbazepine)?
Before using Trileptal (Oxcarbazepine), tell your doctor about all other seizure medications you are taking, including:carbamazepine (Carbatrol, Tegretol);phenobarbital (Luminal, Solfoton);phenytoin (Dilantin); orvalproic acid (Depakene).



Generic Name Oxcarbazepine
Search Name Trileptal Brand 300 mg Tab
Supply Name Trioptal
Brand Generic BRAND NAME
Presentation Foil in Box
Dosage Tab
USA Brand Trileptal
Manufacture Novartis India
Strength 300 mg
Search Terms Trileptal ,Trioptal ,Oxcarbazepine
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to oxcarbazepine: oral suspension, oral tablet, oral tablet extended release

Along with its needed effects, oxcarbazepine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking oxcarbazepine:

More common
- Change in vision
- change in walking or balance
- clumsiness or unsteadiness
- cough, fever, sneezing, or sore throat
- crying
- dizziness
- double vision
- false sense of well-being
- feeling of constant movement of self or surroundings
- mental depression
- sensation of spinning
- uncontrolled back-and-forth and/or rolling eye movements

Less common
- Agitation
- awkwardness
- bloody or cloudy urine
- blurred vision
- bruising
- confusion
- convulsions (seizures)
- decreased urination
- difficulty with focusing eyes
- disorientation
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- fast or irregular heartbeat
- frequent falls
- frequent urge to urinate
- headache
- hoarseness
- increased thirst
- itching of the vagina
- loss of consciousness
- memory loss
- muscle cramps
- pain or burning while urinating
- pain or tenderness around the eyes or cheekbones
- problems with coordination
- shaking or trembling of the arms, legs, hands, and feet
- skin rash
- stuffy or runny nose
- tightness in the chest
- trouble with walking
- troubled breathing
- unusual feelings
- unusual tiredness or weakness

Rare
- Anxiety
- bleeding or crusting sores on the lips
- burning feeling in the chest or stomach
- chest pain
- chills
- hives or itching
- irritability
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle pain or weakness
- purple spots on the skin
- rectal bleeding
- redness, blistering, peeling, or loosening of the skin
- restlessness
- sores, ulcers, or white spots in the mouth or on the lips
- stomach upset
- swelling of the legs
- swollen glands

Some side effects of oxcarbazepine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
- Abdominal or stomach pain
- burning feeling in the chest or stomach
- nausea and vomiting
- sleepiness or unusual drowsiness

Less common
- Acid or sour stomach
- acne
- back pain
- belching
- bloody nose
- blurred vision
- change in your sense of taste
- constipation
- diarrhea
- difficulty with speaking
- dryness of the mouth
- feeling of warmth and redness of the face, neck, arms, and occasionally chest
- heartburn
- increased sweating
- increased urination
- trouble with sleeping
USUAL ADULT DOSE FOR SEIZURES

For use as adjunctive treatment or monotherapy in the treatment of partial seizures:

Adjunctive Therapy:
Initial Dose: 600 mg/day, (given as 300 mg twice a day). If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day have shown somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant antiepileptic drugs be monitored during the period of oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day.

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at 600 mg/day (given as 300 mg twice a day) while simultaneously reducing the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. Patients should be observed closely during this transition phase.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 600 mg/day (given as 300 mg twice a day); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine.

USUAL PEDIATRIC DOSE FOR SEIZURES

For use as adjunctive treatment for partial seizures in children ages 2 to 16:

Initial Dose: 8-10 mg/kg generally not to exceed 600 mg/day, (given as 300 mg twice a day). The target maintenance dose of oxcarbazepine should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:

20-29 kg: 900 mg/day

29.1-39 kg: 1200 mg/day

>39 kg: 1800 mg/day

2 to<4 years: Treatment should also be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice daily regimen.

For patients under 20 kg: A starting dose of 16 to 20 mg/kg may be considered. The
maximum maintenance dose of oxcarbazepine should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day in a twice daily regimen.

In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to
reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.

When normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to 12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.


For use as monotherapy for partial seizures in patients ages 4 to 16:

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 10 mg/kg/day given in a twice daily regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
while oxcarbazepine may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase. The recommended total daily dose of oxcarbazepine is shown below.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 10 mg/kg/day given in a twice daily regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown below.

Range of Maintenance Doses of oxcarbazepine for Children by Weight During Monotherapy:
If the patient's weight is 20 kg, then dose from 600 to 900 mg/day.
If the patient's weight is 25 kg, then dose from 900 to 1200 mg/day.
If the patient's weight is 30 kg, then dose from 900 to 1200 mg/day.
If the patient's weight is 35 kg, then dose from 900 to 1500 mg/day.
If the patient's weight is 40 kg, then dose from 900 to 1500 mg/day.
If the patient's weight is 45 kg, then dose from 1200 to 1500 mg/day.
If the patient's weight is 50 kg, then dose from 1200 to 1800 mg/day.
If the patient's weight is 55 kg, then dose from 1200 to 1800 mg/day.
If the patient's weight is 60 kg, then dose from 1200 to 2100 mg/day.
If the patient's weight is 65 kg, then dose from 1200 to 2100 mg/day.
If the patient's weight is 70 kg, then dose from 1500 to 2100 mg/day.

RENAL DOSE ADJUSTMENTS

In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response.

LIVER DOSE ADJUSTMENTS

Dose adjustments are not required in patients with mild to moderate hepatic
impairment.

DIALYSIS

In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response.

OTHER COMMENTS

All dosing should be given in a twice a day regimen.

Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

Oxcarbazepine can be taken with or without food.