Oxcarbatol tablets

Oxcarbatol

  • Active Ingredient: Oxcarbazepine
  • 600 mg, 300 mg, 150 mg
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What is Oxcarbatol?

The active ingredient of Oxcarbatol brand is oxcarbazepine. Oxcarbazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain. 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. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, povidone, polyethylene glycol, croscarmellose sodium, microcrystalline cellulose, crospovidone, sodium stearyl fumarate, hypromellose, polysorbate 80, titanium dioxide and yellow iron oxide.

Used for

Oxcarbatol is used to treat diseases such as: Anxiety, Bipolar Disorder, Borderline Personality Disorder, Cyclothymic Disorder, Epilepsy, Neuropathic Pain, Seizures, Trigeminal Neuralgia.

Side Effect

Possible side effects of Oxcarbatol include: pain or tenderness around the eyes or cheekbones; bloody or cloudy urine; mental depression; change in your sense of taste; false sense of well-being; dizziness.

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What are the possible s >

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Oxcarbatol.

Oxcarbatol can reduce the sodium in your body to dangerously low levels, which can cause a life-threatening electrolyte imbalance. Call your doctor right away if you have nausea, lack of energy, confusion, feeling tired or irritable, severe weakness, muscle pain, or increased 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.

Common side effects may include:

  • dizziness, drowsiness, feeling weak or tired;
  • balance or coordination problems;
  • nausea, vomiting;
  • tremors or shaking;
  • double vision; or
  • headache.

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 should I avo >

Do not drink alcohol. Drinking alcohol can increase certain side effects of Oxcarbatol. 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.

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

Suicide Risk

Oxcarbatol treatment, like other anticonvulsants, carries a risk of suic >  which is an increase in suicidal thoughts and behavior.

About one in every 500 people—both children and adults—who were treated with Trileptal for various conditions, including epilepsy and mental disorders, during various clinical studies of the drug became suicidal during treatment. Some people developed suicidal thoughts and behaviors within one week of beginning the medication.

It's important that both you and your family members or loved ones recognize this risk with Trileptal before beginning treatment, and watch for any signs of it while you are taking the drug. Contact your doctor immediately and ask your family to call your doctor immediately if you experience any of these symptoms, especially if they are new, worrisome, or become worse:

  • Panic attacks
  • Agitation or restlessness
  • New or worsening irritability, anxiety, or depression
  • Acting out dangerous impulses
  • Insomnia
  • Aggressive, angry, or violent behavior
  • Mania, which involves a notable increase in your activity level and talking
  • Thinking about or talking about harming or killing yourself
  • Withdrawing from friends and family
  • Preoccupation with death and dying
  • Giving away prized possessions
  • Any other unusual changes in behavior or mood

Make sure you see your healthcare provider for all of your follow-up appointments and that you take Trileptal exactly as directed.

Adjunctive Therapy for Pediatric Patients (Aged 2 to 16 Years)

In pediatric patients aged 4 to 16 years, initiate Oxcarbatol at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given twice-a-day. The target maintenance dose of Oxcarbatol should be achieved over 2 weeks, and is dependent upon patient weight, according to the following chart:

20 to 29 kg - 900 mg/day 29.1 to 39 kg - 1,200 mg/day >39 kg – 1,800 mg/day

In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6 to 51 mg/kg.

In pediatric patients aged 2 to . The maximum maintenance dose of Oxcarbatol should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day in a twice-a-day 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.

Under adjunctive therapy (with and without enzyme-inducing AEDs), when normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to .

COMMON BRAND(S): Trileptal

GENERIC NAME(S): Oxcarbatol

Oxcarbatol is used alone or with other medications to treat seizure disorders (epilepsy).

What other drugs will affect Oxcarbatol?

Using Oxcarbatol with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Oxcarbatol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Withdrawal of AEDs

As with most antiepileptic drugs, Oxcarbatol should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus . But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

Initiation of Monotherapy for Adults

Patients not currently being treated with AEDs may have monotherapy initiated with Oxcarbatol. In these patients, initiate Oxcarbatol at a dose of 600 mg/day (given a twice-a-day); the dose should be increased by 300 mg/day every third day to a dose of 1,200 mg/day. Controlled trials in these patients examined the effectiveness of a 1,200 mg/day dose; a dose of 2,400 mg/day has been shown to be effective in patients converted from other AEDs to Oxcarbatol monotherapy (see above).

Oxcarbatol Monotherapy Trials

Four randomized, controlled, double-blind, multicenter trials, conducted in a predominately adult population, demonstrated the efficacy of Oxcarbatol as monotherapy. Two trials compared Oxcarbatol to placebo and 2 trials used a randomized withdrawal design to compare a high dose (2,400 mg) with a low dose (300 mg) of Oxcarbatol, after substituting Oxcarbatol 2,400 mg/day for 1 or more antiepileptic drugs (AEDs). All doses were administered on a twice-a-day schedule. A fifth randomized, controlled, rater-blind, multicenter study, conducted in a pediatric population, failed to demonstrate a statistically significant difference between low and high dose Oxcarbatol treatment groups. One placebo-controlled trial was conducted in 102 patients (11 to 62 years of age) with refractory partial-onset seizures who had completed an inpatient evaluation for epilepsy surgery. Patients had been withdrawn from all AEDs and were required to have 2 to 10 partial-onset seizures within 48 hours prior to randomization. Patients were randomized to receive either placebo or Oxcarbatol given as 1,500 mg/day on Day 1 and 2,400 mg/day thereafter for an additional 9 days, or until 1 of the following 3 exit criteria occurred: 1) the occurrence of a fourth partial-onset seizure, excluding Day 1, 2) 2 new-onset secondarily generalized seizures, where such seizures were not seen in the 1-year period prior to randomization, or 3) occurrence of serial seizures or status epilepticus. The primary measure of effectiveness was a between-group comparison of the time to meet exit criteria. There was a statistically significant difference in favor of Oxcarbatol (see Figure 1), p=0.0001.

Clinical Studies

The effectiveness of Oxcarbatol as adjunctive and monotherapy for partial-onset seizures in adults, and as adjunctive therapy in children aged 2 to 16 years was established in seven multicenter, randomized, controlled trials.

The effectiveness of Oxcarbatol as monotherapy for partial-onset seizures in children aged 4 to 16 years was determined from data obtained in the studies described, as well as by pharmacokinetic/pharmacodynamic considerations.

In 2-year carcinogenicity studies, Oxcarbatol was administered in the diet at doses of up to 100 mg/kg/day to mice and by gavage at doses of up to 250 mg/kg/day to rats, and the pharmacologically active 10-hydroxy metabolite (MHD) was administered orally at doses of up to 600 mg/kg/day to rats. In mice, a dose-related increase in the incidence of hepatocellular adenomas was observed at Oxcarbatol doses ≥70 mg/kg/day or approximately 0.1 times the maximum recommended human dose (MRHD) on a mg/m² basis. In rats, the incidence of hepatocellular carcinomas was increased in females treated with Oxcarbatol at doses ≥25 mg/kg/day (0.1 times the MRHD on a mg/m² basis), and incidences of hepatocellular adenomas and/or carcinomas were increased in males and females treated with MHD at doses of 600 mg/kg/day (2.4 times the MRHD on a mg/m² basis) and ≥250 mg/kg/day (equivalent to the MRHD on a mg/m² basis), respectively. There was an increase in the incidence of benign testicular interstitial cell tumors in rats at 250 mg Oxcarbatol/kg/day and at ≥250 mg MHD/kg/day, and an increase in the incidence of granular cell tumors in the cervix and vagina in rats at 600 mg MHD/kg/day.

Strong CYP3A4 inducers or UGT inducers

  • Strong CYP3A4 inducers and/or UGT inducers decrease systemic exposure to 10-monohydroxy derivative (MHD), the active metabolite
  • Dosage adjustment of Oxcarbatol may be required after initiation, dosage modification, or discontinuation of such induce
  • Oxtellar XR: Initiate at 900 mg qDay

Before taking this medicine

You should not take Oxcarbatol if you are allergic to Oxcarbatol or eslicarbazepine.

Tell your doctor if you have ever had:

mood problems or suicidal thoughts; or

Some people have thoughts about suicide while taking Oxcarbatol. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking Oxcarbatol during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking Oxcarbatol for seizures.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Oxcarbatol on the baby.

Oxcarbatol can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breast-feed while you are taking Oxcarbatol.

Do not give this medicine to a child without medical advice. There are specific age restrictions for the use of Oxcarbatol in children, depending on the dose form and whether it is used alone or with other medicines.

Seizure drugs

Taking Oxcarbatol with phenytoin increases phenytoin levels in your blood. This raises your risk of side effects from phenytoin. Your doctor may decrease your dosage of phenytoin if you take it with Oxcarbatol.

Certain seizure drugs decrease the level of Oxcarbatol in your body. If you take Oxcarbatol with these drugs, Oxcarbatol may not work as well to treat your seizures. Your doctor may increase your dosage of Oxcarbatol if you take it with these drugs. Examples of these drugs include:

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Oxcarbatol (Trileptal)

Oxcarbatol , the keto-analogue of carbamazepine, was developed to preserve carbamazepine’s membrane-stabilizing effects while minimizing minor adverse effects, such as sedation and serious or life-threatening reactions. A major advantage of Oxcarbatol is that monitoring of drug plasma levels and hematologic profiles is generally not necessary. Similar to carbamazepine, Oxcarbatol blocks sodium channels; it does not affect gamma-aminobutyric acid (GABA) receptors.

Significant hyponatremia (sodium 14 They were treated with 300 mg/day that was titrated to a maximum of 1800 mg/day. Oxcarbatol-treated patients reported less pain on VAS, global improvement, and less sleep disturbances due to pain.

The superior side-effect profile of Oxcarbatol compared with carbamazepine has led to its increased use. Although it is better tolerated, there is still a significant incidence of adverse effects. In a retrospective review of 100 patients successfully treated for trigeminal neuralgia with oxycarbazepine, there was an 18% discontinuation rate secondary to adverse effects. 13 In several countries Oxcarbatol is now the drug of choice for trigeminal neuralgia. Although a case series reported its efficacy in the treatment of neuropathic pain, 13 prospective randomized controlled studies are lacking at this time.

Oxcarbatol Adjunctive Therapy Trials

The effectiveness of Oxcarbatol as an adjunctive therapy for partial-onset seizures was established in 2 multicenter, randomized, double-blind, placebo-controlled trials, one in 692 patients (15 to 66 years of age) and one in 264 pediatric patients (3 to 17 years of age), and in one multicenter, rater-blind, randomized, age-stratified, parallel-group study comparing 2 doses of Oxcarbatol in 128 pediatric patients (1 month to Table 8: Summary of Percentage Change in Partial-Onset Seizure Frequency from Baseline for Placebo-Controlled Adjunctive Therapy Trials Trial Treatment Group N Baseline Median Seizure Rate* Median % Reduction 1 (pediatrics) Oxcarbatol 136 12.5 34.8 1 Placebo 128 13.1 9.4 2 (adults) Oxcarbatol 2,400 mg/day 174 10 49.9 1 Oxcarbatol 1,200 mg/day 177 9.8 40.2 1 Oxcarbatol 600 mg/day 168 9.6 26.4 1 Placebo 173 8.6 7.6

1 p=0.0001; * = number of seizures per 28 days

Subset analyses of the antiepileptic efficacy of Oxcarbatol with regard to gender in these trials revealed no important differences in response between men and women. Because there were very few patients over the age of 65 years in controlled trials, the effect of the drug in the elderly has not been adequately assessed.

The third adjunctive therapy trial enrolled 128 pediatric patients (1 month to


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