Oxcarbazepine

By Medically reviewed by hellodoktor

Generic Name: Oxcarbazepine Brand Name(s): Oxcarbazepine.

Uses

What is Oxcarbazepine used for?

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

How should I take Oxcarbazepine?

Take this medication by mouth with or without food as directed by your doctor, usually twice daily. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Children’s dosage is also based on weight. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your seizures worsen.

How do I store Oxcarbazepine?

Oxcarbazepine is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Oxcarbazepine in the bathroom or the freezer. There may be different brands of Oxcarbazepine that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

Throw away any unused liquid 7 weeks after opening the bottle. You should not flush Oxcarbazepine down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Oxcarbazepine?

Before taking oxcarbazepine, tell your doctor or pharmacist if you are allergic to it; or to carbamazepine or eslicarbazepine; 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mineral imbalance (low level of sodium in the blood).

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Younger children may be more sensitive to the side effects of this drug, especially infections.

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, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. Since hormonal birth control 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Oxcarbazepine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Oxcarbazepine. Oxcarbazepine is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Oxcarbazepine?

Dizziness, drowsiness, tiredness, nausea/vomiting, stomach/abdominal pain, headache, trouble sleeping, or constipation may occur. If any of these effects last or get worse, tell 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 right away 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 right away if you have any serious side effects, including: loss of coordination, vision changes (such as double vision), rapid/uncontrollable eye movements, shaking (tremor), easy bleeding/bruising, unusual tiredness.

Get medical help right away if you have any very serious side effects, including: signs of infection (such as fever, swollen lymph nodes, sore throat that doesn’t go away, cough), symptoms of low sodium level (severe nausea, extreme drowsiness, confusion, seizures).

Oxcarbazepine may rarely cause very serious (possibly fatal) skin reactions. Some people in certain ethnic groups (including people of Asian/South Asian descent) are at greater risk. Your doctor may order a blood test to measure your risk before you start this medication. If the blood test shows you are at greater risk, your doctor should discuss the risks and benefits of oxcarbazepine and other treatment choices with you. Such skin reactions have developed mostly within the first few months of treatment. Get medical help right away if you develop symptoms of a serious skin reaction such as skin rash/blisters/peeling, itching, or swelling. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Oxcarbazepine?

A product that may interact with this drug is: orlistat.

This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cobicistat, elvitegravir, certain drugs used to treat chronic hepatitis C (such as simeprevir, sofosbuvir), rilpivirine, among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and narcotic pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Oxcarbazepine is very similar to eslicarbazepine. Do not use medications containing eslicarbazepine while using oxcarbazepine.

Oxcarbazepine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Oxcarbazepine?

Oxcarbazepine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Oxcarbazepine?

Oxcarbazepine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Oxcarbazepine.

What is the dose of Oxcarbazepine for an adult?

Usual Adult Dose for Epilepsy

Monotherapy:

Initiation of monotherapy:

Immediate-release:

Initial dose: 300 mg orally twice a day, increased by increments of 300 mg per day every third day as clinically indicated

Maintenance dose: 300 to 1,200 mg orally twice a day

Maximum dose: 1,200 mg orally twice a day

Conversion to monotherapy:

Immediate-release:

Initial dose: 300 mg orally twice a day, increased by increments of up to 600 mg per day at approximately weekly intervals as clinically indicated

Maintenance dose: 300 to 1,200 mg orally twice a day

Maximum dose: 1,200 mg orally twice a day

Comments:

-When converting to oxcarbazepine monotherapy, concomitant antiepileptics should be completely withdrawn over 3 to 6 weeks, while a maximum dose should be reached in about 2 to 4 weeks.

-Patients should be closely observed during the transition from adjunctive to monotherapy with oxcarbazepine.

Adjunctive Therapy:

Immediate-release:

Initial dose: 300 mg orally twice a day, increased by increments of up to 600 mg per day at approximately weekly intervals as clinically indicated

Maintenance dose: 300 mg to 1,200 mg orally twice a day

Maximum dose: 1,200 mg orally twice a day

Extended-release:

Initial dose: 600 mg orally once a day for one week, increased by increments of 600 mg per day at weekly intervals as clinically indicated

Maintenance dose: 1,200 to 2,400 mg orally once a day

Maximum dose: 2,400 mg orally once a day

Comments:

-Immediate release: Plasma levels of concomitant antiepileptic drugs should be monitored during titration of oxcarbazepine. In controlled trials, most patients were not able to tolerate a dose of 2,400 mg per day, mainly due to CNS effects.

-Extended-release: A dose of 2,400 mg per day showed slightly greater efficacy than 1,200 mg per day; however, it was associated with an increased risk of side effects.

Use(s): Monotherapy or adjunctive therapy for the treatment of partial seizures; extended-release oral tablets are only indicated as adjunctive therapy.

Usual Geriatric Dose for Epilepsy

Extended-release:

Initial dose: 300 to 450 mg orally once a day, increased by increments of 300 to 450 mg per day at weekly intervals as clinically indicated.

Use(s): Extended-release oral tablets are only indicated as adjunctive therapy for the treatment of partial seizures

Renal Dose Adjustments

Adults:

CrCl 29 mL/min or less:

Immediate-release:

Initial dose: 150 mg orally twice a day; increase at a slower than usual rate as clinically indicated

Extended-release:

Initial dose: 300 mg orally once a day; increase in increments of 300 to 450 mg per day at weekly intervals as clinically indicated

Liver Dose Adjustments

Immediate-release:

Mild to moderate liver dysfunction: No adjustment recommended

Extended-release:

Severe liver dysfunction: Data not available

Dose Adjustments

Treatment withdrawal: Oxcarbazepine should be withdrawn gradually to minimize the potential for increased seizure frequency.

Conversion from immediate-release to extended-release oral oxcarbazepine: Greater doses of extended-release oxcarbazepine may be required.

Extended-release: The manufacturer recommends that an increased initial oxcarbazepine dose of 900 mg orally once a day be considered when given concomitantly with enzyme-inducing antiepileptic medicines.

Dialysis

Extended-release: Use is not recommended

Other Comments

Administration advice:

Immediate-release oral formulations:

-Doses may be taken with or without food

-The bottle containing the oral suspension should be shaken well immediately before preparing the dose

-Oxcarbazepine oral suspension may be swallowed directly from the oral dosing syringe provided with the bottle or mixed in a small glass of water just prior to administration.

Extended-release oral formulation:

-Doses should be swallowed whole and not cut, crushed or chewed

-Doses should be taken at least 1 hour before or 2 hours after meals

-For adults or pediatric patients with difficulty swallowing, daily doses may be achieved using multiples of the appropriate lower strength tablets, e.g., 150 mg tablets.

Storage requirements:

-Oxcarbazepine oral suspension should be stored at 25 C (77 F) and used within 7 weeks of opening.

General:

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

-Plasma levels of concomitant antiepileptic drugs may be altered during concomitant therapy with oxcarbazepine, particularly at doses greater than 1,200 mg per day

-There may be an increased risk of side effects if extended-release oxcarbazepine is taken with food, due to an increase in peak levels.

-Regardless of concomitant antiepileptic therapy, apparent clearance (L/hr/kg; normalized by body weight) decreases with increasing age.

-Compared to adults, children from 2 to 3 years of age may require up to twice the oxcarbazepine dose per body weight, and children 4 to 12 years may require a 50% greater dose per body weight.

-In the clinical trials 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.

Monitoring:

-Dermatologic: Serious dermatologic reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis

-Hypersensitivity: Hypersensitivity reactions, particularly in patients with prior hypersensitivity reactions to carbamazepine

-Metabolic: Hyponatremia

-Nervous system: Seizures, somnolence, dizziness

-Pregnancy: Planned or unplanned pregnancy

-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior

Patient advice:

-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.

-Antiepileptic drugs, including this medicine, may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.

-This medicine may cause drowsiness and dizziness; do not drive a car or operate dangerous machinery until you know how this drug affects you.

-Do not drink alcohol or take other medicines that may cause sleepiness or dizziness while taking this medicine until you talk to your healthcare provider.

What is the dose of Oxcarbazepine for a child?

Usual Pediatric Dose for Epilepsy

Monotherapy:

4 to 16 years of age:

Immediate-release:

Initiation of monotherapy: 4 to 5 mg/kg orally twice a day (up to 600 mg per day), increased by an increment of 5 mg/kg per day every third day as clinically indicated

Conversion to monotherapy: 4 to 5 mg/kg orally twice a day (up to 600 mg per day), increased by an increment of 10 mg/kg per day at approximately weekly intervals as clinically indicated

Maintenance dose:

Body weight:

20 kg: 300 to 450 mg orally twice a day

25 to 30 kg: 450 to 600 mg orally twice a day

35 to 40 kg: 450 to 750 mg orally twice a day

45 kg: 600 to 750 mg orally twice a day

50 to 55 kg: 600 to 900 mg orally twice a day

60 to 65 kg: 600 to 1,050 mg orally twice a day

70 kg: 750 to 1,050 mg orally twice a day

Comments:

-When converting to oxcarbazepine monotherapy, concomitant antiepileptics may be completely withdrawn over 3 to 6 weeks.

-Patients should be closely observed during the transition phase.

Adjunctive therapy:

2 to 4 years of age:

Immediate-release:

Initial dose:

Body weight:

20 kg or more: 4 to 5 mg/kg orally twice a day (up to 600 mg per day)

Less than 20 kg: 8 to 10 mg/kg orally twice a day

Maximum dose: 30 mg/kg orally twice a day

Comments:

-The maximum recommended dose should be achieved over 2 to 4 weeks

4 to 16 years of age:

Immediate-release:

Initial dose: 4 to 5 mg/kg orally twice a day (up to 600 mg per day)

Maintenance dose:

Body weight:

20 to 29 kg: 900 mg orally per day

29.1 to 39 kg: 1,200 mg orally per day

Greater than 39 kg: 1,800 mg orally per day

Comments:

-The target maintenance dose should be achieved over 2 weeks

6 to 17 years of age:

Extended-release:

Initial dose: 8 to 10 mg/kg (up to 600 mg) orally once a day, increased by an increment of 8 to 10 mg/kg per day (up to 600 mg) at weekly intervals if clinically indicated

Maintenance dose:

Body weight:

20 to 29 kg: 900 mg orally once a day

29.1 to 39 kg: 1,200 mg orally once a day

Greater than 39 kg: 1,800 mg orally once a day

Comments:

-Use is not recommended in patients younger than 6 years of age due to tablet size; data are not available in patients younger than 4 years of age.

Use(s): Monotherapy for the treatment of partial seizures in children 4 to 16 years; adjunctive therapy for the treatment of partial seizures in children 2 to 16 years; extended-release oral tablets are only indicated as adjunctive therapy.

Precautions

Safety and efficacy have not been established in patients younger than 2 years of age (immediate-release oral tablets) and 6 years of age (extended-release oral tablets). Immediate-release oral tablets are only indicated for adjunctive therapy in children over 2 years of age and as monotherapy in children over 4 years of age. Extended-release oral tablets are only indicated for adjunctive therapy in patients over 6 years of age.

How is Oxcarbazepine available?

Oxcarbazepine is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral suspension,
  • Oral tablet, extended release.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Oxcarbazepine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 5, 2018 | Last Modified: September 12, 2019

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