Oxtella XR

Generic name: Oxcarbazepine
Dosage form: oral extended-release tablet
Drug class: Dibenzazepine anticonvulsants

Usage of Oxtella XR

Oxtellar XR (oxcarbazepine) is a once-a-day anticonvulsant drug used to treat partial-onset seizures in people with epilepsy. Oxtellar XR is an extended-release tablet, which means it slowly releases the drug steadily over the course of the day.

After you take Oxtellar XR, your body processes the drug into an active form called licarbazepine - a metabolite - that is responsible for most of Oxtellar XR's antiepileptic activity. Oxcarbazepine undergoes a process called metabolism to produce licarbazepine, its active 10-monohydroxy metabolite (MHD).

Oxtellar XR works to help prevent seizure spread in the intact brain. During a seizure many neurons or nerve cells fire at the same time, creating a surge of excessive electrical activity. Oxtellar XR is thought to work by blocking voltage-sensitive sodium channels (VSSC).

VSSC are integral membrane proteins that play key roles in the electrical signaling of cells. It's thought that by blocking VSSC, Oxtellar XR helps to stabilize hyper-excited nerve cell membranes, stop repetitive neuronal firing and diminish impulses between nerve cells. Oxtellar XR also affects calcium channels and increases potassium conductance, and this may also contribute to its antiepileptic activity.

Oxtellar XR was approved by the US Food and Drug Administration (FDA) in 2012. No generic versions of Oxteallar XR are available.

Oxtella XR side effects

See " Important information" above.

Oxtellar XR may cause other serious side effects including seizures that can happen more often or become worse, especially in children.

The most common side effects of Oxtellar XR include:

dizziness

sleepiness

headache

balance problems

tremors

vomiting

double vision

weakness or lack of energy (asthenia)

These are not all the possible side effects of Oxtellar XR. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

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

Before taking Oxtella XR

Tell your doctor if you are pregnant or plan to become pregnant. Oxtellar XR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Oxtellar XR. You and your healthcare provider will decide if you should take Oxtellar XR while you are pregnant.

If you become pregnant while taking Oxtellar XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Tell your doctor if you are breastfeeding or plan to breastfeed. Oxtellar XR passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Oxtellar XR.

Relate drugs

How to use Oxtella XR

The recommended dose of Oxtellar XR for adults and pediatric patients when used as monotherapy or adjuvant therapy are listed below.

Adults

Initiate treatment at a dosage of 600 mg a day given orally once daily for one week. Subsequent dosage increases can be made at weekly intervals in 600 mg a day increments to achieve the recommended daily dosage.

The recommended daily dosage of Oxtellar XR is 1200 mg to 2400 mg a day, given once daily.

Pediatric Patients (6 to Less than 17 Years of Age)

Initiate treatment at a daily dosage of 8 mg/kg to 10 mg/kg orally once daily, not to exceed 600 mg per day in the first week. Subsequent dosage increases can be made at weekly intervals in 8 mg/kg to 10 mg/kg increments once daily, not to exceed 600 mg, to achieve the target daily dosage.

The target maintenance dosage, achieved over two to three weeks, is displayed in the table below. Target Daily Dosage in Pediatric Patients (6 to Less Than 17 Years of Age) Weight Target Daily Dose 20 kg to 29 kg 900 mg/day 29.1 kg to 39 kg 1200 mg/day Greater than 39 kg 1800 mg/day

See full prescribing information for more information about Oxtellar XR dosing.

Warnings

Do not stop taking Oxtellar XR without first talking to your healthcare provider. Stopping Oxtellar XR suddenly can cause serious problems.

Oxtellar XR can cause serious side effects, including:

Oxtellar XR may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include:

nausea

tiredness, lack of energy

headache

confusion

more frequent or more severe seizures Similar symptoms that are not related to low sodium may occur from taking Oxtellar XR. You should tell your healthcare provider if you have any of these side effects and if they bother you or they do not go away. Some other medicines can also cause low sodium in your blood. Be sure to tell your healthcare provider about all the other medicines that you are taking. Your healthcare provider may do blood tests to check your sodium levels during your treatment with Oxtellar XR .

Oxtellar XR may also cause allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following:

swelling of your face, eyes, lips, or tongue

trouble swallowing or breathing

a skin rash

hives

fever, swollen glands, or sore throat that does not go away or comes and goes

painful sores in the mouth or around your eyes

yellowing of your skin or eyes

unusual bruising or bleeding

severe fatigue or weakness

severe muscle pain

frequent infections that do not go away Many people who are allergic to Carbamazepine are also allergic to Oxtellar XR. Tell your healthcare provider if you are allergic to carbamazepine.

Like other antiepileptic drugs, Oxtellar XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying

attempts to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks

trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking Oxtellar XR without first talking to a healthcare provider.

Stopping Oxtellar XR suddenly can cause serious problems.

Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What other drugs will affect Oxtella XR

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Oxtellar XR with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take:

carbamazepine

phenobarbital

phenytoin

birth control medicine

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.