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Precautions and Warnings With Oxcarbazepine Extended-Release

If you have kidney problems or other medical issues, talk to your healthcare provider about whether oxcarbazepine extended-release may increase your risk for certain complications. This drug is not suitable for everyone; in some cases, it can cause blood problems, dangerous skin reactions, or potentially life-threatening problems. Warnings and precautions also apply to women who are pregnant or nursing.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking oxcarbazepine extended-release (Oxtellar XR™) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure (renal failure)
  • Low blood sodium levels (hyponatremia)
  • Thoughts of suicide or of harming yourself
  • Depression or other mood problems
  • Anemia (low red blood cell count) or other blood problems
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Oxcarbazepine Extended-Release Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • This medication can cause low blood sodium levels (known medically as hyponatremia). Hyponatremia can occur at any time, but is more likely to happen within the first three months of treatment. Your healthcare provider may choose to monitor your blood sodium levels using with a simple blood test. Also, let your healthcare provider know if you have signs of low blood sodium levels, such as:
    • Nausea
    • Loss of appetite
    • Tiredness or low energy
    • Headaches
    • Confusion
    • Irritability
    • Muscle weakness
    • Muscle cramps or spasms
    • More frequent or more severe seizures.
  • In rare cases, some people may develop a severe allergic reaction to oxcarbazepine extended-release. The reactions can sometimes happen as soon as after the first dose. Stop taking this medication and seek immediate medical attention if you have signs of an allergic reaction to oxcarbazepine extended-release, such as:
    • An unexplained rash
    • Hives
    • Unexplained swelling, especially of the face, eyes, lips, or throat
    • Difficulty breathing or swallowing.
  • About 25 to 30 percent of people who are allergic to carbamazepine (Carbatrol®, Epitol®, Equetro®, Tegretol®) will also be allergic to oxcarbazepine extended-release. Let your healthcare provider know if you have ever had an allergic reaction to carbamazepine. Your healthcare provider will need to consider the risks and benefits of treating you with oxcarbazepine extended-release before starting treatment.
  • This medication may cause very serious skin reactions, including potentially life-threatening skin rashes known as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Contact your healthcare provider immediately if you notice any unexplained skin rash, redness, or peeling of the skin while taking this medication.
  • All anti-seizure medicines (antiepileptic medicines), including oxcarbazepine extended-release, may increase the risk for suicidal thoughts and behavior, regardless of the reason they are being used. Let your healthcare provider know right away if you experience any unusual changes in your mood or behavior, new or worse depression, or have thoughts of suicide or harming yourself while taking this medicine (see Seizure Medications and Suicide).
  • Do not stop taking this medication suddenly, as doing so could increase your risk for having seizures. If you will no longer be taking oxcarbazepine extended-release, your healthcare provider will slowly decrease your dosage.
  • This medication can cause serious hypersensitivity reactions (allergic-type reactions) that can affect multiple parts of the body, including the blood, liver, kidneys, muscles, joints, nervous system, and lungs. These reactions can be life-threatening and may lead to a hospital stay. Most people will have a fever and rash, along with other symptoms; however, the other symptoms can vary significantly from person to person.

    Let your healthcare provider know immediately if you have signs of a hypersensitivity reaction to oxcarbazepine extended-release, such as:
    • Fever
    • Rash
    • Hives
    • Unexplained swelling, especially of the face, eyes, lips, or throat
    • Painful sores in the mouth or around the eyes
    • Unusual bleeding or bruising
    • Swollen or enlarged lymph nodes
    • Recurring infections or infections that do not go away
    • Abdominal pain (stomach pain)
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Severe muscle or joint pain
    • Severe fatigue or weakness
    • Confusion
    • Shortness of breath or difficulty breathing.
  • Oxcarbazepine extended-release can cause blood problems, including a decrease in blood cell counts. Your healthcare provider may choose to monitor your blood cell counts during treatment. Let your healthcare provider know if you have signs of low blood cell counts, such as:
    • Signs of infection, such as:
    • Signs of anemia, such as:
      • Weakness
      • Fatigue
      • Shortness of breath
      • Pale skin
    • Any unexplained bleeding or bruising.
  • This medication can cause significant sedation and dizziness, which could affect your thinking, judgment, and motor skills. Do not perform any activities that require mental alertness, such as driving or operating heavy machinery, until you know how this medication affects you. In addition, alcohol can add to these effects. Therefore, use caution if you will be consuming alcohol during oxcarbazepine extended-release treatment.
  • Oxcarbazepine extended-release is a pregnancy Category C medication, which means it may not be safe for use during pregnancy. If you will be treated with this medication during pregnancy, you will need to be monitored closely, as blood levels of the drug can decrease throughout pregnancy (see Oxtellar XR and Pregnancy).
  • This medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Oxtellar XR and Breastfeeding).
Know the Signs - Concussion Safety

Oxcarbazepine Extended-Release Information

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