Nexterone Warnings and Precautions

Specific Precautions and Warnings With Nexterone

Some warnings and precautions to be aware of prior to using this drug include the following:
  • Nexterone is an effective medicine for controlling arrhythmias. However, it is associated with potentially serious and life-threatening side effects. Therefore, it should only be given by a healthcare provider who has experience treating life-threatening arrhythmias with Nexterone, and who has access to appropriate medical facilities necessary for adequate monitoring of treatment.
  • Nexterone may cause a significant and potentially life-threatening drop in blood pressure (hypotension) and heart rate (bradycardia). The risk for these reactions is higher if the infusion (a slow injection into a vein) is given too quickly. If you develop hypotension or bradycardia, your healthcare provider will slow down the rate of your infusion, or stop the medication altogether. You may also need additional medicines to return your blood pressure to normal or a pacemaker to help control your heartbeat.
  • This medication may cause liver injury that, in some cases, can be life-threatening. Let your healthcare provider know right away if you have symptoms of liver problems, such as:
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice)
    • Upper-right abdominal (stomach) pain
    • Nausea and vomiting
    • Extreme tiredness.
  • In a clinical study, people who took certain antiarrhythmia medicines, such as Nexterone, after having a heart attack had a higher risk of their heart stopping and death than people who did not take the antiarrhythmia medications. It is unknown whether people who have not had a recent heart attack have the same risk.
  • Because of the potential risks associated with its use, and because Nexterone has not been shown to help people with arrhythmias live longer, the medication should only be used to treat life-threatening ventricular arrhythmias in people who have not responded to or could not tolerate other arrhythmia medicines.
  • This medicine can cause serious thyroid problems, including an under- or overactive thyroid (hypothyroidism or hyperthyroidism, respectively). There have also been reports of thyroid cancer in people taking amiodarone (the active ingredient in Nexterone). Your healthcare provider will check your thyroid function using a blood test before and periodically during treatment. Let your healthcare provider know immediately if you develop signs of thyroid problems, such as:
    • Weakness
    • Unexplained weight loss or weight gain
    • An intolerance to hot or cold temperatures
    • Thinning of your hair
    • Sweating
    • Changes in your menstrual period
    • Swelling in your neck
    • Tremor
    • Feelings of nervousness, restlessness, or irritability
    • Problems concentrating.
  • Like other antiarrhythmia medicines, Nexterone could worsen your existing heart rhythm problem or cause a different heart rhythm problem, including a potentially life-threatening abnormal heart rhythm known as torsades de pointes. Let your healthcare provider know if you experience any abnormal heart rates during treatment, such as a fast, slow, forceful, or irregular heartbeat.
  • This medication can cause serious and potentially life-threatening lung problems. Tell your healthcare provider right away if you experience any lung problems, such as:
    • Shortness of breath
    • Wheezing
    • Coughing
    • Chest pain
    • Coughing up blood.
  • If you are having surgery, including eye or dental surgery, it is very important to tell your healthcare provider that you are using, or have recently used, Nexterone, even if you stopped using it months ago. You will need to be monitored more closely than usual, as you may be more sensitive to general anesthesia. In addition, many laser eye surgeries cannot be performed on people using Nexterone.
  • Nexterone can cause you to have abnormal thyroid test results, even months after you stop using it. Make sure all of your healthcare providers know that you have received this medication.
  • Low blood potassium or magnesium levels can increase your risk for heart rhythm problems from Nexterone. Therefore, your healthcare provider will monitor your potassium and magnesium levels during treatment.
  • Nexterone may cause vision problems that, in some cases, could lead to permanent blindness. Let your healthcare provider know right away if you develop vision problems, such as:
    • Blurred vision
    • Seeing halos
    • Problems with peripheral vision
    • Sensitivity to the light.
  • Nexterone is a pregnancy Category D medication. This means it may harm an unborn child (see Nexterone and Pregnancy).
  • Nexterone passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Nexterone and Breastfeeding).
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