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Orap Warnings and Precautions

Specific Precautions and Warnings for Orap

Some warnings and precautions to be aware of prior to taking this medicine include the following:
 
  • Because of the risks associated with its use, Orap should only be used in people with Tourette syndrome whose symptoms are severe enough to warrant medication treatment and who did not respond to, or did not tolerate, another medication known as haloperidol (Haldol®).
 
  • Orap can cause a potentially irreversible movement disorder known as tardive dyskinesia. Tardive dyskinesia is characterized by uncontrollable facial, tongue, or body movements. The risk for this side effect is highest in people who are older, receive high doses, and take the medication for long periods of time. However, the condition can happen in anyone, even at low doses and after a brief period of use. There is no well-established treatment for tardive dyskinesia. Tell your healthcare provider right away if you notice any abnormal movements during Orap treatment.
 
  • Like other antipsychotic medications, Orap may cause a rare, but life-threatening problem known as neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop signs of NMS, which may include:
 
    • A high fever or sweating
    • Confusion
    • Muscle stiffness
    • A fast or irregular heartbeat.
 
  • There have been reports of death in people who took high doses of Orap for conditions other than Tourette syndrome. It is thought that the deaths were related to a change in electrical activity of the heart known as QT prolongation. QT prolongation can lead to life-threatening heart rhythm problems. Your healthcare provider will monitor the electrical activity of your heart with an electrocardiogram (ECG) before starting Orap and periodically during treatment. Do not take more than your prescribed dose.
 
  • Orap caused tumors of the pituitary gland in animal studies, especially at high doses. At this time, it is unknown whether a similar risk exists in humans.
 
  • Like other antipsychotic medicines, Orap may cause a decrease in white blood cells, which would increase the risk for infections. Your healthcare provider may choose to monitor your white blood cell counts, especially during the first few months of treatment. If your white blood cells drop too low, you may need to stop taking Orap. Tell your healthcare provider right away if you develop any signs of an infection, such as:
 
 
  • This medication can make you drowsy and dizzy, 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.
 
  • Orap should be used with caution in people with liver or kidney disease. It should also be used with caution in people who have a history of seizures, as it can increase the risk for seizures.
 
  • This drug may cause a condition known as akathisia, which is an internal feeling of restlessness, especially at the start of treatment. People with akathisia find it very difficult to sit or stand still. Talk to your healthcare provider if you experience these symptoms while taking Orap.
 
 
  • Orap is a pregnancy Category C medication, which means it may not be safe for use during pregnancy (see Orap and Pregnancy for more information).
 
  • It is unknown whether Orap passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider before taking this medicine (see Orap and Breastfeeding).
 
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