Navane Warnings and Precautions

Before starting a new drug, it is important to be aware of its potential risks. Navane warnings and precautions relate to things such as an increased risk of liver or eye damage, an impaired ability to drive a car, and possible drug interactions in some people who take the medicine. Also, certain people -- such as those with a blood disorder, those in a decreased state of consciousness, and those who are allergic to Navane or its inactive components -- should avoid the medication completely.

Navane: What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Navane® (thiothixene) if you have:
 
Also let your healthcare provider know if you:
 
  • Are pregnant or thinking of becoming pregnant
  • Drink alcohol.
     
You should also be sure to tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 

Some Navane Warnings and Precautions

Some warnings and precautions to be aware of with Navane include:
 
  • The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of Navane in elderly people with dementia (a condition involving confusion; disorientation; and a loss of memory, intellect, and judgment) or psychosis. Elderly people with dementia (Alzheimer's disease is the most common form of dementia) who are treated with antipsychotics (such as Navane) are more likely to die (of various causes) than those who were not treated with those medications. Navane is not approved to treat dementia or dementia-related psychosis, and caution should be used before using Navane in elderly people with dementia.

 

  • Navane can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:

 

    • A high fever
    • Stiff muscles
    • Confusion
    • Irregular pulse or blood pressure
    • A fast heart rate (tachycardia)
    • Sweating
    • Irregular heart rhythms (arrhythmias).
Tell your healthcare provider right away if you think you might have NMS.
  • Navane can cause tardive dyskinesia, a condition involving unusual, uncontrollable body or face movements. The condition can become permanent (even if Navane is stopped). The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking Navane.
     
  • Navane can impair your mental or physical abilities to drive a car or operate heavy machinery. Make sure you know how Navane affects you before you do any activities that require mental concentration or physical coordination.
     
  • Navane can increase the risk of liver damage or eye damage. Be sure to let your healthcare provider know if you have signs of liver damage (such as yellow eyes or skin) or any vision changes.
     
  • Navane can cause a drop in blood pressure (hypotension). This can cause a person to have lightheadedness or dizziness, or to faint. Tell your healthcare provider if you have any of these symptoms when standing. Hypotension can be especially dangerous in people with heart disease or congestive heart failure (CHF). Combining alcohol with Navane can also increase the risk of hypotension (see Alcohol and Navane).
     
  • Navane may increase the risk of seizures. Before starting Navane, tell your healthcare provider if you have epilepsy or a history of seizures.

 

  • Antipsychotics like Navane have been reported to cause low white blood cells. Let your healthcare provider know if you develop frequent or persistent infections, as this may be a sign of low white blood cells. If you already have a low white blood cell count (or have had such a problem in the past), your healthcare provider should monitor your white blood cell count frequently during the first few months you take Navane. 

 

  • Navane is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Be sure to talk with your healthcare provider about the risks and benefits of using Navane during pregnancy (see Navane and Pregnancy).
     
  • It is not known if Navane passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about using Navane (see Navane and Breastfeeding for more information).
     
  • Navane can interact with certain other medications (see Navane Drug Interactions).
 
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