Special Alerts:
[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics, http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01851.html.
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs; or
yellowing of your skin or eyes.
Other, less serious side effects may be more likely to occur. Continue to take thiothixene and talk to your doctor if you experience
dizziness or drowsiness,
headache,
weakness or tremor (shaking),
agitation,
an increased heart rate,
dry mouth, or
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Thiothixene may increase the side effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (medicines that treat insomnia), pain relievers, anxiety medicines, muscle relaxants, and any other drug that makes you feel sleepy or relaxed. Tell your doctor about all medicines that you are taking and do not take any medicine unless your doctor approves.
Drugs other than those listed here may also interact with thiothixene. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Your pharmacist has more information about thiothixene written for health professionals that you may read.
Thiothixene is available with a prescription generically and under the brand name Navane. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Navane 1 mg--yellow and orange capsules
Navane 2 mg-- yellow and blue capsules
Navane 5 mg--orange and white capsules
Navane 10 mg--blue and white capsules
Navane 20 mg--dark-blue and light-blue capsules
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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