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.
| Stelazine | |||
| Trifluoperazine Hydrochloride | |||
Symptoms of a trifluoperazine overdose include uncontrollable movements, agitation, seizures, severe dizziness or fainting, coma, very deep sleep, irregular heartbeats, and high or low body temperature.
Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.
Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking trifluoperazine. Avoid prolonged exposure to sunlight. Trifluoperazine may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when sun exposure is unavoidable.an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
uncontrollable movements of the tongue, face, lips, arms, or legs;
muscle spasms of the face or neck;
severe restlessness or tremor;
severe drowsiness or fainting; or
a rash.
Other, less serious side effects may be more likely to occur. Continue to take trifluoperazine and talk to your doctor if you experience
dry mouth or a stuffy nose;
blurred vision;
mild restlessness, drowsiness, or tremor;
difficult urination, dark urine;
decreased sex drive;
dizziness;
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.
Trifluoperazine also interacts with medications other than the ones listed here. Before taking trifluoperazine, tell your doctor about all other prescription and over-the-counter medicines you are taking, including herbal products. During treatment, do not start taking any new drug without first talking to your doctor.
Your pharmacist has additional information about trifluoperazine written for health professionals that you may read.
Trifluoperazine is available with a prescription under the brand name Stelazine. 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.
Stelazine 1 mg--round, blue, coated tablets
Stelazine 2 mg--round, blue, coated tablets
Stelazine 5 mg--round, blue, coated tablets
Stelazine 10 mg--round, blue, coated tablets
Stelazine Concentrate10 mg/ 1 mL--clear, yellow, banana-vanilla-flavored liquid
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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