(characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS) has occurred in a few patients treated with lithium plus an antipsychotic In some instances, the syndrome was followed by irreversible brain damage; because of a possible causal relationship between these events and concomitant administration of lithium and antipsychotics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS); patients who have demonstrated a hypersensitivity reaction (eg, blood dyscrasias, jaundice) with a phenothiazine should not be reexposed to any phenothiazine, including trifluoperazine hydrochloride unless in judgment of physician the potential benefits of treatment outweigh possible hazard This drug may impair mental and/or physical abilities, especially during first few days of therapy; therefore, caution patients about activities requiring alertness (eg, operating vehicles or machinery); if agents such as sedatives, narcotics, anesthetics, tranquilizers, or alcohol are used either simultaneously or successively with the drug, the possibility of an undesirable additive depressant effect should be considered Pregnancy Safety for use during pregnancy not established; not recommended that the drug be given to pregnant patients except when, in judgment of physician, it is essential; potential benefits should clearly outweigh possible hazards There are reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia, or hyporeflexia in newborn infants whose mothers received phenothiazines Neonates exposed to antipsychotic drugs, during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery; there have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates; these complications have varied in severity While in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization; this drug should be used during pregnancy only if potential benefit justifies potential risk to fetus Animal data Reproductive studies in rats given over 600 times human dose showed increased incidence of malformations above controls and reduced litter size and weight linked to maternal toxicity; these effects were not observed at half this dosage; no adverse effect on fetal development was observed in rabbits given 700 times human dose nor in monkeys given 25 times human dose Lactation There is evidence that phenothiazines are excreted in breast milk of nursing mothers; because of potential for serious adverse reactions in nursing infants from this drug, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account importance of drug to motherPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Piperazine phenothiazine agent; antagonist for the postsynaptic mesolimbic dopaminergic D2 receptors in the brain; decreases the release of hypothalamic and hypophyseal hormones Pharmacokinetics Half-Life elimination: 24 hr Metabolism: Liver BRAND FORM. UNIT PRICE PILL IMAGE trifluoperazine oral- 5 mg tablettrifluoperazine oral- 5 mg tablettrifluoperazine oral- 1 mg tablettrifluoperazine oral- 10 mg tablettrifluoperazine oral- 2 mg tablettrifluoperazine oral- 1 mg tablettrifluoperazine oral- 10 mg tablettrifluoperazine oral- 2 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationtrifluoperazine oral TRIFLUOPERAZINE - ORAL (TRYE-floo-oh-PER-a-zeen) COMMON BRAND NAME(S): Stelazine WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor. USES: This medication is used to treat certain mental/mood disorders (such as schizophrenia, psychotic disorders). Trifluoperazine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggressive behavior and the desire to hurt yourself/others. It may also help to decrease hallucinations (hearing/seeing things that are not there). Trifluoperazine is a psychiatric medication that belongs to the class of drugs called phenothiazine antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.This medication has also been used for the short-term treatment of anxiety. However, there are safer drugs to treat anxiety that should be used first before trifluoperazine. HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.Dosage is based on your medical condition, age, and response to treatment. In children, the dosage is also based on weight. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Although you may notice some medication effects soon after starting, it may take 2 to 3 weeks before you get the full benefit of this drug.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as upset stomach, nausea, vomiting, dizziness, and shakiness. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, dry mouth, blurred vision, tiredness, constipation, weight gain, and trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor right away if you notice any of the following side effects: feelings of anxiety/agitation/jitteriness, drooling/trouble swallowing, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), mask-like expression of the face.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: difficulty urinating, decreased cough reflex, swelling of the feet/ankles, butterfly-shaped rash on nose and cheeks, joint pain, skin discoloration, eye/vision changes, feeling unusually cold or hot, signs of liver problems (such as nausea that doesn't stop, yellowing eyes/skin, vomiting, stomach/abdominal pain), signs of infection (such as sore throat that doesn't go away, fever), easy bruising/bleeding, signs of anemia (such as severe tiredness, fast breathing, pale skin, fast heartbeat), mental/mood changes (such as worsening psychosis, unresponsive/catatonic state).Rarely, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor right away if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.In rare cases, trifluoperazine may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.Get medical help right away if you have any very serious side effects, including: slowed breathing, chest pain, seizures.This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking trifluoperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, heart problems (such as mitral valve insufficiency, abnormal heart rhythm, angina), low blood pressure, blockage of the intestines, glaucoma, seizures, enlarged prostate, breathing problems (such as severe asthma, emphysema, lung infections), blood disorders (such as bone marrow depression, low red/white/platelet blood cell counts), low levels of calcium in the blood, dehydration, breast cancer, brain disorder/tumor/injury, exposure to organophosphate insecticides, pheochromocytoma, drug/alcohol/substance abuse, Parkinson's disease.This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery or imaging procedures (such as certain X-rays, CT scans) requiring the use of contrast dye (such as metrizamide), tell your doctor or dentist that you are using this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.Children may be more sensitive to the side effects of this drug, especially uncontrolled movements. They may be at greater risk when they are sick (such as having viral infection, dehydration).Older adults may be more sensitive to the side effects of this drug, especially dizziness, lightheadedness, drowsiness, confusion, uncontrollable movements, constipation, difficulty urinating, or blurred vision. Dizziness, lightheadedness, drowsiness, and confusion can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.Since untreated mental/mood problems (such as schizophrenia, psychotic disorders) can be a serious condition, do not stop taking this medication unless directed