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.Who should not take Stelazine?
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.
Take this medication by mouth with or without food, usually once or twice daily or as directed by your doctor.
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.
Drowsiness, dizziness, dry mouth, blurred vision, tiredness, constipation, weight gain, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, 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 your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: difficulty urinating, sunburn-like rash (sun sensitivity), 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.
Infrequently, 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 seek immediate medical attention, or permanent problems could occur.
Tell your doctor right away if any of these rare but serious side effects occur: signs of liver problems (such as yellowing eyes/skin, persistent nausea, vomiting, stomach/abdominal pain), signs of infection (such as fever, persistent sore throat), 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).
Seek immediate medical attention if any of these rare but serious side effects occur: 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, seek immediate medical attention 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.
See also Warning section.
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.
This medication should not be used in people who are intoxicated with alcohol/narcotics/other drugs that cause drowsiness/slowed breathing.
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, loss of too much body water (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 cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
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. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
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 with acute illnesses (such as a viral infection, dehydration) are at increased risk for serious muscle problems during trifluoperazine treatment. Consult the doctor for more details.
Older adults may be more sensitive to the side effects of this drug, especially dizziness (more likely when standing up), drowsiness, confusion, uncontrollable movements, constipation, difficulty urinating, or blurred vision. Dizziness, 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 by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: anticholinergic/antispasmodic drugs (such as atropine, dicyclomine, scopolamine), drugs that increase the amount of dopamine in your body (such as cabergoline, levodopa, pergolide, ropinirole), guanethidine, lithium, phenytoin, propranolol, warfarin, other drugs that cause dizziness upon standing (including alpha blockers such as prazosin, diuretics/"water pills" such as hydrochlorothiazide).
Tell your doctor or pharmacist if you are taking other products that cause drowsiness or may slow your breathing including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Also report the use of drugs that might increase seizure risk when combined with trifluoperazine, such as isoniazid (INH), theophylline, tramadol, or tricyclic antidepressants (such as amitriptyline), among others. Consult your doctor or pharmacist for details.
This medication may interfere with certain laboratory tests (such as phenylketonuria tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/deep sleep, loss of consciousness, agitation, restlessness, seizures, irregular heartbeat.
Do not share this medication with others.
Laboratory and/or medical tests (such as liver tests, blood counts, eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all medical and laboratory appointments.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2016. Copyright(c) 2016 First Databank, Inc.
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