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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
TRIFLUOPERAZINE TABLET - ORAL
WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as pneumonia, heart failure) when this medication is used in 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, 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 immediately. Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: 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 immediately 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 immediately 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/muscle pain, skin discoloration, eye/vision changes, feeling unusually cold or hot, muscle weakness. Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor immediately 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 immediately. 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 immediately if any of these rare but serious side effects occur: signs of liver problems (such as yellowing eyes/skin, dark urine, 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 drug may rarely cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome-NMS). Seek immediate medical attention if you notice any of the following side effects: fever, stiff muscles, increased sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness), 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. 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: 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 a patient who is unconscious or 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 decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Seek immediate medical attention if you develop a fever, 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, drowsiness, uncontrollable movements, and anticholinergic effects (such as constipation, difficulty urinating, and blurred vision). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away. This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using 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, 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 bupropion, 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. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline 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.
NOTES: 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.
MISSED DOSE: 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.
STORAGE: 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 February 2012. Copyright(c) 2012 First Databank, Inc.