should be sought; the need for continued treatment should be reassessed periodically If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered; however, some patients may require treatment despite the presence of the syndrome Neuroleptic malignant syndrome A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic drugs, including thiothixene(2); clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias) Diagnostic evaluation of patients with this syndrome is complicated; in arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (eg, pneumonia, systemic infection, etc) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS) Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology; the management of NMS should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment, and medical monitoring, and treatment of any concomitant serious medical problems for which specific treatments are available There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS; if a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered; the patient should be carefully monitored since recurrences of NMS have been reported Pregnancy Safe use during pregnancy not established; drug should be given to pregnant patients only when, in the judgment of the physician, the expected benefits from treatment exceed possible risks to mother and fetus Animal data Animal reproduction studies and clinical experience to date have not demonstrated any teratogenic effects; in animal reproduction studies, there was some decrease in conception rate and litter size, and an increase in resorption rate in rats and rabbits Similar findings reported with other psychotropic agents; after repeated oral administration to rats (5 to 15 mg/kg/day), rabbits (3 to 50 mg/kg/day), and monkeys (1 to 3 mg/kg/day) before and during gestation, no teratogenic effects were seen Lactation Not known if drug excreted in breast milk; other agents preferred in nursing mothersPregnancy 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 Thioxanthene; dopamine D2 receptor antagonist; may also have anticholinergic and alpha-blocking effects Pharmacokinetics Half-life elimination: 24 hr Metabolism: Liver (CYP1A2) Protein bound: 90% BRAND FORM. UNIT PRICE PILL IMAGE thiothixene oral- 5 mg capsulethiothixene oral- 2 mg capsulethiothixene oral- 1 mg capsulethiothixene oral- 10 mg capsulethiothixene oral- 5 mg capsulethiothixene oral- 2 mg capsulethiothixene oral- 10 mg capsulethiothixene oral- 1 mg capsulethiothixene oral- 1 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationthiothixene oral THIOTHIXENE - ORAL (thigh-oh-THICKS-een) COMMON BRAND NAME(S): Navane 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: Thiothixene is used to treat certain mental/mood disorders (such as schizophrenia). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggression and the desire to hurt yourself/others. It may also help to decrease hallucinations (such as hearing/seeing things that are not there). Thiothixene is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances (such as dopamine) in the brain. HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 1 to 3 times daily.Dosage is based on your age, medical condition, and response to treatment. To reduce your risk of side effects such as drowsiness and shaking (tremor), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's directions carefully.Take this medication regularly in order 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, for some conditions 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 severe confusion and hallucinations. 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: See also Warning section.Drowsiness, dizziness, lightheadedness, dry mouth, blurred vision, constipation, 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: stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), restlessness/constant need to move, shaking (tremor), slow/shuffling walk, drooling/trouble swallowing, 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: fainting, confusion, depression/suicidal thoughts, difficulty urinating, easy bruising/bleeding, signs of infection (such as sore throat that doesn't go away, fever), severe stomach/abdominal pain, seizures.This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any involuntary/repetitive muscle movements such as lip smacking/puckering, tongue thrusting, chewing, or finger/toe movements.In rare cases, thiothixene 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.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: See also Warning section.Before taking this medication, tell your doctor or pharmacist if you are allergic to it; 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: blood problems (such as low red/white/platelet blood cell counts), a certain eye condition (glaucoma), heart problems (such as fast/irregular heartbeat, low blood pressure), liver disease, breast cancer, brain disorder/tumor/injury, drug/alcohol/substance abuse, Parkinson's disease, seizures, a certain severe reaction to other antipsychotic-type medications (neuroleptic malignant syndrome-NMS), slow movement of the gut/intestines (such as chronic constipation, intestinal blockage), difficulty urinating (such as due to prostate problems).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).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.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 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.Older adults may be more sensitive to the side effects of this drug, especially dizziness, lightheadedness, drowsiness, confusion, constipation, trouble urinating, extrapyramidal symptoms (EPS), and tardive dyskinesia (TD) (see Side Effects). 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) 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.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: 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), lithium, drugs that increase the amount of dopamine in your body (such as cabergoline, levodopa, pergolide, ropinirole), drugs that lower blood pressure (such as guanethidine, alpha blockers like prazosin).Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid 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. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or