Thioridazine is a phenothiazine (FEEN-oh-THYE-a-zeen) antipsychotic medicine that is used to treat schizophrenia.

Thioridazine is usually given after other treatments have failed.

Thioridazine may also be used for purposes not listed in this medication guide.

You should not use thioridazine if you have a heart rhythm disorder, a history of long QT syndrome, untreated or uncontrolled high blood pressure, very low blood pressure, or if you have drowsiness, slow breathing, weak pulse, or decreased alertness.

Thioridazine is not approved for use in older adults with dementia-related psychosis.

Thioridazine can cause a serious heart problem, especially if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV. Tell your doctor about all your current medicines and any you start or stop using.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

If you need surgery, tell the surgeon ahead of time that you are using thioridazine.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Schizophrenia:

Initial dose: 50 to 100 mg orally 3 times a day
Maintenance dose: 200 to 800 mg/day, divided into 2 to 4 doses
Maximum dose: 800 mg/day

Comment: Once control is attained, the dose should be gradually lowered to determine the minimum effective maintenance dose.

Use: Patients with schizophrenia who have failed to respond to treatment with at least 2 other antipsychotic agents due to insufficient effectiveness or inability to achieve an effective dose due to intolerable side effects

Usual Pediatric Dose for Schizophrenia:

Initial dose: 0.5 mg/kg/day orally, in divided doses
Maximum dose: 3 mg/kg/day, in divided doses

Comment: The dose should be increased gradually until therapeutic effects are observed and/or the maximum dose is reached.

Use: Patients with schizophrenia who have failed to respond to treatment with at least 2 other antipsychotic agents due to insufficient effectiveness or inability to achieve an effective dose due to intolerable side effects

You should not use thioridazine if you are allergic to it, or if you have:

• heart problems;

• long QT syndrome (in you or a family member);

• untreated or uncontrolled high blood pressure;

• very low blood pressure; or

• if you have drowsiness, slow breathing, weak pulse, or decreased alertness (such as after drinking alcohol or taking medicines that make you sleepy).

Thioridazine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines. Your doctor may change your treatment plan if you also use:

• antibiotics;

• antidepressants;

• blood pressure medicine;

• cancer medicine;

• certain HIV/AIDS medicines;

• heart rhythm medicine;

• medicine to treat or prevent malaria; or

• other antipsychotic medicines.

Tell your doctor if you have ever had:

• heart problems, high blood pressure;

• slow heartbeats that have caused you to faint;

• breast cancer;

• liver or kidney disease;

• seizures;

• Parkinson's disease;

• enlarged prostate or urination problems;

• low levels of potassium in your blood (hypokalemia); or

• a serious side effect while using thioridazine or another phenothiazine.

Tell your doctor if you are pregnant or if you become pregnant. Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

It may not be safe to breastfeed while using thioridazine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your usual diet.

Avoid driving or hazardous activity until you know how thioridazine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid drinking alcohol. Dangerous side effects could occur.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of thioridazine can cause a serious movement disorder that may not be reversible. The longer you use thioridazine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Thioridazine may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your arms, legs, or face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• agitation, confusion;

• seizure (convulsions);

• decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;

• little or no urinating;

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of thioridazine may include:

• drowsiness;

• dry mouth, blurred vision;

• nausea, vomiting, constipation, diarrhea;

• breast swelling or discharge;

• changes in your menstrual periods; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking thioridazine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect thioridazine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Thioridazine may interfere with the results of home pregnancy tests. Talk to your doctor if you think you might be pregnant during your treatment with thioridazine. Do not try to test for pregnancy at home.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.