Brand Name(s):

Mellaril^® ¶

IMPORTANT WARNING

For all patients:

Thioridazine can cause a serious type of irregular heartbeat that may cause sudden death. There are other medications that can be used to treat your condition that are less likely to cause this life-threatening side effect. Therefore, you should not take thioridazine unless you have already been treated with at least 2 other medications for your condition and these medications did not work well or caused side effects that you could not tolerate.

Tell your doctor if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death), a slow or irregular heartbeat, high or low blood pressure, heart disease, or a low level of potassium in your blood. Also tell your doctor if you are taking or plan to take any of the following medications: amiodarone (Cordarone), cisapride (Propulsid) (not available in the US), disopyramide (Norpace), dofetilide (Tikosyn), erythromycin (E.E.S., E-Mycin, Erythrocin), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), moxifloxacin (Avelox), paroxetine (Paxil, Pexeva), pimozide (Orap), pindolol (Visken), procainamide, propranolol (Inderal), quinidine, sotalol (Betapace, Betapace AF), and sparfloxacin (Zagam) (not available in the US). Your doctor will probably tell you not to take thioridazine if you are taking any of these medications or if you have any of these conditions.

In addition to the medications listed above, there are other medications that may increase the risk that thioridazine will cause you to develop a serious irregular heartbeat. Before you begin to take any new medication, tell the doctor who is prescribing the medication that you are taking thioridazine.

If you experience any of the following symptoms, call your doctor immediately: fast, irregular, or pounding heartbeat; dizziness; lightheadedness; or fainting.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests and electrocardiograms (tests to measure the electrical activity of the heart) before and during your treatment with thioridazine, especially when your dose is changed.

Talk to your doctor about the risks of taking thioridazine.

For older adults:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as thioridazine have an increased chance of death during treatment.

Thioridazine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking thioridazine. For more information, visit the FDA website:http://www.fda.gov/Drugs

WHY is this medicine prescribed?

Thioridazine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in people who have already been treated with at least 2 other medications and have not been helped or who have experienced severe side effects. Thioridazine is in a group of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

HOW should this medicine be used?

Thioridazine comes as a tablet to take by mouth. It is usually taken two to four times a day. Take thioridazine at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take thioridazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of thioridazine and gradually increase your dose until your symptoms are controlled. Once your symptoms have been controlled for some time, your doctor may decrease your dose. Be sure to tell your doctor how you are feeling during your treatment with thioridazine.

Thioridazine may help to control your symptoms but will not cure your condition. Continue to take thioridazine even if you feel well. Do not stop taking thioridazine without talking to your doctor.

Are there OTHER USES for this medicine?

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking thioridazine,

tell your doctor and pharmacist if you are allergic to thioridazine, other phenothiazines such as chlorpromazine, fluphenazine, perphenazine, prochlorperazine (Compro), promethazine (Phenergan), or trifluoperazine; or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section or any of the following: antidepressants; antihistamines; atropine (in Motofen, in Lomotil, in Lonox); barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal); epinephrine (Epipen); ipratropium (Atrovent); medications for anxiety or mental illness, irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; narcotic medications for pain; sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you are thinking about killing yourself or planning or trying to do so and if you have or have ever had any of the conditions listed in the IMPORTANT WARNING section or either of the following: seizures or breast cancer. Also tell your doctor if you have ever had to stop taking a medication for mental illness due to severe side effects or if you plan to work with organophosphorus insecticides (a type of chemical used to kill insects).
tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking thioridazine, call your doctor. Thioridazine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
talk to your doctor about the risks and benefits of taking thioridazine if you are 65 years of age or older. Older adults should not usually take thioridazine because it is not as safe as other medications that can be used to treat the same condition.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking thioridazine.
you should know that this medication may make you drowsy and may affect your thinking and movements. Tell your doctor if you plan to drive a car or operate machinery. Your doctor will tell you if these activities are safe for you and may increase the dose of your medication very gradually so that your body can adjust to these side effects.
ask your doctor about the safe use of alcohol while you are taking thioridazine. Alcohol can make the side effects of thioridazine worse.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

slow, fast, or irregular heartbeat
drowsiness
slowed or unusual movements
confusion
agitation
high or low body temperature
seizures
restlessness
coma (loss of consciousness for a period of time)
widened or narrowed pupils (black circles in the middle of the eyes)
dry mouth
stuffed nose
difficulty urinating
blurred vision
slowed breathing
constipation

What OTHER INFORMATION should I know?

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.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2017.