Brand Name(s):

Navane^®

IMPORTANT WARNING

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 thiothixene have an increased chance of death during treatment.

Thiothixene 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 thiothixene. For more information, visit the FDA website:http://www.fda.gov/Drugs

WHY is this medicine prescribed?

Thiothixene 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). Thiothixene is in a group of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

HOW should this medicine be used?

Thiothixene comes as a capsule to take by mouth. It is usually taken one to three times a day. Take thiothixene at around the same time(s) 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 thiothixene 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 thiothixene and gradually increase your dose.

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

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking thiothixene,

tell your doctor and pharmacist if you are allergic to thiothixene, phenothiazines such as chlorpromazine, fluphenazine, perphenazine, prochlorperazine (Compazine), promethazine (Phenergan), thioridazine, and trifluoperazine; or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; atropine (in Motofen, in Lomotil, in Lonox); epinephrine (Epipen); ipratropium (Atrovent); medications for anxiety, high blood pressure, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems; certain medications for seizures such as carbamazepine (Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin); narcotic medications for pain; rifabutin (Mycobutin); rifampin (Rifadin, in Rifamate, in Rifater); 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 what herbal products you are taking, especially St. John's wort.
tell your doctor if you have or have ever had any condition that affects your blood cells. Your doctor may tell you not to take thiothixene.
tell your doctor if you have or have ever had trouble keeping your balance, seizures, breast cancer, or heart disease. Also tell your doctor if you are experiencing alcohol withdrawal (symptoms that a person may experience when he/she suddenly stops drinking alcohol after drinking heavily or for a long time), or if you have ever had to stop taking a medication for mental illness due to severe side effects.
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 thiothixene, call your doctor. Thiothixene. may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking thiothixene.
you should know that this medication may make you drowsy and may affect your thinking and movements, especially at the beginning of your treatment. Do not drive a car or operate machinery until you know how this medication affects you.
ask your doctor about the safe use of alcohol during your treatment with thiothixene. Alcohol can make the side effects of thiothixene worse.
plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Thiothixene may make your skin sensitive to sunlight.
you should know that thiothixene may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
you should know that thiothixene may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking thiothixene. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal 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:

muscle twitching
drowsiness
dizziness
tightness of the neck muscles
uncontrollable movements of a part of the body
excess saliva
difficulty swallowing
difficulty walking
coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Thiothixene may interfere with the results of home pregnancy tests. Talk to your doctor if you think you might be pregnant during your treatment with thiothixene. 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.

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: July 15, 2017.