Thiothixene is an antipsychotic medicine that is used to treat schizophrenia.

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

You should not use thiothixene if you have a blood cell disorder, or if you have drowsiness, slow breathing, weak pulse, or decreased alertness (such as after drinking alcohol or taking medicines that make you sleepy).

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

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 may not start feeling better right away when you start taking thiothixene. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Schizophrenia:

Mild Conditions:
-Initial dose: 2 mg orally 3 times a day
-Maintenance dose: 15 mg orally per day

Severe Conditions:
-Initial dose: 5 mg orally 2 times a day
-Maintenance dose: 20 to 30 mg orally per day
-Maximum dose: 60 mg orally per day

Comments:
-Dosing should be individually adjusted depending on the chronicity and severity of symptoms.
-In general, small doses should be used initially and gradually increased to the optimal effective level based on patient response.
-Some patients have been successfully maintained on once-a-day therapy.

Use: Schizophrenia

Usual Pediatric Dose for Schizophrenia:

Age 12 years and older:

Mild Conditions:
-Initial dose: 2 mg orally 3 times a day
-Maintenance dose: 15 mg orally per day

Severe Conditions:
-Initial dose: 5 mg orally 2 times a day
-Maintenance dose: 20 to 30 mg orally per day
-Maximum dose: 60 mg orally per day

Comments:
-Dosing should be individually adjusted depending on the chronicity and severity of symptoms.
-In general, small doses should be used initially and gradually increased to the optimal effective level based on patient response.
-Some patients have been successfully maintained on once-a-day therapy.

Use: Schizophrenia

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

• a blood cell disorder such as anemia, low white blood cell counts, or low platelets; or

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

Thiothixene may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• epilepsy or other seizure disorder;

• heart disease;

• low white blood cell (WBC) counts;

• breast cancer; or

• alcoholism.

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 thiothixene. Ask your doctor about any risk.

Thiothixene is not approved for use by anyone younger than 12 years old.

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.

Overdose symptoms may include drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, and fainting.

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 normal diet.

Avoid driving or hazardous activity until you know how thiothixene 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.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Thiothixene can decrease sweating and you may be more prone to heat stroke.

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 thiothixene can cause a serious movement disorder that may not be reversible. The longer you use thiothixene, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

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

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

• stiffness in your neck, tightness in your throat, trouble breathing or swallowing;

• seizure (convulsions);

• a light-headed feeling, like you might pass out;

• severe constipation;

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing; 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 thiothixene may include:

• dry mouth;

• blurred vision;

• nausea, vomiting, diarrhea, constipation;

• fast heartbeats, feeling restless;

• breast swelling or discharge;

• changes in weight or appetite; 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 thiothixene 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.

Other drugs may affect thiothixene, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.