Pronunciation:

thye-oh-THIX-een

Brand Names:

• Navane

Dosage Forms:

• Capsule

Warnings:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Thiothixene hydrochloride is not approved for the treatment of patients with dementia-related psychosis .

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Thioxanthene

Uses of This Medicine:

Thiothixene is used to treat a mental condition called schizophrenia. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

The use of thiothixene in children younger than 12 years of age is not recommended.

Older adults—

No information is available on the relationship of age to the effects of thiothixene in geriatric patients. However, this medicine should not be used for behavioral problems in older adults with dementia.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bromopride
• Metoclopramide
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Apomorphine
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Dihydrocodeine
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• LetibotulinumtoxinA-wlbg
• Lithium
• Methacholine
• Methadone
• Oliceridine
• Oxycodone
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Sufentanil
• Tapentadol
• Tiotropium
• Tramadol
• Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betel Nut

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., agranulocytosis, leukopenia, neutropenia) or
• Central nervous system depression (severe drowsiness or loss of consciousness) or
• Circulatory collapse (shock-like state)—Should not be used in patients with these conditions.

• Breast cancer, prolactin-dependent or
• Eye or vision problems (e.g., pigmentary retinopathy, lenticular pigmentation) or
• Heart or blood vessel disease or
• Hyperprolactinemia (high prolactin in the blood) or
• Liver disease or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For schizophrenia:
    • Adults and teenagers 12 years of age and older—At first, 2 milligrams (mg) three times per day or 5 mg two times per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children younger than 12 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. You may also need to have your eyes tested on a regular basis while you are using this medicine.

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Stop using this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

Thiothixine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause dizziness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines, including narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

You might get overheated more easily while using this medicine. Be aware of this if you are exercising or the weather is hot. Drinking water might help. If you get too hot and feel dizzy, weak, tired, confused, or sick to your stomach, try to cool down. Call your doctor if you are not able to cool your body and your symptoms continue.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Cough

difficulty with swallowing

dizziness

fast heartbeat

hives

itching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

skin rash

tightness in the chest

unusual tiredness or weakness

wheezing

Incidence not known

Abdominal or stomach pain

back, leg, or stomach pains

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody, black, or tarry stools

blurred vision

chest pain

chills

clay-colored stools

confusion

convulsions

cough or hoarseness

dark urine

difficulty with breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, pounding, or irregular heartbeat or pulse

fever

fever with or without chills

general body swelling

general feeling of tiredness or weakness

headache

high fever

high or low blood pressure

inability to move the eyes

inability to sit still

increased blinking or spasms of the eyelid

increased sweating

lightheadedness

lip smacking or puckering

loss of appetite

loss of balance control

loss of bladder control

lower back or side pain

mask-like face

nausea or vomiting

need to keep moving

nosebleeds

overactive reflexes

painful or difficult urination

pale skin

pinpoint red spots on the skin

puffing of the cheeks

rapid or worm-like movements of the tongue

rapid weight gain

restlessness

seizures

severe muscle stiffness

shuffling walk

slowed movements

slurred speech

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sticking out of the tongue

sweating

swollen glands

tic-like (jerky) movements of the head, face, mouth, and neck

tingling of the hands or feet

tiredness

trembling and shaking of the fingers and hands

trouble with breathing, speaking, or swallowing

uncontrolled chewing movements

uncontrolled movements of the arms and legs

uncontrolled twisting movements of the neck, trunk, arms, or legs

unexplained bleeding or bruising

unpleasant breath odor

unusual bleeding or bruising

unusual facial expressions

unusual weight gain or loss

unusually pale skin

vomiting of blood

yellowing of the eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in consciousness

depression

drowsiness

loss of consciousness

sudden jerky movements of the body

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Absent, missed, or irregular menstrual periods

anxiety

constipation

decreased interest in sexual intercourse

diarrhea

dry mouth

extreme thirst

hives or welts

hyperventilation

inability to have or keep an erection

increased appetite

increased sensitivity of the skin to sunlight

increased sweating

increased thirst

increased weight

irritability

loss in sexual ability, desire, drive, or performance

menstrual changes

nervousness

redness or other discoloration of the skin

severe sunburn

sleeplessness

stopping of menstrual bleeding

stuffy nose

swelling of the breasts or unusual milk production

trouble with sleeping

unable to sleep

watering of mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.