Thiothixene

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

Thiothixene is a prescription medication used to treat schizophrenia. Thiothixene belongs to a group of drugs called antipsychotics, which work by altering the activity of certain natural substances in the brain.

This medication comes in capsule form and is typically taken 1 to 3 times a day, with or without food.

Common side effects of thiothixene include uncontrolled muscle movement, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how thiothixene affects you.

Thiothixene is not approved for use in psychotic conditions related to dementia. Thiothixene may increase the risk of death in older adults with dementia-related conditions.

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).

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 is not approved for use in psychotic conditions related to dementia. Thiothixene may increase the risk of death in older adults with dementia-related conditions.

Long-term use of thiothixene can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take thiothixene, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.

To make sure thiothixene is safe for you, tell your doctor if you have:

• epilepsy or other seizure disorder;

• heart disease;

• a history of low white blood cell (WBC) counts;

• a history of breast cancer; or

• if you are addicted to alcohol.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking thiothixene, do not stop taking it without your doctor's advice.

It is not known whether thiothixene passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Thiothixene should not be given to a child younger than 12 years old.

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

General

• Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.101 b c u

• Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.101 b u w (See Tardive Dyskinesia under Cautions.)

• For symptomatic relief of psychotic disorders, initial therapeutic response to antipsychotic therapy usually occurs within 2–4 weeks and optimum therapeutic response occurs within 6 months or longer.100 w

Administration

Oral Administration

Thiothixene is administered orally once daily or in divided doses 2 or 3 times daily.101 b c k t u Thiothixene hydrochloride has been given orally and parenterally, but no longer is commercially available in the US.101 c h v

Dosage

Pediatric Patients

Children ≥12 years of age: Initially, 2 mg 3 times daily for mild to moderate psychotic disorders; may gradually increase dosage, if necessary, up to 15 mg daily.101 b c u

For more severe psychotic disorders in children ≥12 years of age: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.101 b c u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.101 b c k u

Daily dosages >60 mg rarely provide additional therapeutic effect.101 b c u

Adults

For mild to moderate psychotic disorders: Initially, 2 mg 3 times daily; may gradually increase dosage, if necessary, up to 15 mg daily.101 b c u

For more severe psychotic disorders: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.101 b c u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.101 b c k u

Daily dosages >60 mg rarely provide additional therapeutic effect.101 b c u

Prescribing Limits

Pediatric Patients

Children ≥12 years of age: Maximum 60 mg daily.101 b c u

Adults

Maximum 60 mg daily.101 b c u

Special Populations

Geriatric Patients

No specific dosage recommendations for geriatric patients, but generally select dosage at the lower end of recommended range; increase dosage more gradually and monitor closely.100 101 b h u w (See Geriatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

• It is used to treat schizophrenia.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Weight gain.
• Not hungry.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• More hungry.
• Feeling sleepy.
• Not able to sleep.
• Feeling tired or weak.
• More thirst.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

No dosage adjustment provided in manufacturer’s labeling.

Applies to thiothixene: intramuscular powder for injection, oral capsule, oral concentrate

Nervous system

Frequency not reported: Tardive dyskinesia, extrapyramidal symptoms (e.g., pseudoparkinsonism, akathisia, dystonia), drowsiness, sedation, restlessness, agitation, insomnia, seizures, paradoxical exacerbation of psychotic symptoms[Ref]

Endocrine

Frequency not reported: Hyperprolactinemia, lactation, menstrual irregularities, moderate breast enlargement, galactorrhea, amenorrhea, gynecomastia, impotence[Ref]

Cardiovascular

Frequency not reported: Tachycardia, hypotension, lightheadedness, syncope, nonspecific ECG changes[Ref]

General

-As this drug has certain chemical and pharmacological similarities to the phenothiazines, all the side effects and toxicity associated with phenothiazines should be considered when this drug is used.
-Side effects of phenothiazines (not reported in this drug) include: cerebral edema, cerebrospinal fluid abnormalities, liver damage (jaundice, biliary stasis), eosinophilia, hemolytic anemia, pancytopenia, thrombocytopenic purpura, neutropenia, agranulocytosis, hyperreflexia (in infants whose mothers received phenothiazines), hypoglycemia, hyperglycemia, glycosuria, exfoliative dermatitis, contact dermatitis (in nursing personnel), miosis, mydriasis, adynamic ileus, and systemic lupus erythematosus-like syndrome.[Ref]

Immunologic

Rare (less than 0.1%): Anaphylaxis
Frequency not reported: Allergic reactions (rash, pruritus, urticaria, photosensitivity)[Ref]

Hematologic

Frequency not reported: Leukopenia and leukocytosis (usually transient)[Ref]

Hepatic

Frequency not reported: Elevated serum transaminase and elevated alkaline phosphatase (usually transient)[Ref]

Metabolic

Frequency not reported: Anorexia, increased appetite, increased weight, polydipsia[Ref]

Other

Frequency not reported: Hyperpyrexia, weakness/fatigue, peripheral edema[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, constipation, increased salivation[Ref]

Ocular

Frequency not reported: Blurred vision[Ref]

Dermatologic

Frequency not reported: Increased sweating[Ref]

Respiratory

Frequency not reported: Nasal congestion[Ref]

Some side effects of thiothixene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.