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Thiothixene

Pronunciation: (THYE-oh-THIX-een)
Class: Thioxanthene derivative

Trade Names:
Navane
- Capsules 2 mg
- Capsules 5 mg
- Capsules 10 mg
- Capsules 20 mg

Trade Names:
Thiothixene
- Capsules 1 mg

Pharmacology

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Produces antipsychotic effects, apparently because of dopamine-receptor blocking in CNS.

Indications and Usage

Management of schizophrenia.

Contraindications

Circulatory collapse; comatose states; CNS depression due to any cause; blood dyscrasias; hypersensitivity to any component of the product.

Dosage and Administration

Mild Conditions
Adults and Children 12 yr of age and older

PO Start with 2 mg 3 times daily; an increase to 15 mg/day is often effective if needed.

Severe Conditions
Adults and Children 12 yr of age and older

PO Start with 5 mg twice daily. The usual optimal dosage is 20 to 30 mg/day. If indicated, an increase to 60 mg/day may be effective. Dosages above 60 mg/day rarely increase the beneficial response.

Storage/Stability

Store at 68° to 77°F. Protect from moisture. Protect from light.

Drug Interactions

Alcohol, other CNS depressants

May cause additive CNS depressant effects.

Anticholinergics

May reduce therapeutic effects and increase anticholinergic effects of thiothixene; may lead to tardive dyskinesia.

Guanethidine

May inhibit hypotensive effect of guanethidine.

Hepatic microsomal enzyme–inducing agents (eg, carbamazepine)

Thiothixene plasma concentrations may be reduced, decreasing the efficacy.

Hypotensive agents

Excessive hypotension may result from additive effects.

Laboratory Test Interactions

False-positive pregnancy test results may occur.

Adverse Reactions

Cardiovascular

Hypotension, light-headedness, nonspecific ECG changes, syncope, tachycardia.

CNS

Agitation; cerebral edema; cerebrospinal fluid abnormalities; drowsiness; extrapyramidal symptoms including akathisia, dystonia, and pseudo-parkinsonism; fatigue/weakness; insomnia; paradoxical exacerbation of psychotic symptoms; restlessness; sedation; seizures; tardive dyskinesia.

Dermatologic

Increased sweating, photosensitivity, pruritus, rash, urticaria.

EENT

Blurred vision, nasal congestion.

GI

Anorexia, constipation, diarrhea, dry mouth, increased appetite, increased salivation, nausea, vomiting.

Endocrine

Hyperprolactinemia.

Genitourinary

Amenorrhea, breast enlargement, impotence, lactation, menstrual irregularities.

Hematologic-Lymphatic

Leukocytosis; leukopenia.

Hepatic

Elevated alkaline phosphatase, elevated serum transaminases.

Metabolic-Nutritional

Increased weight, peripheral edema.

Miscellaneous

Anaphylaxis, hyperpyrexia, NMS, polydipsia.

Precautions

Warnings

Increased mortality

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with taking placebo. Over the course of a 10-wk controlled trial, the rate of death in drug-treated patients was about 4.5% compared with 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either CV (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.

Monitor

Patients requiring antipsychotic drug treatment after recovery from NMS should be monitored for recurrence of NMS if thiothixene therapy is reintroduced.

Pregnancy

Pregnancy category undetermined.

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Special Risk Patients

Use drug with caution in patients with CV disease, seizure disorders, or those exposed to extreme heat.

Blood dyscrasias

Agranulocytosis, pancytopenia, and thrombocytopenic purpura have been reported with related drugs.

CNS effects

Drug may impair mental or physical abilities, especially during first few days of therapy.

NMS

NMS has occurred with similar agents and is potentially fatal. Signs and symptoms are hyperpyrexia, muscle rigidity, altered mental status, irregular pulse, irregular BP, tachycardia, and diaphoresis.

Tardive dyskinesia

Potentially irreversible involuntary body and facial movements may occur. Prevalence highest in elderly, especially women.

Overdosage

Symptoms

CNS depression, coma, disturbances of gait, dizziness, drowsiness, dysphagia, hypotension, muscular twitching, rigidity, salivation, torticollis, tremor, weakness.

Patient Information

Advise patient, family, or caregiver that dose will be adjusted periodically until max benefit has been obtained.
Instruct patient not to stop taking thiothixene when feeling better.
Instruct patient, family, or caregiver to immediately report fainting, dizziness, high fever, muscle rigidity, altered mental status, and irregular pulse.
Advise patient, family, or caregiver to notify health care provider of the following: excessive drowsiness, increased agitation or anxiety, involuntary body or facial movements.
Advise patient to avoid strenuous activity during periods of high temperature or humidity.
Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
Instruct patient to get up slowly from lying or sitting position and to avoid sudden position changes to prevent postural hypotension. Advise patient to report dizziness with position changes to health care provider. Caution patient that hot tubs and hot showers or baths may worsen dizziness.
Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
Advise patient that drug may cause drowsiness or impaired judgment or thinking skills and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
Caution patient that medication may cause sensitivity to sunlight and to avoid unnecessary exposure to UV light (eg, sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light until tolerance is determined.