pharmacopeia
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/api/v1/drug/thiothixene

Boxed warning

WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis : Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Thiothixene is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists.

Dopamine

Indications

Sourced from openFDA
  • & USAGE Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.ICD-10: F20.9

Contraindications

Sourced from openFDA
  • Thiothixene capsules are contraindicated in patients with circulatory collapse, comatose states, central nervous system depression due to any cause, and blood dyscrasias. Thiothixene is contraindicated in individuals who have shown hypersensitivity to the drug.contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Dosage of thiothixene capsules should be individually adjusted depending on the chronicity and severity of the symptoms of schizophrenia. 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 thiothixene capsule therapy. The use of thiothixene capsules in children under 12 years of age is not recommended because safe conditions for its use have not been established. In milder conditions, an initial dose of 2 mg three times daily is recommended. If indicated, a subsequent increase to 15 mg/day total daily dose is often effective. In more severe conditions, an initial dose of 5 mg twice daily is recommended. The usual optimal dose is 20 mg to 30 mg daily. If indicated, an increase to 60 mg/day total daily dose is often effective. Exceeding a total daily dose of 60 mg rarely increases the beneficial response.

Warnings & precautions

Sourced from openFDA

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Thiothixene is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs, including thiothixene (1). Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process.

Adverse reactions

Sourced from openFDA

NOTE : Not all of the following adverse reactions have been reported with thiothixene. However, since thiothixene has certain chemical and pharmacologic similarities to the phenothiazines, all of the known side effects and toxicity associated with phenothiazine therapy should be borne in mind when thiothixene is used. Cardiovascular Effects Tachycardia, hypotension, light-headedness, and syncope. In the event hypotension occurs, epinephrine should not be used as a pressor agent since a paradoxical further lowering of blood pressure may result. Nonspecific EKG changes have been observed in some patients receiving thiothixene. These changes are usually reversible and frequently disappear on continued thiothixene therapy. The incidence of these changes is lower than that observed with some phenothiazines. The clinical significance of these changes is not known. CNS Effects Drowsiness, usually mild, may occur although it usually subsides with continuation of thiothixene therapy. The incidence of sedation appears similar to that of the piperazine group of phenothiazines but less than that of certain aliphatic phenothiazines. Restlessness, agitation and insomnia have been noted with thiothixene. Seizures and paradoxical exacerbation of psychotic symptoms have occurred with thiothixene infrequently. Hyperreflexia has been reported in infants delivered from mothers having received structurally related drugs. In addition, phenothiazine derivatives have been associated with cerebral edema and cerebrospinal fluid abnormalities.

Overdosage

Sourced from openFDA

Manifestations include muscular twitching, drowsiness and dizziness. Symptoms of gross overdosage may include CNS depression, rigidity, weakness, torticollis, tremor, salivation, dysphagia, hypotension, disturbances of gait, or coma. Treatment Essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under careful observation and maintain an open airway, since involvement of the extrapyramidal system may produce dysphagia and respiratory difficulty in severe overdosage. If hypotension occurs, the standard measures for managing circulatory shock should be used (I.V. fluids and/or vasoconstrictors). If a vasoconstrictor is needed, norepinephrine and phenylephrine are the most suitable drugs. Other pressor agents, including epinephrine, are not recommended, since phenothiazine derivatives may reverse the usual pressor action of these agents and cause further lowering of blood pressure. If CNS depression is marked, symptomatic treatment is indicated. Extrapyramidal symptoms may be treated with antiparkinson drugs. There are no data on the use of peritoneal or hemodialysis, but they are known to be of little value in phenothiazine intoxication.

Approval history

Sourced from openFDA
  • Apr 5, 2019ANDAANDA211642Novitium Pharma
  • Feb 28, 2022ANDAANDA215456Amneal

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
218 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diabetes Mellitus2511%
  2. 2Drug Ineffective167.3%
  3. 3Weight Increased167.3%
  4. 4Depression156.9%
  5. 5Fatigue146.4%
  6. 6Nausea136.0%
  7. 7Dizziness125.5%
  8. 8Type 2 Diabetes Mellitus115.0%
  9. 9Obesity104.6%
  10. 10Pancreatitis104.6%
  11. 11Tardive Dyskinesia104.6%
  12. 12Tremor104.6%
  13. 13Anxiety94.1%
  14. 14Condition Aggravated94.1%
  15. 15Constipation83.7%

Literature

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Recent PubMed references pinned to Thiothixene as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Thiothixene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Thiothixene work?
Mechanism-of-action classes: Adrenergic alpha-Antagonists; Dopamine Antagonists.
What is Thiothixene used for?
According to FDA labeling, Thiothixene carries indications including: & USAGE Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Thiothixene?
Thiothixene is classified as Thioxanthene derivatives, Typical Antipsychotic, Adrenergic alpha-Antagonists, Dopamine Antagonists, Decreased Central Nervous System Organized Electrical Activity, Decreased Dopamine Activity, Decreased Norepinephrine Activity.
What are the contraindications for Thiothixene?
Thiothixene labeling lists contraindications including: Thiothixene capsules are contraindicated in patients with circulatory collapse, comatose states, central nervous system depression due to any cause, and blood dyscrasias. Thiothixene is contraindicated in individuals who have shown hypersensitivity to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for thiothixene is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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