View source for Thiothixene

{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|genericName=Thiothixene
|aOrAn=a
|drugClass=antipsychotic, central nervous system agent and thioxanthene
|indicationType=treatment
|indication=[[schizophrenia]]
|hasBlackBoxWarning=Yes
|adverseReactions=[[hypotension]], [[orthostatic hypotension]], diminished sweating, [[constipation]], [[xerostomia]], [[akathisia]], [[dizziness]], [[tardive dystonia]], [[dystonia]], [[extrapyramidal]] disease, [[parkinsonian]], [[somnolence]], [[tardive dyskinesia]], [[blurred vision]], [[urinary retention]] and [[nasal congestion]]
|blackBoxWarningTitle=WARNING
|blackBoxWarningBody=* 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.

<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=* 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]].

====Dosing Information====

* 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.

* 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.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.

<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.

<!--Pediatric Indications and Dosage-->

<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=* Thiothixene capsules are effective in the management of [[schizophrenia]] for children 12 years and older.

* 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.

====Dosing Information====
=====Dosage=====
* Initial dose of 2 mg X 3/day and then increase to 20/day to 30 mg/day with a maximum of 60 mg/day.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.

<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.

<!--Contraindications-->
|contraindications=* 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. It is not known whether there is a cross sensitivity between the thioxanthenes and the [[phenothiazine]] derivatives, but this possibility should be considered.
|warnings======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]].

=====[[Tardive Dyskinesia]]=====

* [[Tardive dyskinesia]], a syndrome consisting of potentially irreversible, involuntary, [[dyskinetic]] movements may develop in patients treated with [[antipsychotic]] drugs, including thiothixene. 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. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

* Given these considerations, [[antipsychotics]] should be prescribed in a manner that is most likely to minimize the occurrence of [[tardive dyskinesia]]. Chronic [[antipsychotic]] treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to [[antipsychotic]] drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

* If signs and symptoms of [[tardive dyskinesia]] appear in a patient on [[antipsychotics]], drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

(For further information about the description of [[tardive dyskinesia]] and its clinical detection, please refer to INFORMATION FOR PATIENTS IN THE PRECAUTIONS section, and to the ADVERSE REACTIONS section.)

=====[[Neuroleptic Malignant Syndrome]] (NMS)=====

* A potentially fatal symptom complex sometimes referred to as [[Neuroleptic Malignant Syndrome]] (NMS) has been reported in association with [[antipsychotic]] drugs, including thiothixene. Clinical manifestations of NMS are [[hyperpyrexia]], muscle rigidity, altered mental status and evidence of autonomic instability ([[irregular pulse]] or blood pressure, [[tachycardia]], [[diaphoresis]], and [[cardiac dysrhythmias]]).

* The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., [[pneumonia]], systemic [[infection]], etc.) and untreated or inadequately treated [[extrapyramidal]] signs and symptoms ([[EPS]]). Other important considerations in the differential diagnosis include central [[anticholinergic]] toxicity, [[heat stroke,]] [[drug fever]] and primary [[central nervous system]] ([[CNS]]) [[pathology]].

* The management of NMS should include 1) immediate discontinuation of [[antipsychotic]] drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

* If a patient requires [[antipsychotic]] drug treatment after recovery from [[NMS]], the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of [[NMS]] have been reported.

=====Usage in Pregnancy=====

* Safe use of thiothixene during pregnancy has not been established. Therefore, this drug should be given to pregnant patients only when, in the judgment of the physician, the expected benefits from the treatment exceed the possible risks to mother and fetus. Animal reproduction studies and clinical experience to date have not demonstrated any teratogenic effects.

* In the animal reproduction studies with thiothixene, there was some decrease in conception rate and litter size, and an increase in resorption rate in rats and rabbits. Similar findings have been reported with other psychotropic agents. After repeated oral administration of thiothixene to rats (5 to 15 mg/kg/day), rabbits (3 to 50 mg/kg/day), and monkeys (1 to 3 mg/kg/day) before and during gestation, no [[teratogenic]] effects were seen.

=====Usage in Children=====

* The use of thiothixene in children under 12 years of age is not recommended because safe conditions for its use have not been established.

* As is true with many CNS drugs, thiothixene may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, especially during the first few days of therapy. Therefore, the patient should be cautioned accordingly.

* As in the case of other CNS-acting drugs, patients receiving thiothixene should be cautioned about the possible additive effects (which may include [[hypotension]]) with [[CNS depressants]] and with [[alcohol]].

====PRECAUTIONS====

* An [[antiemetic]] effect was observed in animal studies with thiothixene; since this effect may also occur in man, it is possible that thiothixene may mask signs of overdosage of toxic drugs and may obscure conditions such as [[intestinal obstruction]] and [[brain tumor]].

* In consideration of the known capability of thiothixene and certain other [[psychotropic]] drugs to precipitate convulsions, extreme caution should be used in patients with a history of [[convulsive]] disorders or those in a state of alcohol withdrawal, since it may lower the convulsive threshold. Although thiothixene potentiates the actions of the barbiturates, the dosage of the [[anticonvulsant therapy]] should not be reduced when thiothixene is administered concurrently.

* Though exhibiting rather weak [[anticholinergic]] properties, thiothixene should be used with caution in patients who might be exposed to extreme heat or who are receiving [[atropine]] or related drugs.

* Use with caution in patients with cardiovascular disease.

* Caution as well as careful adjustment of the dosages is indicated when thiothixene is used in conjunction with other [[CNS depressants]].

* Also, careful observation should be made for [[pigmentary retinopathy]] and [[lenticular pigmentation]] (fine [[lenticular pigmentation]] has been noted in a small number of patients treated with thiothixene for prolonged periods). [[Blood dyscrasias]] ([[agranulocytosis]], [[pancytopenia]], [[thrombocytopenic purpura]]), and [[liver damage]] ([[jaundice]], [[biliary stasis]]), have been reported with related drugs.

* [[Antipsychotic]] drugs, including thiothixene3, elevate [[prolactin]] levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human [[breast cancers]] are [[prolactin]] dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as [[galactorrhea]], [[amenorrhea]], [[gynecomastia]], and [[impotence]] have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of [[antipsychotic]] drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary [[tumorigenesis]]; the available evidence is considered too limited to be conclusive at this time.

====[[Leukopenia]], [[Neutropenia]] and [[Agranulocytosis]]====
=====Class Effect=====

* In clinical trial and/or post-marketing experience, events of [[leukopenia]]/[[neutropenia]] and [[agranulocytosis]] have been reported temporally related to [[antipsychotic]] agents.

* Possible risk factors for [[leukopenia]]/[[neutropenia]] include preexisting low white blood cell count ([[WBC]]) and history of drug induced [[leukopenia]]/[[neutropenia]]. Patients with a history of a clinically significant low WBC or drug induced [[leukopenia]]/[[neutropenia]] should have their [[complete blood count]] ([[CBC]]) monitored frequently during the first few months of therapy and discontinuation of thiothixene should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

* Patients with clinically significant [[neutropenia]] should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe [[neutropenia]] ([[absolute neutrophil count]] < 1000/mm3) should discontinue thiothixene and have their WBC followed until recovery.
|clinicalTrials=* 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.

=====[[Extrapyramidal]] Symptoms=====

* [[Extrapyramidal]] symptoms, such as [[pseudoparkinsonism]], [[akathisia]] and [[dystonia]] have been reported. Management of these [[extrapyramidal]] symptoms depends upon the type and severity. Rapid relief of acute symptoms may require the use of an injectable [[antiparkinson agent]]. More slowly emerging symptoms may be managed by reducing the dosage of thiothixene and/or administering an oral [[antiparkinson agent]].

=====[[Dystonia]]=====

=====Class Effect=====

* Symptoms of [[dystonia]], prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. [[Dystonic]] symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, [[swallowing]] difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation [[antipsychotic]] drugs. An elevated risk of acute [[dystonia]] is observed in males and younger age groups.

=====Persistent [[Tardive Dyskinesia]]=====

* As with all [[antipsychotic]] agents, [[tardive dyskinesia]] may appear in some patients on long-term therapy with thiothixene, or may occur after drug therapy has been discontinued. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.

* Since early detection of [[tardive dyskinesia]] is important, patients should be monitored on an ongoing basis. It has been reported that fine vermicular movement of the tongue may be an early sign of the syndrome. If this or any other presentation of the syndrome is observed, the clinician should consider possible discontinuation of [[antipsychotic]] medication.

=====Hepatic Effects=====

* Elevations of serum transaminase and alkaline phosphatase, usually transient, have been infrequently observed in some patients. No clinically confirmed cases of jaundice attributable to thiothixene have been reported.

=====[[Hematologic]] Effects=====

* As is true with certain other psychotropic drugs, [[leukopenia]] and [[leucocytosis]], which are usually transient, can occur occasionally with thiothixene. Other [[antipsychotic]] drugs have been associated with [[agranulocytosis]], [[eosinophilia]], [[hemolytic anemia]], [[thrombocytopenia]] and [[pancytopenia]].

=====[[Allergic]] Reactions=====

* [[Rash]], [[pruritus]], [[urticaria]], [[photosensitivity]] and rare cases of [[anaphylaxis]] have been reported with thiothixene. Undue exposure to sunlight should be avoided. Although not experienced with thiothixene, [[exfoliative dermatitis]] and contact dermatitis (in nursing personnel) have been reported with certain [[phenothiazines]].

=====[[Endocrine]]/[[Reproductive]]=====

* [[Hyperprolactinemia3]],  [[lactation]], [[menstrual]] irregularities, moderate [[breast]] enlargement and [[amenorrhea]] have occurred in a small percentage of females receiving thiothixene. If persistent, this may necessitate a reduction in dosage or the discontinuation of therapy. [[Phenothiazines]] have been associated with false positive [[pregnancy]] tests, [[gynecomastia]], [[hypoglycemia]], [[hyperglycemia]] and [[glycosuria]].

=====[[Autonomic]] Effects=====

* Dry mouth, [[blurred vision]], [[nasal congestion]], [[constipation]], increased [[sweating]], increased [[salivation]] and [[impotence]] have occurred infrequently with thiothixene therapy. Phenothiazines have been associated with miosis, mydriasis, and adynamic ileus.

=====Other Adverse Reactions=====

* [[Hyperpyrexia]], [[anorexia]], [[nausea]], [[vomiting]], [[diarrhea]], increase in appetite and weight, weakness or [[fatigue]], [[polydipsia]], and [[peripheral edema]].

* Although not reported with thiothixene, evidence indicates there is a relationship between [[phenothiazine]] therapy and the occurrence of a [[systemic lupus erythematosus]]-like syndrome.

=====[[Neuroleptic Malignant Syndrome]] (NMS)=====

* Please refer to the text regarding NMS in the WARNINGS section.

* NOTE: Sudden deaths have occasionally been reported in patients who have received certain [[phenothiazine]] derivatives. In some cases the cause of death was apparently cardiac arrest or asphyxia due to failure of the cough reflex. In others, the cause could not be determined nor could it be established that death was due to [[phenothiazine]] administration.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|drugInteractions=* Hepatic microsomal enzyme inducing agents, such as carbamazepine, were found to significantly increase the clearance of thiothixene. Patients receiving these drugs should be observed for signs of reduced thiothixene effectiveness4,5.

* Due to a possible additive effect with [[hypotensive]] agents, patients receiving these drugs should be observed closely for signs of excessive [[hypotension]] when thiothixene is added to their drug regimen.
|useInPregnancyFDA=* '''Pregnancy Category'''
|AUSPregCat=C
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.

<!--Administration and Monitoring-->
|administration=* Oral
* Intramuscular
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.

* Description

<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.

<!--Overdosage-->
|overdose=* 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]].
|drugBox={{Drugbox2
| verifiedrevid = 470609114
| IUPAC_name = (9''Z'')-''N,N''-dimethyl-9-[3-(4-methylpiperazin-1-yl)propylidene]-9''H''-thioxanthene-2-sulfonamide
| image = Thiothixene.png
| width = 220

<!--Clinical data-->
| tradename = Navane
| Drugs.com = {{drugs.com|monograph|thiothixene}}
| MedlinePlus = a682867
| pregnancy_category =  
| legal_status = Rx-only
| routes_of_administration = Oral

<!--Pharmacokinetic data-->
| bioavailability =  
| metabolism = Hepatic
| elimination_half-life = 10-20 hours
| excretion =  

<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 5591-45-7
| ATC_prefix = N05
| ATC_suffix = AF04
| PubChem = 941651
| IUPHAR_ligand = 212
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB01623
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 819430
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 7318FJ13YJ
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 1201

<!--Chemical data-->
| C=23 | H=29 | N=3 | O=2 | S=2 
| molecular_weight = 443.627 g/mol
| smiles = O=S(=O)(N(C)C)c2cc1C(\c3c(Sc1cc2)cccc3)=C/CCN4CCN(C)CC4
| InChI = 1/C23H29N3O2S2/c1-24(2)30(27,28)18-10-11-23-21(17-18)19(20-7-4-5-9-22(20)29-23)8-6-12-26-15-13-25(3)14-16-26/h4-5,7-11,17H,6,12-16H2,1-3H3/b19-8-
| InChIKey = GFBKORZTTCHDGY-UWVJOHFNBF
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C23H29N3O2S2/c1-24(2)30(27,28)18-10-11-23-21(17-18)19(20-7-4-5-9-22(20)29-23)8-6-12-26-15-13-25(3)14-16-26/h4-5,7-11,17H,6,12-16H2,1-3H3/b19-8-
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = GFBKORZTTCHDGY-UWVJOHFNSA-N
}}
|mechAction=* Thiothixene is an antipsychotic of the thioxanthene series. Thiothixene possesses certain chemical and pharmacological similarities to the piperazine phenothiazines and differences from the aliphatic group of phenothiazines.

<!--Structure-->
|structure=* Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula:

[[File:Thiothixene structure.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]

<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.

<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.

<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.

<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.

<!--How Supplied-->
|howSupplied=Thiothixene Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP.

The 1 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a powder blue opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 1001 in black ink on both the cap and body. They are available as follows:

NDC 0378-1001-01
bottles of 100 capsules

The 2 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a yellow opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 2002 in black ink on both the cap and body. They are available as follows:

NDC 0378-2002-01
bottles of 100 capsules

NDC 0378-2002-10
bottles of 1000 capsules

The 5 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a white opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 3005 in black ink on both the cap and body. They are available as follows:

NDC 0378-3005-01
bottles of 100 capsules

NDC 0378-3005-10
bottles of 1000 capsules

The 10 mg capsule is a hard-shell gelatin capsule with a caramel opaque cap and a peach opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 5010 in black ink on both the cap and body. They are available as follows:

NDC 0378-5010-01
bottles of 100 capsules

NDC 0378-5010-10
bottles of 1000 capsules
|storage=* Store at 20° to 25°C (68° to 77°F).

* Protect from light.

* Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
|packLabel=====PRINCIPAL DISPLAY PANEL====

=====PRINCIPAL DISPLAY PANEL - 1 mg=====

NDC 0378-1001-01

Thiothixene 
Capsules, USP 
1 mg

Rx only    100 Capsules

Each capsule contains:
Thiothixene, USP            1 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication 
out of the reach of children.

Store at 20° to 25°C (68° to 77°F). 
[See USP Controlled Room 
Temperature.]

Protect from light.

Dosage - In mild conditions:
6 mg to 15 mg daily. In severe
conditions: 10 mg to 60 mg daily.

Usual Optimal Dosage: 20 mg to
30 mg daily. See insert.

Mylan Pharmaceuticals Inc. 
Morgantown, WV 26505 U.S.A.

RM1001A10

[[File:Thiothixene drug lable01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]

=====PRINCIPAL DISPLAY PANEL - 2 mg=====

NDC 0378-2002-01

Thiothixene 
Capsules, USP 
2 mg

Rx only    100 Capsules

Each capsule contains:
Thiothixene, USP           2 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication 
out of the reach of children.

Store at 20° to 25°C (68° to 77°F). 
[See USP Controlled Room 
Temperature.]

Protect from light.

Dosage - In mild conditions:
6 mg to 15 mg daily. In severe
conditions: 10 mg to 60 mg daily.

Usual Optimal Dosage: 20 mg to
30 mg daily. See insert.

Mylan Pharmaceuticals Inc. 
Morgantown, WV 26505 U.S.A.

RM2002A8

[[File:Thiothixene drug lable02.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]

=====PRINCIPAL DISPLAY PANEL - 5 mg=====

NDC 0378-3005-01

Thiothixene 
Capsules, USP 
5 mg

Rx only    100 Capsules

Each capsule contains:
Thiothixene, USP             5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication 
out of the reach of children.

Store at 20° to 25°C (68° to 77°F). 
[See USP Controlled Room 
Temperature.]

Protect from light.

Dosage - In mild conditions:
6 mg to 15 mg daily. In severe
conditions: 10 mg to 60 mg daily.

Usual Optimal Dosage: 20 mg to
30 mg daily. See insert.

Mylan Pharmaceuticals Inc. 
Morgantown, WV 26505 U.S.A.

RM3005A9

[[File:Thiothixene drug lable03.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]

=====PRINCIPAL DISPLAY PANEL - 10 mg=====

NDC 0378-5010-01

Thiothixene 
Capsules, USP 
10 mg

Rx only    100 Capsules

Each capsule contains:
Thiothixene, USP          10 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication 
out of the reach of children.

Store at 20° to 25°C (68° to 77°F). 
[See USP Controlled Room 
Temperature.]

Protect from light.

Dosage - In mild conditions:
6 mg to 15 mg daily. In severe
conditions: 10 mg to 60 mg daily.

Usual Optimal Dosage: 20 mg to
30 mg daily. See insert.

Mylan Pharmaceuticals Inc. 
Morgantown, WV 26505 U.S.A.

RM5010A9

[[File:Thiothixene drug lable04.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=* Given the likelihood that some patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

<!--Brand Names-->
|brandNames=* Navane®
|lookAlike=* Navane® - Norvasc®
|drugShortage=
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[[Category:Drug]]