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Thiothixene 10 mg Capsule, 100-count — NDC 70954-0017-10 package photo

Thiothixene 10 mg Capsule, 100-count

by ANI Pharmaceuticals, Inc. · 100 CAPSULE in 1 BOTTLE (70954-017-10)
NDC 70954-0017-10
🏷️ FDA NDC (as labeled) 70954-017-10 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$1.78 NADAC Per package$177.76 / 100 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $1.83/unit · Part D plans $2.19/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 70954-017-10
Product NDC 70954-017
11-digit billing NDC 70954001710
NCPDP billing unit EA — each (per item)
UNII 7318FJ13YJ
UPC 0370954015109, 0370954016106, 0370954014102, 0370954017103
Application # ANDA211642
SPL Set ID b067b400-66cd-422d-a631-9ce0c935d2b2
Established class (EPC) Typical Antipsychotic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-05
Route ORAL
Dosage form CAPSULE
Substance THIOTHIXENE
GPI-14 59300020100120
GPI class Thiothixene
GCN Seq No 003996
GCN 15691
HICL code 001668
Ingredient (HICL) Thiothixene
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7P
Therapeutic class — specific (HIC3) Antipsychotics,Dopamine Antagonists, Thioxanthenes
AHFS code 28:16.08.32
AHFS class Thioxanthenes
FDB label name THIOTHIXENE 10 MG CAPSULE
FDB brand name Thiothixene
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70954-017-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70954-0017-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Typical Antipsychotic class.

Pharmacologic class Typical Antipsychotic
Drug family (ATC) Thioxanthene derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerANI Pharmaceuticals, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA211642 (ANDA)
Labeler code70954
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio299 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name THIOTHIXENE 10 MG CAPSULE Ingredient Thiothixene
📖 What it is MedlinePlus · NLM

Thiothixene is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves). Thiothixene is in a group of medications called antipsychotics. It works by decreasing abnormal excitement in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Thiothixene is used to treat schizophrenia. It's an antipsychotic medication that helps manage the symptoms of this condition. Your prescriber will adjust your dose based on how se...
  • The label doesn't specify an exact timeframe, but antipsychotic medications like thiothixene are generally started at a low dose and gradually increased. It's important to keep tak...
  • How long does it take before I notice it working?
  • Some common ones include drowsiness, dry mouth, blurred vision, constipation, and lightheadedness — these often improve as your body adjusts. The ones to call your doctor about rig...
📖 Read our full Thiothixene guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Brown / Blue / Yellow / White / Pink
ShapeCapsule
Imprint017;capsule
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

17 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.778 $177.76 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $1.83 $183.01 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $2.19 $218.70 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
May 2023 Jan 2026 Apr 2026 Aug 2026 $2.633 $1.778
▼ Down 32% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
thiothixene 10 mg 60219-1676-01 Amneal 100 capsules $1.778 AB Availability likely
Thiothixene 10 mgthis 70954-0017-10 ANI 100 capsules $1.778 AB Availability likely
Thiothixene 10 mg 51407-0278-01 Golden 100 capsules AB FDA listed
Thiothixene 10 mg 67046-1542-03 Coupler 30 capsules AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70954-0017-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
435
Units reimbursed last 4 qtrs
31.5K
Gross reimbursed last 4 qtrs
$57.6K
Avg / prescription
$132.34
Avg / unit
$1.8301
Latest quarter Q4 2025
92Rx
Medicaid pays / ea
$1.8301
gross reimbursed
vs
NADAC / ea
$1.7776
acquisition cost
=
Spread
+$0.0525
+3% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
56% FFS 44% MCO
Fee-for-service · 245 Rx Managed care · 190 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 570 units · 4.4 per 100k residents PA New Jersey: 1,646 units · 17.7 per 100k residents NJ Massachusetts: no data reported MA California: 15,975 units · 41.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 2,346 units · 31.6 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,278 units · 27.9 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 8,321 units · 27.3 per 100k residents TX Florida: 1,320 units · 5.8 per 100k residents FL
Units reimbursed · per 100k residents
4.441.0
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 41.0 /100k
2 Arizona 31.6 /100k
3 Louisiana 27.9 /100k
4 Texas 27.3 /100k
5 New Jersey 17.7 /100k
6 Florida 5.8 /100k
7 Pennsylvania 4.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1000 capsules70954-0017-20 No Medicaid data
1 capsule70954-0017-40 No Medicaid data
Drug total (last 4 qtrs): 435 Rx · 31,456 units · $57,566 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Thiothixene — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Thiothixene. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$524.8K
Claims incl. refills
4.8K
Beneficiaries
2.1K
Spend / beneficiary
$253.54
Spend / claim
$108.28
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Thiothixene — the ingredient across all brands.

Top reported reactions

Diabetes Mellitus25
Weight Increased16
Depression15
Fatigue14
Nausea13
Dizziness12
Type 2 Diabetes Mellitus11

Age at onset

Adult8
Elderly2

Reporter sex

218 reports
Male · 35%
Female · 65%

Serious outcomes

Hospitalization77
Death21
Disabling10
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70954-0017-10 You're viewing this 100 CAPSULE in 1 BOTTLE (70954-017-10) $1.78 / ea $177.76 2019-04-05 Active
70954-0017-20 1000 CAPSULE in 1 BOTTLE (70954-017-20) 2019-04-05 Active
70954-0017-40 100 BLISTER PACK in 1 CARTON (70954-017-40) / 1 CAPSULE in 1 BLISTER PACK (70954-017-30) 2019-04-05 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 70954-0017-10?
NDC 70954-0017-10 is a 100-count package — 100 capsule in 1 bottle.
What is the difference between NDC 70954-0017-10 and NDC 70954-0017-40?
Both are Thiothixene 10 mg Capsule — the drug itself is identical. NDC 70954-0017-10 is the 100-count package, while NDC 70954-0017-40 is the 100 capsules package.
What NDC number is used to bill for this package of Thiothixene 10 mg Capsule?
Bill NDC 70954-0017-10 — the 11-digit billing format is 70954001710. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 185 words

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 ).

🎯 Indications and Usage 29 words

INDICATIONS & 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.

⏱️ Dosage and Administration 159 words

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.

Contraindications 58 words

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 ~3 min read

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 (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.

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 2 . 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 treatment of any concomitant serious medical problems for which specific treatments a…

🤒 Adverse Reactions ~3 min read

ADVERSE REACTIONS 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 (see Adverse Reactions: Dystonia: Class Effect).

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. (See WARNINGS.) 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, thrombocytop…

🔄 Drug Interactions 66 words

DRUG INTERACTIONS 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 effectiveness 4,5 . 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 6 .

🆘 Overdosage 160 words

OVERDOSAGE 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.

📦 How Supplied / Storage and Handling ~2 min read

HOW SUPPLIED Thiothixene Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP. Thiothixene, USP 1 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a blue opaque body filled with white to off-white powder. The capsule is imprinted “014” on the cap and “novitium” on the body in black ink.

They are available as below: NDC 70954-014-10 Bottle of 100 capsules NDC 70954-014-20 Bottle of 1000 capsules Thiothixene, USP 2 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a yellow opaque body filled with white to off-white powder. The capsule is imprinted “015” on the cap and “novitium” on the body in black ink. They are available as below: NDC 70954-015-10 Bottle of 100 capsules NDC 70954-015-20 Bottle of 1000 capsules NDC 70954-015-40 Unit dose blister packages of 100 (10 cards of 10 capsules each) Thiothixene, USP 5 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a white opaque body filled with white to off-white powder.

The capsule is imprinted “016” on the cap and “novitium” on the body in black ink. They are available as below: NDC 70954-016-10 Bottle of 100 capsules NDC 70954-016-20 Bottle of 1000 capsules NDC 70954-016-40 Unit dose blister packages of 100 (10 cards of 10 capsules each) Thiothixene, USP 10 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a peach opaque body filled with white to off-white powder. The capsule is imprinted “017” on the cap and “novitium” on the body in black ink.

They are available as below: NDC 70954-017-10 Bottle of 100 capsules NDC 70954-017-20 Bottle of 1000 capsules NDC 70954-017-40 Unit dose blister packages of 100 (10 cards of 10 capsules each) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Preserve in tight, light-resistant container as defined in the USP.

📋 Description 169 words

DESCRIPTION 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 The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration.

An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&C Blue No.

1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide.

In addition, the 1 mg empty gelatin capsules contain D&C Red No. 28 and the 2 mg empty gelatin capsules contain D&C Yellow No. 10.

The imprinting ink contains the following: ammonia solution, black iron oxide, potassium hydroxide, propylene glycol and shellac. Thio-structure

💬 Information for Patients 65 words

INFORMATION FOR PATIENTS 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.