Thiothixene description, usages, side effects, indications, overdosage, supplying and lots more!

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Thiothixene

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 (seeWARNINGS).


THIOTHIXENE DESCRIPTION


Thiothixene




ACTIONS


INDICATIONS & USAGE



THIOTHIXENE CONTRAINDICATIONS



WARNINGS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
BOXED WARNING

Tardive Dyskinesia





Information for PatientsADVERSE REACTIONS

Neuroleptic Malignant Syndrome (NMS)





Usage in Pregnancy



Usage in Children




PRECAUTIONS










Leukopenia, Neutropenia and Agranulocytosis:

Class Effect




INFORMATION FOR PATIENTS



DRUG INTERACTIONS




THIOTHIXENE ADVERSE REACTIONS



Cardiovascular Effects


CNS Effects




Extrapyramidal Symptoms
Dystonia: Class Effect

Dystonia

Class Effect


Persistent Tardive Dyskinesia

WARNINGS


Hepatic Effects


Hematologic Effects


Allergic Reactions


Endocrine/Reproductive


Autonomic Effects


Other Adverse Reactions



Neuroleptic Malignant Syndrome (NMS)
NMS


DOSAGE & ADMINISTRATION








OVERDOSAGE



Treatment





HOW SUPPLIED





















REFERENCES









PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Thiothixene

Thiothixene

Thiothixene

Thiothixene CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-416(NDC:0781-2228)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
THIOTHIXENE THIOTHIXENE 5 mg

Inactive Ingredients

Ingredient Name Strength
FD&C YELLOW NO. 6
GELATIN
lactose monohydrate
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
STARCH, CORN
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 14 mm GG597 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-416-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071529 2011-07-22


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