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

Thiothixene

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
WARNINGS

DESCRIPTION


DESCRIPTION





CLINICAL PHARMACOLOGY



INDICATIONS & USAGE



CONTRAINDICATIONS



WARNINGS

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

Tardive Dyskinesia





Information for Patients in the PRECAUTIONSADVERSE REACTIONS

Neuroleptic Malignant Syndrome (NMS)





Usage in Pregnancy



Usage in Children




PRECAUTIONS









Leukopenia, Neutropenia and Agranulocytosis

Class Effect




INFORMATION FOR PATIENTS



DRUG INTERACTIONS




ADVERSE REACTIONS

NOTE:

Cardiovascular Effects


CNS Effects




Extrapyramidal Symptoms
Adverse Reactions: 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)
WARNINGS


OVERDOSAGE



Treatment





DOSAGE & ADMINISTRATION








HOW SUPPLIED





















STORAGE AND HANDLING





REFERENCES










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Thiothixene

Thiothixene CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-631(NDC:0378-2002)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
THIOTHIXENE THIOTHIXENE 2 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
cellulose, microcrystalline
POWDERED CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
GELATIN
titanium dioxide
FERROSOFERRIC OXIDE
propylene glycol
SHELLAC
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
yellow 12 mm MYLAN;2002 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-631-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071093 2011-12-07


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