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

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Thioridazine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

WARNINGSCONTRAINDICATIONSINDICATIONS

WARNINGS

THIORIDAZINE HYDROCHLORIDE DESCRIPTION



Thioridazine Hydrochloride





CLINICAL PHARMACOLOGY


WARNINGSCONTRAINDICATIONS

INDICATIONS & USAGE

WARNINGSCONTRAINDICATIONS


THIORIDAZINE HYDROCHLORIDE CONTRAINDICATIONS


WARNINGSPRECAUTIONS
WARNINGS

WARNINGS

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

Potential for Proarrhythmic Effects


CONTRAINDICATIONSPRECAUTIONS


Tardive Dyskinesia





Information for PatientsADVERSE REACTIONS



Pregnancy

Nonteratogenic Effects



Neuroleptic Malignant Syndrome (NMS)





Central Nervous System Depressants


PRECAUTIONS




Drug Interactions
WARNINGSCONTRAINDICATIONS

Drugs That Inhibit Cytochrome P450 2D6


Drugs That Reduce the Clearance of Thioridazine Through Other Mechanisms

Fluvoxamine


Propranolol


Pindolol


Drugs That Prolong the QTc Interval


Information for Patients



Pediatric Use
DOSAGE AND ADMINISTRATION: Pediatric Patients

Leukopenia, Neutropenia and Agranulocytosis




THIORIDAZINE HYDROCHLORIDE ADVERSE REACTIONS



Central Nervous System


Autonomic Nervous System


Endocrine System


Skin


Cardiovascular System
WARNINGSPhenothiazine Derivatives: Cardiovascular Effects

Other


Post Introduction Reports


Phenothiazine Derivatives






WARNINGS

WARNINGS


WARNINGS




OVERDOSAGE

ADVERSE REACTIONS

Signs and Symptoms









Treatment

WARNINGSCONTRAINDICATIONS





1

1

DOSAGE & ADMINISTRATION

INDICATIONSWARNINGS

Adults


Pediatric Patients


HOW SUPPLIED
























































PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Thioridazine Hydrochloride



Thioridazine Hydrochloride





Thioridazine Hydrochloride



Thioridazine Hydrochloride

Thioridazine Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-128(NDC:0378-0614-10)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE 25 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
hydroxypropyl cellulose
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
SODIUM LAURYL SULFATE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
orange 7 mm M;58;25 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-128-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088004 2011-04-04


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