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

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Prochlorperazine Maleate

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING




PROCHLORPERAZINE MALEATE DESCRIPTION


Prochlorperazine Maleate





INDICATIONS & USAGE








PROCHLORPERAZINE MALEATE CONTRAINDICATIONS






WARNINGS

Increased Mortality in Elderly Patients With Dementia-Related Psychosis



Tardive Dyskinesia








Neuroleptic Malignant Syndrome (NMS)









Pregnancy



Non-teratogenic Effects



Nursing Mothers


PRECAUTIONS
















Long-Term Therapy





Leukopenia, Neutropenia and Agranulocytosis




Geriatric Use


PROCHLORPERAZINE MALEATE ADVERSE REACTIONS





Extrapyramidal Reactions



Dystonia

Class effect


Motor Restlessness



Pseudo-parkinsonism


Tardive Dyskinesia




Adverse Reactions Reported With Prochlorperazine or Other Phenothiazine Derivatives






OVERDOSAGE



Symptoms



Treatment






DOSAGE & ADMINISTRATION

Adults


Elderly Patients


1. To Control Severe Nausea and Vomiting




2. In Adult Psychiatric Disorders







Children



1. Severe Nausea and Vomiting in Children





2. In Children With Schizophrenia





HOW SUPPLIED
















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Prochlorperazine Maleate



Prochlorperazine Maleate






Prochlorperazine Maleate

Prochlorperazine Maleate TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-148(NDC:0093-9652-01)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
POLYDEXTROSE
polyethylene glycol
STARCH, CORN
STEARIC ACID
titanium dioxide
triacetin
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
yellow 8 mm 93;9652 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-148-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040120 2011-04-11


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