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

WARNING
WARNINGS

PROCHLORPERAZINE MALEATE DESCRIPTION


Prochlorperazine Maleate






INDICATIONS & USAGE




WARNINGS



PROCHLORPERAZINE MALEATE CONTRAINDICATIONS






WARNINGS

Increased Mortality in Elderly Patients with Dementia-Related Psychosis



Tardive Dyskinesia






PRECAUTIONSADVERSE REACTIONS

Neuroleptic Malignant Syndrome (NMS)









Usage In Pregnancy



Pregnancy

Nonteratogenic Effects



Nursing Mothers


PRECAUTIONS

WARNINGS

12











3


1

2

3


Long-Term Therapy



4

4
Geriatric Use
PRECAUTIONSADVERSE REACTIONSDOSAGE AND ADMINISTRATION

Leukopenia, Neutropenia and Agranulocytosis



PROCHLORPERAZINE MALEATE ADVERSE REACTIONS

WARNINGS



Extrapyramidal Symptoms

5

5

Dystonia

Class Effect


Motor Restlessness



Pseudoparkinsonism


Tardive Dyskinesia





Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives






OVERDOSAGE

ADVERSE REACTIONS

Symptoms



Treatment






DOSAGE & ADMINISTRATION

dosage and administration

Elderly Patients


1. To Control Severe Nausea and Vomiting


Oral Dosage - Tablets


2. In Adult Psychiatric Disorders


Oral Dosage

Non-Psychotic Anxiety


Psychotic Disorders including Schizophrenia




DOSAGE AND ADMINISTRATION - CHILDREN


Dystonia

1. Severe Nausea and Vomiting in Children


Oral Dosage



2. In Children with Schizophrenia

Oral Dosage




HOW SUPPLIED









STORAGE AND HANDLING








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:49349-347(NDC:0378-5105)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C RED NO. 40
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
polyethylene glycol
STARCH, CORN
SODIUM LAURYL SULFATE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
red 6 mm M;P1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-347-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040185 2011-06-30


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