TRIFLUOPERAZINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE)

Available from:

AA PHARMA INC

ATC code:

N05AB06

INN (International Name):

TRIFLUOPERAZINE

Dosage:

1MG

Pharmaceutical form:

TABLET

Composition:

TRIFLUOPERAZINE (TRIFLUOPERAZINE HYDROCHLORIDE) 1MG

Administration route:

ORAL

Units in package:

100/1000

Prescription type:

Prescription

Therapeutic area:

PHENOTHIAZINES

Product summary:

Active ingredient group (AIG) number: 0131362001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-05-26

Summary of Product characteristics

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_TRIFLUOPERAZINE _
_Page 1 of 22 _
PRESCRIBING INFORMATION
TRIFLUOPERAZINE
Trifluoperazine Hydrochloride Tablets BP
1, 2, 5, 10 and 20 mg
ANTIANXIETY-ANTIEMETIC-ANTIPSYCHOTIC
AA PHARMA INC.
1165 CREDITSTONE ROAD, UNIT #1
VAUGHAN, ONTARIO
L4K 4N7
DATE OF REVISION:
OCTOBER 9, 2014
SUBMISSION CONTROL NO: 173661
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_TRIFLUOPERAZINE _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION………………………………….....3
SUMMARY PRODUCT
INFORMATION……………………………………………....3
INDICATIONS AND CLINICAL
USE………………………………………………….3
CONTRAINDICATIONS………………………………………………………………...4
WARNINGS AND
PRECATIONS………………………………………………………4
DRUG
INTERACTIONS………………………………………………………………..12
DOSAGE AND
ADMINISTRATION…………………………………………………..14
OVERDOSAGE…………………………………………………………………………15
ACTION AND CLINCAL
PHARMACOLOGY……………………………………….16
STORAGE AND
STABILITY…………………………………………………………..16
DOSAGE FORMS, COMPOSITION AND
PACKAGING…………………………….17
PART II: SCIENTIFIC
INFORMATION…………………………………………………...18
PHARMCEUTICAL
INFORMATION……….………………….…………………......18
PART III: CONSUMER
INFORMATION……………………………………………..……19
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_TRIFLUOPERAZINE _
_Page 3 of 22 _
TRIFLUOPERAZINE
(Trifluoperazine Hydrochloride)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
oral
Tablets:1 mg, 2 mg, 5
mg, 10 mg and 20 mg
carnauba wax, cornstarch, FD&C Blue #2
aluminum lake, hydroxypropyl methyl-
cellulose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose,
polye