HYTRIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TERAZOSIN HYDROCHLORIDE

Available from:

BGP PHARMA ULC

ATC code:

G04CA03

INN (International Name):

TERAZOSIN

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

TERAZOSIN HYDROCHLORIDE 2MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ALPHA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0121210002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-02-19

Summary of Product characteristics

_HYTRIN_
_®_
_ Product Monograph _
_Page 1 of 40 _
_ _
PRODUCT MONOGRAPH
PR
HYTRIN
®
terazosin hydrochloride tablets
1 mg, 2 mg, 5 mg and 10 mg
Antihypertensive Agent_ _
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
Date of Preparation:
January 7, 2015
BGP Pharma Inc.
8401 Trans-Canada Highway
St. Laurent, Qc H4S 1Z1
Submission Control Number: 180585
_HYTRIN_
_®_
_ Product Monograph _
_Page 2 of 40 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
.............................................................