Country: Canada
Language: English
Source: Health Canada
TERAZOSIN HYDROCHLORIDE
BGP PHARMA ULC
G04CA03
TERAZOSIN
1MG
TABLET
TERAZOSIN HYDROCHLORIDE 1MG
ORAL
100
Prescription
ALPHA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0121210003; AHFS:
CANCELLED POST MARKET
2016-02-19
_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 ............................................................. Read the complete document