AURO-ALFUZOSIN TABLET (EXTENDED-RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ALFUZOSIN HYDROCHLORIDE

Disponível em:

AURO PHARMA INC

Código ATC:

G04CA01

DCI (Denominação Comum Internacional):

ALFUZOSIN

Dosagem:

10MG

Forma farmacêutica:

TABLET (EXTENDED-RELEASE)

Composição:

ALFUZOSIN HYDROCHLORIDE 10MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

Selective Alfa-1-Adrenergic Blocking Agents

Resumo do produto:

Active ingredient group (AIG) number: 0146806001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2015-07-02

Características técnicas

Page 1 of 42
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-ALFUZOSIN
Alfuzosin Hydrochloride
Prolonged-Release Tablets
10 mg
House Standard
SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
ADJUNCTIVE THERAPY IN ACUTE URINARY RETENTION (AUR)
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8, CANADA
Date of Revision:
April 5, 2019
Submission Control No.: 225758
Page 2 of 42
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
....................................………….............
6
DRUG INTERACTIONS
.............................……………................
11
DOSAGE AND ADMINISTRATION .............…............................
14
OVERDOSAGE
......................................………….........................
14
ACTION AND CLINICAL PHARMACOLOGY….........................
14
STORAGE AND STABILITY
........................................……..........
20
SPECIAL HANDLING INSTRUCTION…………………………..
21
DOSAGE FORMS, COMPOSITION AND PACKAGING…….....
21
PART II:
SCIENTIFIC INFORMATION
.........................…………….…....... 22
PHARMACEUTICAL INFORMATION ........................….............
22
CLINICAL TRIALS
...............................................……………......
23
DETAILED PHARMACOLOGY ..............................……………..
28
TOXICOLOGY
...........................…………………………............
31
BIBLIOGRAPHY.................................………………………….....
36
PART III:
PATIENT MEDICATION INFORMATION.....................………
40
Page 3 of 42
PR
AURO-ALFUZOSIN
Alfuzosin Hydrochloride
Prolonged-Rel