CO BUSPIRONE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BUSPIRONE HYDROCHLORIDE

Disponível em:

COBALT PHARMACEUTICALS COMPANY

Código ATC:

N05BE01

DCI (Denominação Comum Internacional):

BUSPIRONE

Dosagem:

10MG

Forma farmacêutica:

TABLET

Composição:

BUSPIRONE HYDROCHLORIDE 10MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Resumo do produto:

Active ingredient group (AIG) number: 0116263001; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2012-08-02

Características técnicas

1
PRODUCT MONOGRAPH
Pr
_CO_ BUSPIRONE
Buspirone Hydrochloride Tablets
5 mg & 10 mg
USP
Anxiolytic
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Preparation:
December 15, 2004
Date of Revision:
November 14, 2005
Control Number: 102000
2
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION . . . . . . . . . . . . . . .
. . . . . . . . . . . . . 3
SUMMARY PRODUCT INFORMATION . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 3
INDICATIONS AND CLINICAL USE . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 3
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 3
WARNINGS AND PRECAUTIONS. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . 4
ADVERSE REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 7
DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 10
DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 14
SYMPTOMS AND TREATMENT OF OVERDOSAGE . . . . . . . . . . . . . . . . .
. . . . . . . 14
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 15
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 17
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 17
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 18
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 18
CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 19
DETAILED PHARMACOLOGY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . 19
MICROBIOLOGY . . . . . . . . . . . . . . . . . . . . . .