ADVICOR TABLET (IMMEDIATE RELEASE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

NICOTINIC ACID; LOVASTATIN

Disponível em:

SEPRACOR PHARMACEUTICALS INC

Código ATC:

C10BA01

DCI (Denominação Comum Internacional):

LOVASTATIN AND NICOTINIC ACID

Dosagem:

500MG; 20MG

Forma farmacêutica:

TABLET (IMMEDIATE RELEASE)

Composição:

NICOTINIC ACID 500MG; LOVASTATIN 20MG

Via de administração:

ORAL

Unidades em pacote:

3/90

Tipo de prescrição:

Prescription

Área terapêutica:

HMG-COA REDUCTASE INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0251302001; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2012-08-02

Características técnicas

PRODUCT MONOGRAPH
PR
ADVICOR
®
extended-release niacin and lovastatin tablets
500/20 mg, 750/20 mg, 1000/20 mg and 1000/40 mg Film-Coated Tablets
Lipid Metabolism Regulator
Manufacturer:
DATE OF REVISION
:
Sepracor Pharmaceuticals, Inc.
OCTOBER 29, 2010
Mississauga, Ontario
Canada
CONTROL NO. 141231
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
.........................................................................................................
10
DRUG
INTERACTIONS..........................................................................................................
16
DOSAGE AND
ADMINISTRATION......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
19
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL
TRIALS...........................................................................................