MYLAN-LOSARTAN HCTZ TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C09DA01

Designación común internacional (DCI):

LOSARTAN AND DIURETICS

Dosis:

50MG; 12.5MG

formulario farmacéutico:

TABLET

Composición:

LOSARTAN POTASSIUM 50MG; HYDROCHLOROTHIAZIDE 12.5MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0233168001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-05-10

Ficha técnica

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MYLAN-LOSARTAN HCTZ
Page 1 of 42
PRODUCT MONOGRAPH
Pr
MYLAN-LOSARTAN HCTZ
losartan potassium and hydrochlorothiazide tablets
50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg
Manufacturer’s standard
Angiotensin II Receptor Antagonist and Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
August 09, 2013
SUBMISSION CONTROL NUMBER: 166901
________________________________________________________________________________________________________
MYLAN-LOSARTAN HCTZ
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
.............................................................................................
8
DRUG INTERACTIONS
...........................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................
16
OVERDOSAGE
..........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................... 18
STORAGE AND STABILITY
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 21
PART II: SCIENTIFIC INFORMATION
.............................................................. 23
PHARMACEUTICAL INFORMATION
................................................................. 2