País: Canadá
Língua: inglês
Origem: Health Canada
IRBESARTAN; HYDROCHLOROTHIAZIDE
MINT PHARMACEUTICALS INC
C09DA04
IRBESARTAN AND DIURETICS
150MG; 12.5MG
TABLET
IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
30/100/1000
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0240086001; AHFS:
CANCELLED POST MARKET
2020-07-08
PRODUCT MONOGRAPH Pr MINT-IRBESARTAN/HCTZ (Irbesartan and hydrochlorothiazide Tablets) 150/12.5 mg, 300/12.5 mg and 300/25 mg Tablets House Standard Angiotensin II AT 1 Receptor Blocker / Diuretic Mint Pharmaceuticals Inc. Date of Revision: 1093 Meyerside Drive, Unit 1 August 26, 2019 Mississauga, Ontario L5T 1J6 CONTROL NO.: 230635 _ _ 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 ........................................................................................... 20 OVERDOSAGE ............................................................................................................................. 22 ACTION AND CLINICAL PHARMACOLOGY ......................................................................... 22 STORAGE AND STABILITY ...................................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................................... 26 PART II: SCIENTIFIC INFORMATION .................................................................................... 27 PHARMACEUTICAL INFORMATION ............................................................................... Leia o documento completo