Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
QUINAPRIL (QUINAPRIL HYDROCHLORIDE); HYDROCHLOROTHIAZIDE
AURO PHARMA INC
C09BA06
QUINAPRIL AND DIURETICS
20MG; 25MG
TABLET
QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 20MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
2X14/90
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0231789003; AHFS:
APPROVED
2019-01-02
_AURO-QUINAPRIL HCTZ PRODUCT MONOGRAPH _ Page 1 of 56 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-QUINAPRIL HCTZ Quinapril and Hydrochlorothiazide Tablets, Tablets, 10 mg /12.5 mg, 20 mg /12.5 mg and 20 mg /25 mg Quinapril (as Quinapril Hydrochloride) / Hydrochlorothiazide, Oral House Standard Angiotensin Converting Enzyme Inhibitor/Diuretic AURO PHARMA INC 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8 Canada Date of Initial Authorization: January 02, 2019 Date of Revision: August 11, 2023 Submission Control Number: 272657 _AURO-QUINAPRIL HCTZ PRODUCT MONOGRAPH _ Page 2 of 56 RECENT MAJOR LABEL CHANGES N/A TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS ..................................................................................................................... 4 1.1 Pediatrics (<18 years of age) ....................................................................................... 4 1.2 Geriatrics (> 65 years of age) ...................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ....................................................................................... 5 4.1 Dosing Considerations ................................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ............... Baca dokumen lengkap