מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
APOTEX INC
C10BX03
ATORVASTATIN AND AMLODIPINE
5MG; 20MG
TABLET
AMLODIPINE (AMLODIPINE BESYLATE) 5MG; ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 20MG
ORAL
100
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0251555002; AHFS:
APPROVED
2013-08-23
_APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin tablets) Page 1 of 83 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-AMLODIPINE-ATORVASTATIN Amlodipine Besylate and Atorvastatin Calcium Tablets Amlodipine Besylate and Atorvastatin (as atorvastatin calcium propylene glycol solvate) Tablets, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg, Oral Apotex Standard Anti-hypertensive/Anti-anginal Agent and Lipid Metabolism Regulator APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: AUG 23, 2013 Date of Revision: MAY 19, 2023 Submission Control Number.: 270896 _APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin tablets) Page 2 of 83 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 05/2023 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 05/2023 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 ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations .......................................................... קרא את המסמך השלם