Ország: Kanada
Nyelv: angol
Forrás: Health Canada
AMLODIPINE (AMLODIPINE BESYLATE)
DR. REDDY'S LABORATORIES INC
C08CA01
AMLODIPINE
5MG
TABLET
AMLODIPINE (AMLODIPINE BESYLATE) 5MG
ORAL
90/100/200/300/500
Prescription
DIHYDROPYRIDINES
Active ingredient group (AIG) number: 0131437002; AHFS:
CANCELLED PRE MARKET
2023-06-27
Page 1 of 33 PRODUCT MONOGRAPH PR AMLODIPINE BESYLATE TABLETS 5 mg and 10 mg amlodipine as amlodipine besylate Antihypertensive-Antianginal Agent MANUFACTURED BY: Date of Initial Approval: DR. REDDY’S LABORATORIES INC. December 14, 2009 107 College Road East, Princeton New Jersey, 08540 Date of Revision: USA October 24, 2022 IMPORTED AND DISTRIBUTED BY: DR. REDDY’S LABORATORIES CANADA INC. 5580 Explorer Drive, Suite 204 Mississauga, ON L4W 4Y1 Canada SUBMISSION CONTROL NO: 264381 Page 2 of 33 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 .............................................................................................. 6 DRUG INTERACTIONS .............................................................................................. 9 DOSAGE AND ADMINISTRATION.......................................................................... 14 OVERDOSAGE .......................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 16 STORAGE AND STABILITY..................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 19 PART II: SCIENTIFIC INFORMATI ON ........................................................................... 20 PHARMACEUTICAL INFORMATION ....................................................................... 20 DETAILED PHARMACOLOGY ......................... Olvassa el a teljes dokumentumot