Country: Canada
Language: English
Source: Health Canada
CLARITHROMYCIN
SANIS HEALTH INC
J01FA09
CLARITHROMYCIN
250MG
GRANULES FOR SUSPENSION
CLARITHROMYCIN 250MG
ORAL
105ML
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0123752004; AHFS:
APPROVED
2013-07-26
_CLARITHROMYCIN _ _Page 1 of 84 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CLARITHROMYCIN Clarithromycin Tablets Film-coated tablets, 250 mg and 500 mg, Oral Manufacturer’s Standard Antibiotic NOTE: WHEN USED IN COMBINATION WITH ACID ANTISECRETORY DRUGS AND OTHER ANTIMICROBIALS FOR THE ERADICATION OF HELICOBACTER PYLORI, THE PRODUCT MONOGRAPH FOR THOSE AGENTS SHOULD BE CONSULTED. Sanis Health Inc. 1 President’s Choice Circle Brampton, Ontario L6Y 5S5 Submission Control Number: 268808 Date of Initial Authorization: MAR 22, 2021 Date of Revision: NOV 8, 2022 _CLARITHROMYCIN _ _Page 2 of 84 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 11/2022 7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2 Breast-feeding 11/2022 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 ....................................................................................................................... 5 1.2 Geriatrics ....................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 6 4 DOSAGE AND ADMINISTRATION .................................................................................... 7 4.1 Dosing Considerations ............................................ Read the complete document