Country: Canada
Language: English
Source: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
J01MA02
CIPROFLOXACIN
250MG
TABLET
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 250MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207006; AHFS:
CANCELLED POST MARKET
2018-07-12
Page 1 of 58 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYLAN-CIPROFLOXACIN CIPROFLOXACIN TABLETS, USP 250 MG AND 500 MG (AS CIPROFLOXACIN HYDROCHLORIDE) ANTIBACTERIAL AGENT MYLAN PHARMACEUTICALS ULC 85 Advance Road Etobicoke, Ontario Canada M8Z 2S6 DATE OF REVISION: May 3, 2019 Control No.: 227162 Page 2 of 58 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION .................................................................................... 3 INDICATIONS AND CLINICAL USE ......................................................................................... 3 CONTRAINDICATIONS .............................................................................................................. 6 WARNINGS AND PRECAUTIONS ............................................................................................. 7 ADVERSE REACTIONS ............................................................................................................. 13 DRUG INTERACTIONS ............................................................................................................. 16 DOSAGE AND ADMINISTRATION ......................................................................................... 23 OVERDOSAGE ........................................................................................................................... 26 ACTION AND CLINICAL PHARMACOLOGY ........................................................................ 26 STORAGE AND STABILITY ..................................................................................................... 29 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................... 29 PART II: SCIENTIFIC INFORMATION ............................................................................... 30 PHARMACEUTICAL INFORMATION ..................................................................................... 30 CLINICAL TRIALS ....... Read the complete document