Country: Canada
Language: English
Source: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
COBALT PHARMACEUTICALS COMPANY
J01MA02
CIPROFLOXACIN
250MG
TABLET
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 250MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0123207006; AHFS:
CANCELLED PRE MARKET
2017-09-01
_ _ Ciprofloxacin_ _ _Page 1 of 46_ PRODUCT MONOGRAPH _PR_ CIPROFLOXACIN (Ciprofloxacin Tablets, USP) Tablets 250 mg, 500 mg, & 750 mg Ciprofloxacin (as Ciprofloxacin Hydrochloride) Antibacterial Agent Manufactured by: Cobalt Pharmaceuticals Company 6500 Kitimat Road Mississauga, Ontario L5N 2B8 Date of Revision: May 11, 2012 Submission Control No: 155219 _ _ Ciprofloxacin_ _ _Page 2 of 46_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 6 WARNINGS AND PRECAUTIONS................................................................................. 6 ADVERSE REACTIONS................................................................................................. 11 DRUG INTERACTIONS ................................................................................................. 14 DOSAGE AND ADMINISTRATION............................................................................. 16 OVERDOSAGE ............................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 19 STORAGE AND STABILITY......................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 22 PART II: SCIENTIFIC INFORMATION .............................................................................. 23 PHARMACEUTICAL INFORMATION......................................................................... 23 CLINICAL TRIALS...................................................................................................... Read the complete document