IPG-CIPROFLOXACIN

5 MISSED DOSE 02/2022 7 WARNINGS AND PRECAUTIONS 03/2020 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........................................................................................................................ 1 Pediatrics .......................................................................................................................

2 Geriatrics ....................................................................................................................... 7 2. CONTRAINDICATIONS ..........................................................................................................

7 3. SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................................... 8 4. DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ....................................................................................................

2 Recommended Dose and Dosage Adjustment Adults....................................................... 11 5. 11 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 122 7. 17 8. 20 9. 5 Drug-Food Interactions ................................................................................................

6 Drug-Herb Interactions ................................................................................................ 7 Drug-Laboratory Test Interactions................................................................................

277 10. CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action .................................................................................................

3 Pharmacokinetics ...................................................................................................... 277 11. STORAGE, STABILITY AND DISPOSAL ................................................................................

). IPG-CIPROFLOXACIN Page 13 of 64 Aortic Aneurysm and Aortic Dissection Epidemiologic studies report an increased risk of aortic aneurysm and aortic dissection after intake of fluoroquinolones, particularly in the older population.

, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, atherosclerosis). In case of sudden severe abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. SEVERE CASES OF HYPOGLYCEMIA RESULTING IN COMA OR DEATH HAVE BEEN REPORTED. If a hypoglycemic reaction occurs, discontinue IPG-Ciprofloxacin immediately and initiate appropriate therapy (see 8 ADVERSE REACTIONS and

03/2020 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........................................................................................................................ 1 Pediatrics .......................................................................................................................

2 Geriatrics ....................................................................................................................... 7 2. CONTRAINDICATIONS ..........................................................................................................

7 3. SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................................... 8 4. DOSAGE AND ADMINISTRATION .......................................................................................... 1 Dosing Considerations ....................................................................................................

2 Recommended Dose and Dosage Adjustment Adults....................................................... 11 5. 11 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 122 7. 17 8. 20 9. 5 Drug-Food Interactions ................................................................................................

6 Drug-Herb Interactions ................................................................................................ 7 Drug-Laboratory Test Interactions................................................................................

277 10. CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action .................................................................................................