NRA-CIPROFLOXACIN is a brand name for Ciprofloxacin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NRA‐Ciprofloxacin (ciprofloxacin tablet) may be indicated for the treatment of patients with the following infections caused by susceptible strains of the indicated microorganisms: Respiratory Tract Infections Acute exacerbation of chronic bronchitis caused by: Haemophilus influenzae Moraxella catarrhalis Acute…
Verbatim from this product's HC label. Tap a section to expand.
5 MISSED DOSE 05/2022 7 WARNINGS AND PRECAUTIONS 05/2022 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 ........................................................................................................................ 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 .......................................................... 4 Administration ....................................................................................................................
5 Missed Dose ........................................................................................................................ 11 5. OVERDOSAGE .....................................................................................................................
11 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 12 7. WARNINGS AND PRECAUTIONS.......................................................................................... 1 Special Populations .............................................................................................................
17 8. ADVERSE REACTIONS.......................................................................................................... 1 Adverse Reaction Overview ................................................................................................
). NRA-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 NRA‐Ciprofloxacin immediately and initiate appropriate therapy (see 8 ADVERSE REACTIONS and
05/2022 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 ........................................................................................................................ 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 .......................................................... 4 Administration ....................................................................................................................
5 Missed Dose ........................................................................................................................ 11 5. OVERDOSAGE .....................................................................................................................
11 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 12 7. WARNINGS AND PRECAUTIONS.......................................................................................... 1 Special Populations .............................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Clinical Trial Adverse Reactions ........................................................................................... 3 Less Common Clinical Trial Adverse Reactions....................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data...................................................................................................................................... 5 Post‐Market Adverse Reactions ..........................................................................................
20 9. DRUG INTERACTIONS.......................................................................................................... 2 Drug Interactions Overview.................................................................................................
3 Drug‐Behavioral Interactions .............................................................................................. 4 Drug‐Drug Interactions .......................................................................................................
5 Drug‐Food Interactions........................................................................................................ 6 Drug‐Herb Interactions .......................................................................................................
7 Drug‐Laboratory Test Interactions ...................................................................................... 27 10. CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action ........................................................................................................ 3 Pharmacokinetics ..............................................................................................................
27 11. 33 12. SPECIAL HANDLING INSTRUCTIONS .................................................................................. 34 13. 34 14. CLINICAL TRIALS ...............................................................................................................
2 Comparative Bioavailability Studies.................................................................................. 35 15. MICROBIOLOGY ...............................................................................................................
35 16. 39 17. SUPPORTING PRODUCT MONOGRAPHS .......................................................................... 43 PATIENT MEDICATION INFORMATION...................................................................................
44 NRA-CIPROFLOXACIN Page 4 of 64 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NRA‐Ciprofloxacin (ciprofloxacin tablet) may be indicated for the treatment of patients with the following infections caused by susceptible strains of the indicated microorganisms: Respiratory Tract Infections Acute exacerbation of chronic bronchitis caused by: Haemophilus influenzae Moraxella catarrhalis […]
17 8. ADVERSE REACTIONS.......................................................................................................... 1 Adverse Reaction Overview ................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................................... 3 Less Common Clinical Trial Adverse Reactions....................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data...................................................................................................................................... 5 Post‐Market Adverse Reactions ..........................................................................................
20 9. DRUG INTERACTIONS.......................................................................................................... 2 Drug Interactions Overview.................................................................................................
3 Drug‐Behavioral Interactions .............................................................................................. 4 Drug‐Drug Interactions .......................................................................................................
5 Drug‐Food Interactions........................................................................................................ 6 Drug‐Herb Interactions .......................................................................................................
7 Drug‐Laboratory Test Interactions ...................................................................................... 27 10. CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action ........................................................................................................ 3 Pharmacokinetics ..............................................................................................................
27 11. 33 12. SPECIAL HANDLING INSTRUCTIONS .................................................................................. 34 13. 34 14. CLINICAL TRIALS ...............................................................................................................
2 Comparative Bioavailability Studies.................................................................................. 35 15. MICROBIOLOGY ...............................................................................................................
35 16. 39 17. SUPPORTING PRODUCT MONOGRAPHS .......................................................................... 43 PATIENT MEDICATION INFORMATION...................................................................................
44 NRA-CIPROFLOXACIN Page 4 of 64 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NRA‐Ciprofloxacin (ciprofloxacin tablet) may be indicated for the treatment of patients with the following infections caused by susceptible strains of the indicated microorganisms: Respiratory Tract Infections Acute exacerbation of chronic bronchitis caused by: Haemophilus influenzae Moraxella catarrhalis Acute pneumonia caused by: Enterobacter cloacae […]