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APO-LEVOFLOXACIN is a brand name for Levofloxacin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-LEVOFLOXACIN (levofloxacin tablets) are indicated for the treatment of adults with bacterial infections caused by susceptible strains of the designated microorganisms in the infections listed below. • To reduce the development of drug-resistant bacteria and maintain the effectiveness of APO- LEVOFLOXACIN and other…
Verbatim from this product's HC label. Tap a section to expand.
, and 14 CLINICAL TRIALS). Nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae or Streptococcus pneumoniae.
Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended. 1 Canadian clinical practice guidelines for acute and chronic rhinosinusitis.
Desrosiers et al. Allergy, Asthma and Clinical Immunology, 2011, 7:2 2 Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2008 update – highlights for primary care. O’Donnell et al. Can Respir J 2008; 15 (Suppl A): 1A-8A.
APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 5 of 76 APO-LEVOFLOXACIN is not indicated for acute bronchitis. • Skin and Skin Structure Uncomplicated skin and skin structure infections (mild to moderate) due to Staphylococcus aureus or Streptococcus pyogenes.
Complicated skin and skin structure infections (mild to moderate), excluding burns, due to Enterococcus faecalis, methicillin-sensitive Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis, or Streptococcus agalactiae. • Urinary Tract Complicated urinary tract infections (mild to moderate) due to Enterococcus (Streptococcus) faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae or Staphylococcus saprophyticus. Acute pyelonephritis (mild to moderate) caused by Escherichia coli (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis. In cases of uncomplicated acute bacterial cystitis, limit the use of APO-LEVOFLOXACIN to circumstances where no other treatment options are available.
A urine culture should be obtained prior to treatment to ensure levofloxacin susceptibility. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing the infection, and to determine their susceptibility to levofloxacin.
). 4 Drug-Drug Interactions). Sexually Transmitted Diseases Levofloxacin is not indicated for the treatment of syphilis or gonorrhea. Levofloxacin is not effective in the treatment of syphilis. Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis.
All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with antimicrobial agents with limited or no activity against Treponema pallidum should have a follow-up serologic test for syphilis after 3 months.
Cardiovascular Aortic Aneurysm and Aortic Dissection Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones.
Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones. , infective endocarditis).
The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids. In case of sudden severe abdominal, chest or back pain, acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities, patients should be advised to immediately consult a physician in an emergency department.
QT Prolongation Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. During post-marketing surveillance, very rare cases of torsades de pointes have been reported in patients taking levofloxacin.
These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. , amiodarone, sotalol) antiarrhythmic agents, and cisapride. 2 Pharmacodynamics, Studies Measuring Effects on QT and Corrected QT (QTc) Intervals).
, Cardiovascular 02/2025 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 02/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
1 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ............................................................................................................. 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ..............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration .......................................................................................................... 5 Missed Dose ..............................................................................................................
8 5 OVERDOSAGE............................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................
• APO-LEVOFLOXACIN tablets are contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING . • Levofloxacin is also contraindicated in persons with a history of tendinitis or tendon rupture associated with the use of any member of the quinolone group of antimicrobial agents.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Levofloxacin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Therapy with levofloxacin may be initiated before the results of these tests are known; once results become available, appropriate therapy should be continued. As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin.
Culture and susceptibility testing performed periodically during therapy, will reveal not only the therapeutic effect of the antimicrobial agent, but also the possible emergence of bacterial resistance. 3 Pediatrics). 2 Geriatrics Geriatrics (≥ 65 years of age): Drug absorption appears to be unaffected by age.
3 Pharmacokinetics, Special Populations and Conditions). APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 6 of 76 2 CONTRAINDICATIONS • APO-LEVOFLOXACIN tablets are contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
Driving and Operating Machinery Neurologic adverse effects such as dizziness and lightheadedness may occur. Therefore, patients should know how they react to levofloxacin before operating an automobile or machinery or engaging in other activities requiring mental alertness and coordination.
, 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 APO-LEVOFLOXACIN immediately and initiate appropriate therapy.
4 Drug-Drug Interactions, Antidiabetic Agents). Hypoglycemic coma has been observed in diabetic patients with the use of levofloxacin. Fatal outcomes have been reported. All cases of hypoglycemic coma had multiple confounding factors; a temporal relationship with the use of levofloxacin was identified (onset of altered APO-LEVOFLOXACIN (Levofloxacin Tablets) Page 12 of 76 consciousness occurred within 3 days in most cases).
4 Drug-Drug Interactions, Antidiabetic Agents). Gastrointestinal Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including levofloxacin. CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium […]
1 Special Populations ................................................................................................. 1 Pregnant Women .............................................................................................. 2 Breast-feeding ...................................................................................................
3 Pediatrics........................................................................................................... 4 Geriatrics ...........................................................................................................
16 8 ADVERSE REACTIONS................................................................................................ 1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions ..............................................................................
1 Clinical Trial Adverse Reactions – Pediatrics..................................................... 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 ....................................................................................
4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions.......................................................................... 25 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 27 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 34 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
34 PART II: SCIENTIFIC INFORMATION ...................................................................................... 35 13 PHARMACEUTICAL INFORMATION ........................................................................... 35 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication ..................................................................................... 2 Comparative Bioavailability Studies ....................................................................... 53 15 MICROBIOLOGY .......................................................................................................
54 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 59 17 SUPPORTING PRODUCT MONOGRAPHS […]