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SANDOZ 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: Sandoz Levofloxacin (levofloxacin tablets) is 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 Sandoz Levofloxacin and…
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.
Sandoz Levofloxacin Page 5 of 74 Unclassified / Non classifié Sandoz 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 Sandoz 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.
). Use of levofloxacin with other drugs may lead to drug-drug interactions (see
, Cardiovascular 09/2025 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 09/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed.
RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
6 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 ............................................................................................................ 9 5 OVERDOSAGE .............................................................................................................
• Sandoz Levofloxacin is 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 the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • 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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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.
4 Geriatrics and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 2 CONTRAINDICATIONS • Sandoz Levofloxacin is 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 the
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ...............................................................................................
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 17 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 ......................................................................... 33 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 33 PART II: SCIENTIFIC INFORMATION .......................................................................................
34 13 PHARMACEUTICAL INFORMATION ............................................................................ 34 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication .................................................................................... 2 Comparative Bioavailability Studies ...................................................................... 50 15 MICROBIOLOGY ........................................................................................................
51 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 57 17 SUPPORTING PRODUCT […]