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LEVOFLOXACIN IN is a brand name for Levofloxacin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LEVOFLOXACIN IN 5% DEXTROSE INJECTION is indicated for the treatment of adults with bacterial infections caused by susceptible strains of the designated microorganisms in the infections listed below. Note: Since i.v. and oral formulations are interchangeable, i.v. administration is recommended only when it offers a…
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 1 Canadian clinical practice guidelines for acute and chronic rhinosinusitis. Desrosiers et al. Allergy, Asthma & 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. LEVOFLOXACIN in 5% Dextrose Injection Page 5 of 68 aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended. LEVOFLOXACIN IN 5% DEXTROSE INJECTION 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 LEVOFLOXACIN IN 5% DEXTROSE INJECTION 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.
). V. Administration Because rapid or bolus intravenous injection may result in hypotension, LEVOFLOXACIN INJECTION SHOULD ONLY BE ADMINISTERED BY SLOW INTRAVENOUS INFUSION OVER A PERIOD OF 60 MINUTES FOR A 250 MG OR A 500 MG DOSE, AND 90 MINUTES FOR A 750 MG DOSE (see 4 DOSAGE AND ADMINISTRATION).
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.
LEVOFLOXACIN in 5% Dextrose Injection Page 12 of 68 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.
08/2022 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 ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 9 5 OVERDOSAGE..............................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 16 8 ADVERSE REACTIONS ................................................................................................
20 9 DRUG INTERACTIONS ................................................................................................ 23 10 CLINICAL PHARMACOLOGY .......................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 28 PART II: SCIENTIFIC INFORMATION .......................................................................................
• LEVOFLOXACIN IN 5% DEXTROSE INJECTION is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. 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). LEVOFLOXACIN in 5% Dextrose Injection Page 6 of 68 2 CONTRAINDICATIONS • LEVOFLOXACIN IN 5% DEXTROSE INJECTION is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.
For a complete listing, see
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).
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 LEVOFLOXACIN IN 5% DEXTROSE INJECTION immediately and initiate appropriate therapy.
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 consciousness occurred within 3 days in most cases).
4 Drug-Drug Interactions). 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 […]
29 13 PHARMACEUTICAL INFORMATION ............................................................................ 29 14 CLINICAL TRIALS ........................................................................................................
30 15 MICROBIOLOGY ........................................................................................................ 47 16 NON-CLINICAL TOXICOLOGY .....................................................................................
54 PATIENT MEDICATION INFORMATION .................................................................................. 61 LEVOFLOXACIN in 5% Dextrose Injection Page 4 of 68 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS LEVOFLOXACIN IN 5% DEXTROSE INJECTION is indicated for the treatment of adults with bacterial infections caused by susceptible strains of the designated microorganisms in the infections listed below.
v. v. administration is recommended only when it offers a route of administration […]