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Levofloxacin (United States: Not available) (oral inhalation): Drug information

Levofloxacin (United States: Not available) (oral inhalation): Drug information
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For additional information see "Levofloxacin (United States: Not available) (oral inhalation): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • Quinsair
Pharmacologic Category
  • Antibiotic, Fluoroquinolone
Dosing: Adult
Cystic fibrosis

Cystic fibrosis: Inhalation: 240 mg every 12 hours in alternating cycles of 28 days on treatment followed by 28 days off treatment. Safety and efficacy of use beyond 6 months (3 consecutive cycles) have not been established.

Missed dose: If a dose is missed, administer as soon as possible, provided that as close as possible to a 12-hour interval (≥8-hour interval) is allowed before administering the next dose. Do not use contents of >1 ampule to compensate for the missed dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Renal function may be estimated using the Cockcroft-Gault formula for dosage adjustment purposes.

CrCl ≥20 mL/minute: No dosage adjustment necessary.

CrCl <20 mL/minute: Use is not recommended.

Dosing: Liver Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Dysgeusia (31%)

1% to 10%:

Cardiovascular: Chest discomfort (2%)

Dermatologic: Skin rash (1%)

Gastrointestinal: Nausea (3%), vomiting (1%)

Nervous system: Asthenia (≤2%), fatigue (≤2%), headache (1%), voice disorder (1%)

Respiratory: Cough (10%; including productive cough), discoloration of sputum (1%), dyspnea (1%; including dyspnea on exertion), hemoptysis (3%), increased bronchial secretions (5%), paranasal sinus hypersecretion (1%), reduced forced expiratory volume (1%), respiratory congestion (2%), thickening of bronchial secretions (2%)

<1%:

Cardiovascular: Chest pain, ECG abnormality (QRS complex abnormal)

Dermatologic: Burning sensation of skin, onychomycosis, pruritus, skin blister, sunburn

Endocrine & metabolic: Weight loss

Gastrointestinal: Decreased appetite, diarrhea, dysphagia, gastroesophageal reflux disease, increased appetite, oral candidiasis, oral discomfort, retching, upper abdominal pain

Genitourinary: Urine discoloration, vulvovaginal candidiasis

Hepatic: Abnormal hepatic function tests (including increased serum alanine aminotransferase, increased serum aspartate aminotransferase)

Nervous system: Aphonia, cluster headache, dizziness, feeling hot, jitteriness, migraine, neuralgia

Neuromuscular & skeletal: Arthropathy, costochondritis, joint sprain, joint stiffness, limb pain, muscle fatigue, muscle strain, plantar fasciitis, tendinopathy

Ophthalmic: Blurred vision, tunnel vision

Renal: Increased serum creatinine

Respiratory: Bronchospasm, decreased lung function (pulmonary function test decreased), epistaxis, flu-like symptoms, lower respiratory tract infection, nasal congestion, nasopharyngitis, obstructive pulmonary disease, oropharyngeal pain, pharyngeal erythema, rales, rhinorrhea, sinus headache, sneezing, throat irritation, wheezing

Miscellaneous: Decreased exercise tolerance, fever

Frequency not defined:

Cardiovascular: Prolonged QT interval on ECG

Endocrine & metabolic: Hyperglycemia, hypoglycemia

Hypersensitivity: Severe hypersensitivity reaction (including anaphylaxis)

Nervous system: Exacerbation of myasthenia gravis, peripheral neuropathy, psychiatric signs and symptoms (including agitation, anxiety, confusion, delirium, depression, disorientation, disturbance in attention, hallucination, increased intracranial pressure, insomnia, memory impairment, nervousness, nightmares, paranoid ideation, restlessness, suicidal ideation, suicidal tendencies, toxic psychosis, tremor), seizure

Neuromuscular & skeletal: Rupture of tendon

Contraindications

Hypersensitivity to levofloxacin, other quinolones, or any component of the formulation; history of tendinitis or tendon rupture associated with use of any quinolone.

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: [Canadian Boxed Warning]: Fluoroquinolones may prolong QTc interval and have infrequently caused arrhythmia; systemic use of levofloxacin has been associated with torsades de pointes (rare). Avoid use in patients with a history of QTc prolongation, significant bradycardia, cardiomyopathy, myocardial ischemia, uncorrected hypokalemia, or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).

• Aortic aneurysm and dissection: Fluoroquinolones have been associated with increased risk of aortic aneurysm and dissection, particularly in older adults. Fluoroquinolones should only be used in patients with a known history of aortic aneurysm and/or aortic dissection or those at increased risk, including patients with atherosclerosis, hypertension, genetic disorders involving blood vessel changes (eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet disease), after careful benefit-risk assessment.

• Bronchospasm: Bronchospasm may occur. If acute, symptomatic bronchospasm occurs after administration, patient may benefit from use of a short-acting bronchodilator prior to subsequent doses; discontinue use if an allergic reaction is suspected.

• Cough: Cough may occur; consider use of alternative therapy in patients with continued therapy-induced cough.

• CNS effects: Toxic psychosis, increased intracranial pressure (including pseudotumor cerebri), tremor, restlessness, anxiety, lightheadedness, dizziness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts may occur; use with caution in patients with known or suspected CNS disorder and use extreme caution in unstable psychiatric illness. Discontinue in patients who experience significant CNS adverse effects. Caution patients not to drive or use machinery if dizziness, fatigue, asthenia, or other CNS effects affecting ability to concentrate or react occur.

• Crystalluria: Rarely, crystalluria has occurred with other quinolones; urine alkalinity may increase the risk. Ensure adequate hydration during therapy.

• Glucose regulation: Systemic use of fluoroquinolones has been associated with the development of serious, and sometimes fatal, hypoglycemia. These events have occurred most often in in patients with diabetes treated with an oral hypoglycemic agent and/or insulin, but have also been reported in patients without a prior history of diabetes. Prompt identification and treatment of hypoglycemia is essential. Individual quinolones may differ in their potential to cause this effect. It was most evident with gatifloxacin (no longer marketed as systemic formulation). Hyperglycemia has also been associated with the use of fluoroquinolones. Patients should be monitored closely for signs/symptoms of disordered glucose regulation.

• Hemoptysis: Hemoptysis may occur. Continue treatment in patients with clinically significant hemoptysis only if benefits of treatment outweigh the risks of inducing further hemorrhage.

• Hepatotoxicity: Unrelated to hypersensitivity, severe hepatotoxicity (including acute hepatitis and fatalities) has been reported with systemically administered levofloxacin (generally within 2 weeks). Elderly patients may be at greater risk. Discontinue therapy immediately if signs and symptoms of hepatitis occur.

• Hypersensitivity reactions: [Canadian Boxed Warning]: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy and have occasionally been fatal. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Ophthalmic effects: Consult an eye specialist if visual disturbances occur; caution patients not to drive or use machinery.

• Peripheral neuropathy: Peripheral neuropathy has been reported (rare); may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur.

• Phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe phototoxicity reactions. Discontinue use if photosensitivity occurs.

• Seizures: [Canadian Boxed Warning]: Seizures may occur; use with extreme caution in individuals predisposed to seizures or with conditions known to lower seizure threshold. Avoid use in patients with a history of epilepsy.

• Serious adverse reactions: [Canadian Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions, including (but not limited to) tendinitis and tendon rupture, peripheral neuropathy, and neuropsychiatric effects.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

• Tendon inflammation/rupture: [Canadian Boxed Warning]: There have been reports of tendon inflammation and/or rupture with quinolone antibiotics; risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients >60 years. Rupture of the Achilles tendon sometimes requiring surgical repair has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Independent risk factors for tendinopathy include strenuous physical activity, renal failure, and previous tendon disorders (eg, rheumatoid arthritis). Discontinue at first sign of tendon inflammation or pain. May occur up to several months after discontinuation of therapy.

Disease-related concerns:

• Myasthenia gravis: [Canadian Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support and deaths have been reported.

• Renal impairment: Use with caution in patients with renal impairment; not recommended in patients with CrCl <20 mL/min. May increase risk of tendon rupture.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.

Special populations:

• Older adult: Adverse effects (eg, hepatotoxicity, tendon rupture, QT changes) may be increased in the elderly.

• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with latent or actual G6PD deficiency.

Other warnings/precautions:

• Appropriate use: For oral inhalation only. Use only with the Zirela Nebulizer system; do not use with any other device. Safety and efficacy of use beyond 6 months (3 consecutive cycles) have not been established.

Product Availability

Not available in the US

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Inhalation:

Quinsair: 240 mg/2.4 mL (2.4 mL)

Administration: Adult

Inhalation: Inhale over ~5 minutes using nebulizer handset recommended by manufacturer (see product labeling). Do not mix levofloxacin with other medications. In patients taking multiple inhaled therapies, recommended order of administration is: bronchodilators, dornase alfa, airway clearance techniques, levofloxacin, inhaled steroids. If acute asymptomatic bronchospasm occurs after levofloxacin administration, may use a short-acting inhaled bronchodilator ≥15 minutes to ≤4 hours prior to subsequent doses of levofloxacin.

Use: Labeled Indications

Note: Not approved in the US.

Cystic fibrosis: Management of cystic fibrosis in patients 18 years and older with chronic pulmonary Pseudomonas aeruginosa infections.

Limitations of use: Safety and efficacy not demonstrated in patients with FEV1 <25% or >85% predicted, or patients colonized with Burkholderia cepacia.

Medication Safety Issues
Sound-alike/look-alike issues:

LevoFLOXacin may be confused with levETIRAcetam, levodopa, Levophed, levothyroxine.

Other safety concerns:

ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.

Metabolism/Transport Effects

Substrate of OAT1/3;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Blood Glucose Lowering Effects: Quinolones may increase hypoglycemic effects of Agents with Blood Glucose Lowering Effects. Quinolones may decrease therapeutic effects of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Amiodarone: Levofloxacin-Containing Products (Systemic) may increase QTc-prolonging effects of Amiodarone. Risk X: Avoid

Amisulpride (Oral): May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk C: Monitor

Amphetamines: May increase cardiotoxic effects of Quinolones. Risk C: Monitor

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

Corticosteroids (Systemic): May increase adverse/toxic effects of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor

Dabrafenib: QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Delamanid: May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of Delamanid. Management: Avoid concomitant use of delamanid and quinolone antibiotics if possible. If coadministration is considered to be unavoidable, frequent monitoring of electrocardiograms throughout the full delamanid treatment period should occur. Risk D: Consider Therapy Modification

Domperidone: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Fluorouracil Products: QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Haloperidol: May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Hydroxychloroquine: May increase hyperglycemic effects of Levofloxacin-Containing Products (Systemic). Hydroxychloroquine may increase hypoglycemic effects of Levofloxacin-Containing Products (Systemic). Hydroxychloroquine may increase QTc-prolonging effects of Levofloxacin-Containing Products (Systemic). Risk C: Monitor

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Levoketoconazole: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Levoketoconazole. Risk X: Avoid

Methadone: Levofloxacin-Containing Products (Systemic) may increase QTc-prolonging effects of Methadone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Methylphenidate: May increase cardiotoxic effects of Quinolones. Risk C: Monitor

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Nadifloxacin: May increase adverse/toxic effects of Quinolones. Risk X: Avoid

Nonsteroidal Anti-Inflammatory Agents: May increase neuroexcitatory and/or seizure-potentiating effects of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase serum concentration of Quinolones. Risk C: Monitor

Ondansetron: May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Pentamidine (Systemic): May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Pimozide: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Piperaquine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Probenecid: May increase serum concentration of Quinolones. Probenecid may decrease excretion of Quinolones. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Risk C: Monitor

QT-prolonging Antidepressants (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Antipsychotics (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IA Antiarrhythmics (Highest Risk): Levofloxacin-Containing Products (Systemic) may increase QTc-prolonging effects of QT-prolonging Class IA Antiarrhythmics (Highest Risk). Risk X: Avoid

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class III Antiarrhythmics (Highest Risk): Levofloxacin-Containing Products (Systemic) may increase QTc-prolonging effects of QT-prolonging Class III Antiarrhythmics (Highest Risk). Risk X: Avoid

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Kinase Inhibitors (Highest Risk): May increase QTc-prolonging effects of Levofloxacin-Containing Products (Systemic). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Kinase Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Miscellaneous Agents (Highest Risk): Levofloxacin-Containing Products (Systemic) may increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Miscellaneous Agents (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Quinolone Antibiotics (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

Thioridazine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin K Antagonists: Quinolones may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Pregnancy Considerations

Levofloxacin crosses the placenta and can be detected in the amniotic fluid and cord blood following oral or intravenous administration (Ozyüncü 2010a; Ozyüncü 2010b).

[Canadian Boxed Warning]: There are limited data on the use of levofloxacin in pregnant women. Nonclinical studies suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism. Consider alternate inhalation therapy to levofloxacin during pregnancy.

Breastfeeding Considerations

[Canadian Boxed Warning]: Levofloxacin may be excreted in breast milk. In nonclinical studies, fluoroquinolones have been shown to damage weight-bearing cartilage of growing organisms. Based on data from a case report, small amounts of levofloxacin are excreted in breast milk following oral and intravenous administration (Cahill 2005). Due to the potential for serious adverse reactions in the breast-feeding infant, the manufacturer recommends a decision be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of treatment to the mother.

Monitoring Parameters

Evaluation of organ system functions (renal, hepatic, and hematopoietic) periodically during therapy; signs/symptoms of hypersensitivity or crystalluria; blood glucose (diabetic patients); bronchospasm or hemoptysis following administration.

Mechanism of Action

Inhibition of bacterial DNA gyrase and topoisomerase IV enzymes (both of which are type II topoisomerases) required for DNA replication, transcription, repair and recombination.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Systemic absorption following multiple dose oral inhalation is approximately equal to that observed following systemic administration of levofloxacin 250 to 500 mg

Distribution: Vd: ~250 L

Protein binding: ~30% to 40%

Metabolism: Minimal

Half-life elimination: 5 to 7 hours

Time to peak: 0.5 to 1 hour

Excretion: Renal (>85%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Quinsair;
  • (BG) Bulgaria: Quinsair;
  • (CH) Switzerland: Quinsair;
  • (DE) Germany: Quinsair;
  • (ES) Spain: Quinsair;
  • (FI) Finland: Quinsair;
  • (FR) France: Quinsair;
  • (GB) United Kingdom: Quinsair;
  • (GR) Greece: Quinsair;
  • (HU) Hungary: Quinsair;
  • (ID) Indonesia: Lfx;
  • (IE) Ireland: Quinsair;
  • (IT) Italy: Quinsair;
  • (LU) Luxembourg: Quinsair;
  • (NL) Netherlands: Quinsair;
  • (NO) Norway: Quinsair;
  • (PL) Poland: Quinsair;
  • (SE) Sweden: Quinsair;
  • (SI) Slovenia: Quinsair;
  • (SK) Slovakia: Quinsair
  1. Cahill JB Jr, Bailey EM, Chien S, et al. Levofloxacin secretion in breast milk: a case report. Pharmacotherapy. 2005; 25(1):116-118. [PubMed 15767227]
  2. Ozyüncü O, Beksac MS, Nemutlu E, Katlan D, Kir S. Maternal blood and amniotic fluid levels of moxifloxacin, levofloxacin and cefixime. J Obstet Gynaecol Res. 2010a;36(3):484-487. [PubMed 20598025]
  3. Ozyüncü O, Nemutlu E, Katlan D, Kir S, Beksac MS. Maternal and fetal blood levels of moxifloxacin, levofloxacin, cefepime and cefoperazone. Int J Antimicrob Agents. 2010b;36(2):175-178. [PubMed 20418070]
  4. Quinsair (levofloxacin solution for inhalation) [product monograph]. Vaughan, Ontario, Canada: Horizon Therapeutics Canada; March 2020.
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