Version May 2024
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.
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.
No dosage adjustment necessary.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. This product can produce systemic exposure to levofloxacin. See systemic levofloxacin for additional reactions.
>10%:
Gastrointestinal: Dysgeusia (31%)
1% to 10%:
Cardiovascular: Chest discomfort (2%)
Central nervous system: Fatigue (2%), headache (1%), speech disturbance (1%)
Dermatologic: Skin rash (1%)
Gastrointestinal: Nausea (3%), vomiting (1%)
Respiratory: Cough (10%), increased bronchial secretions (5%), hemoptysis (3%), respiratory congestion (2%), thickening of bronchial secretions (2%), discoloration of sputum (1%), dyspnea (1%), paranasal sinus hypersecretion (1%), reduced forced expiratory volume (1%)
<1%, postmarketing, and/or case reports: Abnormal alanine aminotransferase, abnormal aspartate transaminase, abnormal hepatic function tests, aphonia, arthropathy, blurred vision, bronchospasm, burning sensation of skin, chest pain, cluster headache, costochondritis, decreased appetite, decreased exercise tolerance, decreased lung function (pulmonary function test decreased), diarrhea, dizziness, dysphagia, dyspnea on exertion, ECG abnormality (QRS complex abnormal), epistaxis, feeling hot, fever, flu-like symptoms, fungal infection (oral), gastroesophageal reflux disease, increased appetite, increased serum creatinine, insomnia, jitteriness, joint stiffness, limb pain, lower respiratory tract infection, migraine, muscle fatigue, nasal congestion, nasal mucosa irritation, nasopharyngitis, neuralgia, obstructive pulmonary disease, onychomycosis, oral candidiasis, oral discomfort, oropharyngeal pain, pharyngeal erythema, plantar fasciitis, pruritus, rales, retching, rhinorrhea, sinus headache, skin blister, sneezing, strain, sunburn, tendinopathy, throat irritation, tunnel vision, upper abdominal pain, urine discoloration, vulvovaginal infection, weight loss, wheezing
Hypersensitivity to levofloxacin, other quinolones, or any component of the formulation; history of tendinitis or tendon rupture associated with use of any quinolone.
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.
Not available in the US
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Inhalation:
Quinsair: 240 mg/2.4 mL (2.4 mL)
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.
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.
LevoFLOXacin may be confused with levETIRAcetam, levodopa, Levophed, levothyroxine.
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.
Substrate of OAT1/3
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Blood Glucose Lowering Effects: Quinolones may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect 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 therapy
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Amiodarone: Levofloxacin-Containing Products (Systemic) may enhance the QTc-prolonging effect of Amiodarone. Risk X: Avoid combination
Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy
Amphetamines: May enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect 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 diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect 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 combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy
Dabrafenib: QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 therapy
Delamanid: May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 enhance the QTc-prolonging effect of Domperidone. 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
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Fluorouracil Products: QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 therapy
Haloperidol: May enhance the QTc-prolonging effect 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 therapy
Hydroxychloroquine: May enhance the hyperglycemic effect of Levofloxacin-Containing Products (Systemic). Hydroxychloroquine may enhance the hypoglycemic effect of Levofloxacin-Containing Products (Systemic). Hydroxychloroquine may enhance the QTc-prolonging effect of Levofloxacin-Containing Products (Systemic). Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Levoketoconazole: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Levoketoconazole. Risk X: Avoid combination
Methadone: Levofloxacin-Containing Products (Systemic) may enhance the QTc-prolonging effect 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 enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Methylphenidate: May enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy
Mycophenolate: Quinolones may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Risk C: Monitor therapy
Nadifloxacin: May enhance the adverse/toxic effect of Quinolones. Risk X: Avoid combination
Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy
Ondansetron: May enhance the QTc-prolonging effect 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 therapy
Pentamidine (Systemic): May enhance the QTc-prolonging effect 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 therapy
Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Probenecid: May decrease the excretion of Quinolones. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Probenecid may increase the serum concentration of Quinolones. Risk C: Monitor therapy
QT-prolonging Antidepressants (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Antipsychotics (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Class IA Antiarrhythmics (Highest Risk): Levofloxacin-Containing Products (Systemic) may enhance the QTc-prolonging effect of QT-prolonging Class IA Antiarrhythmics (Highest Risk). Risk X: Avoid combination
QT-prolonging Class IC Antiarrhythmics (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Class III Antiarrhythmics (Highest Risk): Levofloxacin-Containing Products (Systemic) may enhance the QTc-prolonging effect of QT-prolonging Class III Antiarrhythmics (Highest Risk). Risk X: Avoid combination
QT-Prolonging Inhalational Anesthetics (Moderate Risk): May enhance the QTc-prolonging effect 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 therapy
QT-prolonging Kinase Inhibitors (Highest Risk): May enhance the QTc-prolonging effect 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 enhance the QTc-prolonging effect 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 therapy
QT-prolonging Miscellaneous Agents (Highest Risk): Levofloxacin-Containing Products (Systemic) may enhance the QTc-prolonging effect 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 enhance the QTc-prolonging effect 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 therapy
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 therapy
QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of other 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 therapy
QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect 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 enhance the QTc-prolonging effect 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 therapy
Sertindole: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect 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
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect 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 enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Quinolones may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
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.
[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.
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.
Inhibition of bacterial DNA gyrase and topoisomerase IV enzymes (both of which are type II topoisomerases) required for DNA replication, transcription, repair and recombination.
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%)
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