Version May 2024
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinopathy and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Because fluoroquinolones have been associated with serious adverse reactions, reserve moxifloxacin for use in patients who have no alternative treatment options for the following indications: acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis.
Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis.
Anthrax (off-label use):
Note: Consult public health officials for event-specific recommendations.
Inhalational (postexposure prophylaxis) (alternative agent): Oral: 400 mg once daily; duration depends on anthrax vaccine status and series completion, age, immune status, and pregnancy/breastfeeding status. For those who have not previously received an anthrax vaccine, duration ranges from 42 to 60 days (Ref). Some experts favor longer durations of prophylaxis (eg, total of 3 to 4 months) for patients who are immunocompromised or remain unvaccinated (Ref).
Note: Anthrax vaccine should also be administered to exposed individuals (Ref).
Cutaneous (without systemic involvement), treatment: Oral: 400 mg once daily; duration is 60 days following a biological weapon-related event and 7 to 10 days after naturally acquired infection. Note: Treat patients with extensive edema or cutaneous lesions of the head or neck with a parenteral regimen recommended for systemic involvement (Ref).
Systemic (with or without meningitis), treatment (alternative agent): IV: 400 mg once daily as part of an appropriate combination regimen for ≥2 to 3 weeks or until clinically stable, whichever is longer (Ref).
Note: Antitoxin should also be administered for patients with suspected systemic anthrax. Following the course of IV combination therapy for systemic anthrax infection (including meningitis), patients exposed to aerosolized spores require oral monotherapy to complete a total antimicrobial course of 60 days (Ref).
Bite wound infection, prophylaxis of high-risk bite or treatment (animal or human bite) (alternative agent for patients who cannot receive beta-lactams) (off-label use): Oral, IV: 400 mg once daily (Ref). For prophylaxis, duration is 3 to 5 days (Ref); for treatment of established infection, duration is typically 5 to 14 days and varies based on clinical response and patient-specific factors (Ref).
Chronic obstructive pulmonary disease, acute exacerbation:
Note: Some experts reserve for patients who have risk factors for poor outcomes (eg, ≥65 years of age, FEV1 <50% predicted, frequent exacerbations, major comorbidities), but are at low risk of Pseudomonas infection (Ref).
Oral, IV: 400 mg once daily for 5 to 7 days (Ref).
Diabetic foot infection (alternative agent for patients who cannot receive beta-lactams) (off-label use):
Note: For patients at low risk for Pseudomonas aeruginosa (Ref).
Oral, IV: 400 mg once daily; for moderate to severe infections, use as part of an appropriate combination regimen. Duration of therapy should be tailored to individual clinical circumstances. Most patients with infection limited to skin and soft tissue respond to 1 to 2 weeks of therapy; for infections requiring surgical debridement, duration is usually 2 to 4 weeks in the absence of osteomyelitis (Ref).
Intra-abdominal infection, mild to moderate, community-acquired in patients without risk factors for resistance or treatment failure (alternative agent) :
Note: Some experts avoid moxifloxacin due to high Bacteroides spp. resistance rates (Ref). Reserve for patients who are intolerant to both beta-lactams and metronidazole (Ref). Empiric oral regimens may be appropriate for patients with mild to moderate infection. Other patients may be switched from IV to oral therapy at the same dose when clinically improved and able to tolerate an oral diet (Ref). For acute diverticulitis, some experts suggest deferring antibiotics in otherwise healthy patients who are immunocompetent with mild disease (Ref).
Oral, IV: 400 mg once daily. Duration of therapy is 4 to 5 days following adequate source control (Ref). For diverticulitis or uncomplicated appendicitis managed without intervention, duration is 10 to 14 days (Ref); for perforated appendicitis managed with laparoscopic appendectomy, 2 to 4 days may be sufficient (Ref).
Meningitis, bacterial (alternative agent) (off-label use):
Note: Routine use of fluoroquinolones is not recommended. Reserve for patients with severe allergy that precludes use of beta-lactams or carbapenems, or for resistant organisms (Ref).
IV: 400 mg once daily, often as part of an appropriate combination regimen. Treatment duration is 7 to 21 days, depending on causative pathogen(s) and clinical response (Ref).
Mycoplasma hominis and Ureaplasma extragenital infections: Oral, IV: 400 mg once daily; for patients who are immunocompromised, some experts recommend combination therapy with doxycycline (Ref). Duration of therapy varies depending on disease severity, site of infection, patient immune status, and response to therapy (Ref).
Neutropenic fever, empiric therapy for low-risk patients with cancer (eg, Multinational Association of Supportive Care in Cancer [MASCC] score ≥21) (alternative agent for patients who cannot receive beta-lactams) (off-label use):
Note: Avoid in patients who have received fluoroquinolone prophylaxis (Ref).
Oral: 400 mg once daily; continue until fever and neutropenia have resolved (Ref). Administer first dose in the health care setting (after blood cultures are drawn); observe patient for ≥4 hours before discharge (Ref).
Plague (Y. pestis):
Note: Consult public health officials for event-specific recommendations.
Postexposure prophylaxis: Oral: 400 mg once daily for 7 days (Ref).
Treatment: Oral, IV: 400 mg once daily for 7 to 14 days and for at least a few days after clinical resolution (Ref). For plague meningitis, use as part of an appropriate combination regimen (Ref).
Pneumonia, community-acquired, outpatients with comorbidities and inpatients (alternative agent):
Note: Some experts reserve fluoroquinolones for patients who cannot take other preferred regimens (Ref). Avoid use in patients with risk factors for P. aeruginosa (Ref).
Oral, IV: 400 mg once daily. For inpatients with severe pneumonia or risk factors for methicillin-resistant Staphylococcus aureus, use as part of an appropriate combination regimen. Duration is for a minimum of 5 days; patients should be clinically stable with normal vital signs prior to discontinuation (Ref).
Rhinosinusitis, acute bacterial (alternative agent):
Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients. Reserve antibiotic therapy for poor follow-up or lack of improvement over the observation period (Ref). Due to risks associated with use, reserve fluoroquinolones for those who have no alternative treatment options (Ref).
Oral: 400 mg once daily for 5 to 7 days (Ref).
Sexually transmitted infections (off-label use):
Mycoplasma genitalium: Oral: 400 mg once daily for 7 days (Ref). Some experts recommend preceding this with a course of doxycycline (Ref).
Pelvic inflammatory disease, outpatient therapy, mild to moderate disease (alternative agent): Note: Reserve for patients who cannot use first-line options, are at low risk for fluoroquinolone-resistant Neisseria gonorrhoeae (eg, prevalence is <5% in the location where the infection was acquired), and likely to follow-up (Ref).
Oral: 400 mg once daily for 14 days (Ref).
Surgical prophylaxis (alternative agent for hysterectomy or pelvic reconstruction procedures in patients who cannot receive beta-lactams ) (off-label use): IV: 400 mg within 120 minutes prior to surgical incision in combination with other appropriate antibiotics (Ref).
Tuberculosis (off-label use):
Note: Expert consultation for optimal regimen and duration of treatment is advised.
Drug-susceptible tuberculosis: Oral, IV: 400 mg once daily in combination with additional appropriate antituberculosis agents (Ref).
4-month rifapentine-moxifloxacin-based regimen: Intensive phase: Once daily rifapentine, moxifloxacin, isoniazid, and pyrazinamide for 8 weeks (56 doses), followed by a continuation phase of once daily rifapentine, moxifloxacin, and isoniazid for 9 weeks (63 doses). In the clinical trial, ≥5 doses/week were given by directly observed therapy (Ref). Note: Reserve this regimen for patients ≥40 kg with pulmonary tuberculosis who are not pregnant or breastfeeding; for patients with HIV, only use if CD4 count ≥100 cells/mm3 and in patients on an efavirenz-based antiretroviral regimen (Ref).
Drug-resistant tuberculosis: Oral, IV: 400 mg once daily in combination with additional appropriate antituberculosis agents (Ref); doses of 600 or 800 mg once daily have been used in select cases (eg, elevated minimum inhibitory concentration or malabsorption) (Ref).
Duration: Individualize based on rapidity of culture conversion, extent of disease, and patient-specific factors, including clinical response and toxicity (Ref).
Missed dose: Administer as soon as possible if ≥8 hours until next scheduled dose; otherwise, wait until next scheduled dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).
Hemodialysis, intermittent (thrice weekly): Poorly dialyzed: No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: Poorly dialyzed: No dosage adjustment necessary (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
No dosage adjustment necessary; however, use with caution in this patient population secondary to the risk of QT prolongation.
Refer to adult dosing.
(For additional information see "Moxifloxacin (systemic): Pediatric drug information")
Dosage guidance:
Clinical considerations: Fluoroquinolones should not typically be used as first-line therapy due to their adverse effect profile and risk of development of bacterial resistance. Only use in situations when there is no safe and effective substitute available (eg, drug resistance, allergy) or when oral fluoroquinolone therapy provides a reasonable alternative to parenteral therapy (Ref).
General dosing: Limited data available:
Infants ≥3 months and Children <2 years: Oral, IV: 6 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose (Ref).
Children 2 to <6 years: Oral, IV: 5 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose (Ref).
Children 6 to <12 years: Oral, IV: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose (Ref).
Children ≥12 years and Adolescents <18 years (Ref):
<45 kg: Oral, IV: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
≥45 kg: Oral, IV: 400 mg every 24 hours.
Adolescents ≥18 years: Oral, IV: 400 mg every 24 hours (Ref).
Anthrax, meningitis or disseminated infection when meningitis cannot be ruled out; treatment: Note: Consult public health officials for event-specific recommendations. Administer as part of an appropriate combination regimen for at least 2 to 3 weeks and until patient is clinically stable; treatment must be followed by prophylaxis, for a total antibiotic course of 60 days (Ref).
Infants ≥3 months, Children, and Adolescents <18 years (Ref): Limited data available:
Infants ≥3 months and Children <2 years: IV: 6 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
Children 2 to <6 years: IV: 5 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
Children 6 to <12 years: IV: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
Children ≥12 years and Adolescents <18 years:
<45 kg: IV: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
≥45 kg: IV: 400 mg every 24 hours.
Adolescents ≥18 years: IV: 400 mg every 24 hours (Ref).
Intra-abdominal infection, complicated (alternative agent): Note: Beta-lactam-based regimens are preferred; moxifloxacin may be less effective as compared to beta-lactam comparators (Ref). In clinical trials, patients ≥20 kg received ≥3 days of IV therapy prior to transitioning to oral therapy; patients <20 kg completed course using IV therapy. Total duration of therapy was 5 to 14 days, though a small number of patients received treatment for >14 days (maximum: 24 days) (Ref).
Infants ≥3 months, Children, and Adolescents <18 years (Ref): Limited data available:
Infants ≥3 months and Children <2 years: IV, Oral: 6 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose (Ref).
Children 2 to <6 years: IV, Oral: 5 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
Children 6 to <12 years: IV, Oral: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
Children ≥12 years and Adolescents <18 years:
<45 kg: IV, Oral: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose.
≥45 kg: IV, Oral: 400 mg every 24 hours.
Adolescents ≥18 years: IV, Oral: 400 mg every 24 hours (Ref).
Nontuberculous mycobacterial infection, pulmonary: Limited data available:
Infants, Children, and Adolescents: Oral: 7.5 to 10 mg/kg/dose once daily; maximum dose: 400 mg/dose. Use as part of an appropriate combination regimen until patient is culture negative on therapy for ≥1 year (Ref).
Pneumonia, community-acquired ( M. pneumoniae, C. pneumoniae, C. trachomatis ), mild infection/step-down therapy : Limited data available:
Adolescents with skeletal maturity: Oral: 400 mg once daily (Ref).
Surgical (perioperative) prophylaxis (alternative agent): Limited data available:
Children and Adolescents: IV: 10 mg/kg within 120 minutes prior to surgical incision; maximum dose: 400 mg/dose (Ref).
Tuberculosis, treatment: Limited data available:
Drug-susceptible tuberculosis, pulmonary: Note: Use in combination with rifapentine, isoniazid, and pyrazinamide; see guidelines for regimen details (Ref).
Children ≥12 years and Adolescents, weighing ≥40 kg: Oral: 400 mg once daily for 17 weeks (119 total doses) (Ref).
Drug-resistant tuberculosis : Note: Use as part of an appropriate combination regimen; consult current guidelines for detailed information (Ref). Pharmacokinetic studies suggest that higher doses may be necessary in pediatric patients to achieve target concentrations, but doses higher than 15 mg/kg/dose every 24 hours require further evaluation (Ref).
Infants, Children, and Adolescents: Oral, IV: 10 to 15 mg/kg/dose every 24 hours; usual maximum dose: 400 mg/dose; higher maximum doses (600 or 800 mg) may be used with higher minimum inhibitory concentrations (MICs) or in cases of malabsorption (Ref). Duration of therapy should be individualized based on patient-specific factors (eg, extent of disease, rapidity of culture conversion, clinical response, and toxicity) (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents: There are no pediatric specific recommendations. Based on experience in adult patients, no dosage adjustment necessary. Poorly dialyzed (<10%); no supplemental dose or dosage adjustment necessary, including patients on intermittent hemodialysis, peritoneal dialysis, or continuous renal replacement therapy (eg, CVVHD).
Infants, Children, and Adolescents: There are no pediatric specific recommendations. Based on experience in adult patients, no dosage adjustment necessary; however, use with caution; metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache (4%), dizziness (3%), insomnia (2%)
Endocrine & metabolic: Decreased serum glucose (≥2%), hyperchloremia (≥2%), increased serum albumin (≥2%), hypokalemia (1%)
Gastrointestinal: Nausea (7%), diarrhea (6%), decreased amylase (≥2%), constipation (2%), vomiting (2%), abdominal pain (1% to 2%), dyspepsia (1%)
Hematologic & oncologic: Decreased basophils (≥2%), decreased red blood cells (≥2%), eosinopenia (≥2%), increased MCH (≥2%), increased neutrophils (≥2%), leukocytosis (≥2%), prolonged prothrombin time (≥2%), anemia (1%)
Hepatic: Decreased serum bilirubin (≥2%), increased serum bilirubin (≥2%), increased serum alanine aminotransferase (1%)
Immunologic: Increased serum globulins (≥2%)
Renal: Increased ionized serum calcium (≥2%)
Respiratory: Hypoxia (≥2%)
Miscellaneous: Fever (1%)
<1%, postmarketing, and/or case reports: Abdominal distention, abdominal distress, abnormal gait, abnormal hepatic function tests, agitation, agranulocytosis, allergic dermatitis, anaphylactic shock, anaphylaxis, angina pectoris, angioedema, anorexia, anxiety, aplastic anemia, arthralgia, asthenia, asthma, ataxia, atrial fibrillation, auditory impairment, back pain, blurred vision, bradycardia, bronchospasm, candidiasis, cardiac failure, chest discomfort, chest pain, chills, cholestatic hepatitis, Clostridioides difficile associated diarrhea, Clostridioides difficile colitis, confusion, deafness, decreased appetite, dehydration, delirium, depression, disorientation, disturbance in attention, drowsiness, dysesthesia, dysgeusia, dyspnea, dysuria, edema, eosinophilia, erythema of skin, exacerbation of myasthenia gravis, facial edema, facial pain, fatigue, flatulence, fungal infection, gastritis, gastroenteritis, gastroesophageal reflux disease, hallucination, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2014), hyperglycemia, hyperhidrosis, hyperlipidemia, hypersensitivity pneumonitis, hypersensitivity reaction, hypertension, hypoesthesia, hypoglycemia, hypotension, idiopathic intracranial hypertension, increased amylase, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased intracranial pressure, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum creatinine, increased serum lipase, increased serum triglycerides, increased uric acid, interstitial nephritis, jaundice, laryngeal edema, lethargy, leukopenia, limb pain, loss of consciousness, malaise, memory impairment, muscle spasm, musculoskeletal pain, myalgia, myasthenia, nervousness, neutropenia, nightmares, night sweats, pain, palpitations, pancytopenia, paranoid ideation, paresthesia, peripheral neuropathy (may be irreversible), pharyngeal edema, phlebitis, phototoxicity, polyneuropathy, prolonged partial thromboplastin time, prolonged QT interval on ECG, pruritus, renal failure syndrome, renal insufficiency, restlessness, rupture of tendon, seizure, serum sickness, skin photosensitivity, skin rash, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, syncope, tachycardia, tendinopathy, thrombocythemia, thrombocytopenia, thrombotic thrombocytopenic purpura, tingling sensation, tinnitus, torsades de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, urticaria, vaginal infection, vasculitis, ventricular tachyarrhythmia, vertigo, vision loss, vulvovaginal pruritus, wheezing, xerostomia
Hypersensitivity to moxifloxacin, other quinolone antibiotics, or any component of the formulation
Concerns related to adverse effects:
• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with known QTc prolongation, ventricular arrhythmias including torsades de pointes, proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial ischemia), uncorrected hypokalemia, hypomagnesemia, 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 aortic aneurysm ruptures or dissection within 2 months following use, particularly in elderly patients. Fluoroquinolones should not be used in patients with a known history of aortic aneurysm or those at increased risk, including patients with peripheral atherosclerotic vascular diseases, hypertension, genetic disorders involving blood vessel changes (eg, Marfan syndrome, Ehlers-Danlos syndrome), and elderly patients, unless no other treatment options are available. Longer treatment duration (eg, >14 days) may increase risk (Lee 2018).
• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose regulation, including hyperglycemia and hypoglycemia. These events have occurred most often in elderly patients or patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases of hypoglycemia, including coma and death, have been reported. Diabetic patients should be monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if a hypoglycemic reaction occurs and immediately initiate appropriate therapy.
• Hepatotoxicity: Fulminant hepatitis potentially leading to liver failure (including fatalities) has been reported with use; patients should be advised to discontinue treatment and promptly report signs/ symptoms of hepatitis (eg, abdominal pain, jaundice, dark urine, pale stools).
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. 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.
• Photosensitivity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may rarely cause moderate to severe phototoxicity reactions. Discontinue use if phototoxicity occurs.
• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinopathy and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue moxifloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without pre-existing risk factors have experienced these reactions; may occur within hours to weeks after initiation.
- CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), lightheadedness, dizziness, and tremors. May occur following the first dose; discontinue immediately and avoid further use of fluoroquinolones in patients who experience these reactions. Use with caution in patients with known or suspected CNS disorder, or risk factors that may predispose to seizures or lower the seizure threshold.
- Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy.
- Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of psychiatric reactions, including toxic psychosis, hallucinations, or paranoia; may also cause nervousness, agitation, delirium, attention disturbances, insomnia, anxiety, nightmares, memory impairment, confusion, depression, and suicidal thoughts or actions. Use with caution in patients with a history of or risk factor for depression. Reactions may occur following the first dose; discontinue if reaction occurs and institute appropriate therapy.
- Tendinopathy/tendon rupture: Fluoroquinolones have been associated with an increased risk of tendinopathy and tendon rupture in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant recipients, and in patients >60 years of age, but has also occurred in patients without these risk factors. Rupture of the Achilles tendon has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Inflammation and rupture may occur bilaterally. Cases have been reported within hours or days of initiation, and up to several months after discontinuation of therapy. Strenuous physical activity, renal failure, and previous tendon disorders may be independent risk factor for tendon rupture. Discontinue at first sign of tendon pain, swelling, inflammation or rupture. Avoid use in patients with a history of tendon disorders or who have experienced tendinopathy or tendon rupture.
• 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.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with significant bradycardia or acute myocardial ischemia.
• Diabetes: Use with caution in patients with diabetes mellitus; glucose regulation may be altered.
• Hepatic impairment: Use with caution in patients with mild, moderate, or severe hepatic impairment or liver cirrhosis; may increase the risk of QT prolongation.
• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with known history of 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 failure; 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, tendon rupture, QT changes) may be increased in elderly patients.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with fluoroquinolone use in patients with G6PD deficiency (Luzzatto 2020).
• Pediatric: Efficacy of systemically administered moxifloxacin (oral, intravenous) have not been established in pediatric patients.
Other warnings/precautions:
• Appropriate use: [US Boxed Warning]: Reserve use of moxifloxacin for treatment of acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis for patients who have no alternative treatment options because of the risk of disabling and potentially serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral neuropathy, CNS effects).
Arthropathy, or joint disease, has been observed in both animal and pediatric human studies following treatment with fluoroquinolone antibiotics, including moxifloxacin (Garazzino 2014; Patel 2016; Wirth 2018; manufacturer's labeling). In a randomized, double-blind study of pediatric patients (3 months to 17 years) receiving moxifloxacin for complicated intra-abdominal infection, a slightly higher incidence of musculoskeletal adverse events (including arthralgia) was observed in patients treated with moxifloxacin (4.3%; n=13/301) versus ertapenem and amoxicillin/clavulanate (3.3%; n=5/150). Arthralgia occurred in 9 (3%) moxifloxacin-treated patients and 1 (1.3%) ertapenem and amoxicillin/clavulanate-treated patient. None of the musculoskeletal adverse effects were considered to be related to either study medication; most events were mild and occurred 3 weeks to 1 year after receipt of medication, and all resolved by the end of the 5-year follow-up period (Wirth 2018; manufacturer's labeling). Arthropathy and arthralgias appear to resolve after discontinuation of treatment, with no long-term sequelae (Garazzino 2014; Patel 2016; Torres 2008; Wirth 2018). Though the true incidence is unknown, arthropathy and arthralgia are considered to be infrequent but potentially serious adverse reactions; higher doses and prolonged exposure likely increase risk (AAP [Jackson 2016]; Garazzino 2014; Patel 2016; Torres 2008).
Moxifloxacin may cause QT prolongation. In a double-blind, randomized trial, pediatric patients (age 3 months to <18 years) receiving moxifloxacin for complicated intra-abdominal infections for a mean of 6.2 days IV and 4.4 days orally had a higher incidence of QT prolongation (overall: 9.3%; n=28/301; considered drug-related: 7%; n=21/301) when compared to patients receiving ertapenem and amoxicillin/clavulanate (2.7%; n=4/150; considered drug-related: 1.3%, n=2/150) (Wirth 2018). In a retrospective evaluation of 220 pediatric patients (age 8.5 months to 17.9 years) who received 300 courses of moxifloxacin (mean dose: <40 kg: ~10 mg/kg; ≥40 kg: ~400 mg), ECG was performed during therapy in 85 courses. QTc prolongation was noted in 29 courses, with 18 (6%) attributed to moxifloxacin, occurring at a mean of 11 days (range: 1 to 62 days) after initiation. In 10 of the courses with QTc prolongation, moxifloxacin was used with concomitant QTc-prolonging agents (Dixit 2018). No cardiac events or clinical sequelae were reported in either study (Dixit 2018; Wirth 2018). Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial ischemia), or uncorrected hypokalemia and hypomagnesemia, and in patients concomitantly receiving drugs that prolong the QT interval (manufacturer's labeling).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous [preservative free]:
Avelox: 400 mg/250 mL (250 mL [DSC])
Generic: 400 mg/250 mL (250 mL)
Tablet, Oral:
Generic: 400 mg
Yes
Solution (Moxifloxacin HCl in NaCl Intravenous)
400 mg/250 mL (per mL): $0.22
Solution (Moxifloxacin HCl Intravenous)
400 mg/250 mL (per mL): $0.22
Tablets (Moxifloxacin HCl Oral)
400 mg (per each): $27.19 - $27.23
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Avelox: 400-0.8 MG/250ML-% ([DSC])
Generic: 400 mg/250 mL (250 mL)
Tablet, Oral:
Generic: 400 mg
Oral: Administer without regard to meals. Administer at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron, or zinc, including antacids, sucralfate, multivitamins, and didanosine (buffered tablets for oral suspension or the pediatric powder for oral solution).
IV: Infuse over 60 minutes; do not infuse by rapid or bolus intravenous infusion.
IV: Administer using the premix solution (1.6 mg/mL) over 60 minutes; do not infuse by rapid or bolus IV infusion (Ref). When the same IV line is used for sequential infusion of other medications, flush line with a compatible solution (eg, NS, D5W, D10W, LR) before and after infusing moxifloxacin.
Oral: Administer without regard to meals. Administer 4 hours before or 8 hours after products containing magnesium, aluminum, iron, or zinc, including antacids, sucralfate, multivitamins, and didanosine (buffered tablets for oral suspension or the pediatric powder for oral solution). Tablets may be crushed and suspended in water for immediate administration; however, crushed tablets have a bitter taste and may not be tolerated (Ref).
Missed dose: Administer as soon as possible if ≥8 hours until next scheduled dose; otherwise, wait until next scheduled dose.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Avelox: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066,021277s062lbl.pdf#page=33
Moxifloxacin IV solution: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205572s006lbl.pdf#page=49
Treatment of mild to moderate community-acquired pneumonia, including multidrug-resistant Streptococcus pneumoniae (MDRSP); acute bacterial exacerbation of chronic bronchitis; acute bacterial rhinosinusitis; complicated and uncomplicated skin and skin structure infections; complicated intra-abdominal infections; prophylaxis and treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis.
Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral neuropathy, CNS effects), reserve use of moxifloxacin for acute exacerbation of chronic bronchitis or acute sinusitis for patients who have no alternative treatment options.
Anthrax; Bite wound infection, prophylaxis of high-risk bite or treatment (animal or human bite); Diabetic foot infection; Meningitis, bacterial; Mycoplasma genitalium; Neutropenic fever, empiric therapy for low-risk patients with cancer; Pelvic inflammatory disease; Surgical prophylaxis; Tuberculosis, drug resistant; Tuberculosis, drug susceptible
Avelox may be confused with Avonex
None known.
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
Aluminum Hydroxide: May decrease the absorption of Moxifloxacin (Systemic). Management: Administer moxifloxacin at least 4 hours before or 8 hours after aluminum hydroxide. Risk D: Consider therapy modification
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
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
Charcoal, Activated: May decrease the serum concentration of Moxifloxacin (Systemic). 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
Didanosine: Quinolones may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. 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 Moxifloxacin (Systemic). Hydroxychloroquine may enhance the hypoglycemic effect of Moxifloxacin (Systemic). Hydroxychloroquine may enhance the QTc-prolonging effect of Moxifloxacin (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
Iron Preparations: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider therapy modification
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Lanthanum: May decrease the serum concentration of Quinolones. Management: Administer oral quinolone antibiotics at least one hour before or four hours after lanthanum. Risk D: Consider therapy modification
Levoketoconazole: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Levoketoconazole. Risk X: Avoid combination
Magnesium Salts: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar/enox-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe/enox-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Risk D: Consider therapy modification
Mequitazine: Moxifloxacin (Systemic) may enhance the arrhythmogenic effect of Mequitazine. Risk X: Avoid combination
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
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolones. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased quinolone efficacy. Risk D: Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolones. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased therapeutic effects of quinolones. Risk D: Consider therapy modification
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
Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Quinolones. Management: Give oral quinolones at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Moxifloxacin (Systemic). Risk X: Avoid combination
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 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 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 (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 (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 (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
RifAMPin: May decrease the serum concentration of Moxifloxacin (Systemic). 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
Strontium Ranelate: May decrease the serum concentration of Quinolones. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Risk X: Avoid combination
Sucralfate: May decrease the serum concentration of Quinolones. Management: Avoid concurrent administration of quinolones and sucralfate to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. 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
Zinc Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Risk D: Consider therapy modification
Absorption is not affected by administration with a high-fat meal or yogurt.
Moxifloxacin crosses the placenta (Ozyüncü 2010a; Ozyüncü 2010b).
Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of moxifloxacin may be altered. Dose adjustment was not needed in 1 woman treated with moxifloxacin for multidrug-resistant tuberculosis (Nemutlu 2010; van Kampenhout 2017).
Moxifloxacin is used off label for the treatment of drug-resistant tuberculosis. Tuberculosis (TB) disease (active TB) is associated with adverse fetal outcomes, including intrauterine growth restriction, low birth weight, preterm birth, and perinatal death (Esmail 2018; Miele 2020), as well as adverse maternal outcomes, including increased risks for anemia and cesarean delivery. Placental transmission may rarely occur with active maternal disease (Miele 2020). Data are limited for use of second-line drugs in pregnancy (ie, fluroquinolones). Individualized regimens should be utilized to treat multidrug-resistant TB in pregnant patients; evidence to support a specific regimen is not available. Based on susceptibility testing, moxifloxacin may be used to treat multidrug-resistant TB during pregnancy when needed (ATS/CDC/ERS/IDSA [Nahid 2019]; HHS [OI adult 2020]; WHO 2020).
Moxifloxacin is used off-label to reduce the incidence or disease progression of inhalational anthrax (postexposure). Untreated anthrax infection during pregnancy is associated with preterm labor, fetal distress, and fetal loss. However, moxifloxacin is not the preferred fluoroquinolone for the prophylaxis or treatment of anthrax in pregnant and postpartum patients (Meaney-Delman 2014).
Untreated plague (Y. pestis) infection in pregnant patients may result in hemorrhage (including postpartum hemorrhage), maternal and fetal death, preterm birth, and stillbirth. Limited data suggest maternal-fetal transmission of Y. pestis can occur if not treated. Pregnant patients should be treated for Y. pestis; parenteral antibiotics are preferred for initial treatment when otherwise appropriate. Moxifloxacin is an alternative fluoroquinolone recommended for use (in combination with an aminoglycoside) for treating pregnant patients with bubonic, pharyngeal, pneumonic, or septicemic plague. Recommendations for treating pregnant patients with plague meningitis are the same as in nonpregnant patients. Moxifloxacin may also be used as an alternative antibiotic for pre- and postexposure prophylaxis in pregnant patients exposed to Y. pestis (CDC [Nelson 2021]).
It is not known if moxifloxacin is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Use of fluoroquinolone antibiotics should be avoided if alternative agents are available (WHO 2002).
Premixed in freeflex bags contains sodium ~52.5 mEq (~1,207 mg)/250 mL.
Premixed in sodium chloride 0.8% contains sodium ~34.2 mEq (~787 mg)/250 mL.
WBC, signs of infection, signs/symptoms of disordered glucose regulation, ECG in patients with liver cirrhosis
Moxifloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; inhibition is bactericidal.
Absorption: Well absorbed; not affected by high-fat meal or yogurt.
Distribution: Tissue concentrations often exceed plasma concentrations in respiratory tissues, alveolar macrophages, abdominal tissues/fluids, uterine tissue (endometrium, myometrium), and sinus tissues.
Vd:
Infants >3 months of age, children, and adolescents ≤13 years of age: ~1.5 to 2.3 L/kg (Stass 2019).
Adults: 1.7 to 2.7 L/kg.
Protein binding: ~30% to 50%.
Metabolism: Hepatic (~52% of dose) via glucuronide (~14%) and sulfate (~38%) conjugation.
Bioavailability: ~90%.
Half-life elimination:
Pediatric patients: Single dose: IV:
Infants >3 months of age and children <2 years of age: IV: ~5.9 to 6.8 hours (Stass 2019).
Children ≥2 to <6 years of age: ~5.7 to 6 hours (Stass 2019).
Children ≥6 years of age and adolescents ≤13 years of age: ~6.2 to 7.9 hours (Stass 2019).
Adults: Single dose: Oral: ~11.5 to 15.6 hours; IV: 8.2 to 15.4 hours.
Time to peak: Children ≥7 years and adolescents ≤15 years: Whole tablet: Median: 3 hours (range: 1 to 8 hours); Crushed tablet: Median: 1 hour (range: 1 to 2 hours) (Thee 2015).
Excretion: Urine (as unchanged drug [20%] and glucuronide conjugates); feces (as unchanged drug [25%] and sulfate conjugates).
Anti-infective considerations:
Parameters associated with efficacy:
Concentration dependent: Associated with AUC24/minimum inhibitory concentration (MIC) and Cmax (peak)/MIC.
Pathogen specific:
Gram negative organisms: AUC24/MIC ≥100 to 125 (Abdul-Aziz 2020; Odenholt 2006; Rodvold 2001) or Cmax/MIC ≥10 (Odenholt 2006; Rodvold 2001).
S. pneumoniae: AUC24/MIC ≥30 (bactericidal) (Ambrose 2001; Garrison 2003; Lacy 1999; Lister 1999).
Expected drug exposure in patients with normal renal function:
AUC24:
IV:
Pediatric patients with suspected or proven infection, single dose (geometric mean):
Infants >3 months of age and children <2 years of age: 9 mg/kg: 25.5 mg•hour/L (Stass 2019).
Children ≥2 to <6 years of age: 7 mg/kg: 28.2 mg•hour/L (Stass 2019).
Children ≥6 years of age and adolescents ≤13 years of age: 5 mg/kg: 19.7 mg•hour/L (Stass 2019).
Adults: 400 mg once daily, multiple dose: 38 ± 4.7 mg•hour/L.
Oral:
Children and adolescents 7 to 15 years of age: 10 mg/kg, steady state: median 23.3 mg•hour/L (range 19.2 to 42.3 mg•hour/L) (Thee 2015).
Adults: 400 mg once daily, multiple dose: 48 ± 2.7 mg•hour/L.
Cmax (peak):
IV:
Pediatric patients with suspected or proven infection, single dose (geometric mean):
Infants >3 months of age and children <2 years of age: 9 mg/kg: 5.3 mg/L (Stass 2019).
Children ≥2 to <6 years of age: 7 mg/kg: 6.5 mg/L (Stass 2019).
Children ≥6 years of age and adolescents ≤13 years of age: 5 mg/kg: 3.2 mg/L (Stass 2019).
Adults: 400 mg once daily, multiple dose: 4.2± 0.8 mg/L.
Oral:
Children and adolescents 7 to 15 years of age: 10 mg/kg, steady state: median 3.08 mg/L (range: 2.85 to 3.82 mg/L) (Thee 2015).
Adults: 400 mg once daily, multiple dose: 4.5 ± 0.5 mg/L.
Postantibiotic effect: Bacterial killing continues after moxifloxacin concentration falls below the MIC of targeted pathogen and varies based on the organism; generally, 1 to 3 hours (Boswell 1999).
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