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Moxifloxacin (systemic): Pediatric drug information

Moxifloxacin (systemic): Pediatric drug information
(For additional information see "Moxifloxacin (systemic): Drug information" and see "Moxifloxacin (systemic): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Serious adverse reactions:

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.

Myasthenia gravis:

Fluoroquinolones may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis.

Brand Names: US
  • Avelox [DSC]
Brand Names: Canada
  • AG-Moxifloxacin;
  • APO-Moxifloxacin;
  • Auro-Moxifloxacin;
  • Avelox [DSC];
  • BIO-Moxifloxacin;
  • JAMP-Moxifloxacin;
  • M-Moxifloxacin;
  • Mar-Moxifloxacin;
  • Priva-Moxifloxacin [DSC];
  • RIVA-Moxifloxacin [DSC];
  • SANDOZ Moxifloxacin;
  • TEVA-Moxifloxacin
Therapeutic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Respiratory Fluoroquinolone
Dosing: Neonatal

Note: In pediatric patients, fluoroquinolones are not routinely first-line therapy, but after assessment of risks and benefits, can be considered a reasonable alternative for situations where no safe and effective substitute is available (eg, multidrug resistance), or in situations where the only alternative is parenteral therapy and moxifloxacin offers an oral therapy option (AAP [Jackson 2016]).

Anthrax, severe (including meningitis), treatment (AAP [Bradley 2014]): Limited data available: Note: Administer as part of triple therapy, duration 2 to 3 weeks or longer until clinical criteria for stability are met; will require prophylaxis to complete an antimicrobial course of up to 60 days from onset of illness.

GA 32 to 37 weeks, PNA ≤28 days: IV: 5 mg/kg/dose every 24 hours

GA >37 weeks, PNA ≤28 days: IV: 10 mg/kg/dose every 24 hours

Dosing: Pediatric

Note: In pediatric patients, fluoroquinolones are not routinely first-line therapy, but after assessment of risks and benefits, can be considered a reasonable alternative for situations where no safe and effective substitute is available (eg, multidrug resistance) or in situations where the only alternative is parenteral therapy and moxifloxacin offers an oral therapy option (AAP [Jackson 2016]).

Anthrax, systemic (including meningitis), treatment (AAP [Bradley 2014]): Limited data available: Note: Administer as part of triple therapy, duration 2 to 3 weeks or longer until clinical criteria for stability are met; will require prophylaxis to complete an antimicrobial course of up to 60 days from onset of illness.

Infants ≥3 months and Children <2 years: IV: 6 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose

Children 2 to 5 years: IV: 5 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose

Children 6 to 11 years: IV: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose

Children and Adolescents 12 to 17 years:

Body weight <45 kg: IV: 4 mg/kg/dose every 12 hours; maximum dose: 200 mg/dose

Body weight ≥45 kg: IV: 400 mg every 24 hours

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 (IDSA/PIDS [Bradley 2011])

Surgical (perioperative) prophylaxis: Limited data available: Children and Adolescents: IV: 10 mg/kg within 120 minutes prior to surgical incision; maximum dose: 400 mg/dose. Note: While fluoroquinolones have been associated with an increased risk of tendinopathy/tendon rupture in all ages, use of these agents for single-dose prophylaxis is generally safe; not the preferred agent in pediatric patients (ASHP/IDSA/SIS/SHEA [Bratzler 2013]).

Tuberculosis, treatment; multidrug resistant: Limited data available, optimal dose not defined: Note: Use in combination with at least 2 to 3 additional anti-TB agents; regimen and duration vary depending upon susceptibility profile/patterns; consult current TB guidelines for detailed information (ATS/CDC/IDSA [Nahid 2016]; WHO 2014). Recent pharmacokinetic studies suggest that higher doses may be necessary in infants and children to achieve serum concentrations similar to adult standard dosing (Srivastava 2016; Thee 2015).

Infants, Children, and Adolescents <15 years: IV, Oral: 10 mg/kg/dose every 24 hours; maximum dose: 400 mg/dose (ATS/CDC/IDSA [Nahid 2016])

Adolescents ≥15 years: IV, Oral: 400 mg every 24 hours (ATS/CDC/IDSA [Nahid 2016])

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: Pediatric

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).

Dosing: Hepatic Impairment: Pediatric

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.

Dosing: Adult

(For additional information see "Moxifloxacin (systemic): Drug information")

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 (CDC [Bower 2019]).

Note: Anthrax vaccine should also be administered to exposed individuals (CDC [Bower 2019]; CDC [Hendricks 2014]).

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 (CDC [Hendricks 2014]).

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 (CDC [Hendricks 2014]).

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 (CDC [Hendricks 2014]).

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 (IDSA [Stevens 2014]). For prophylaxis, duration is 3 to 5 days (IDSA [Stevens 2014]); for treatment of established infection, duration is typically 5 to 14 days and varies based on clinical response and patient-specific factors (Baddour 2020a; Baddour 2021b).

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 (Sethi 2022).

Oral, IV: 400 mg once daily for 5 to 7 days (GOLD 2021; Wilson 2012).

Diabetic foot infection (alternative agent for patients who cannot receive beta-lactams) (off-label use):

Note: For patients at low risk for Pseudomonas aeruginosa (IDSA [Lipsky 2012]; Weintrob 2020).

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 (IDSA [Lipsky 2012]; Lipsky 2007; Vick-Fragoso 2009; Weintrob 2020).

Endophthalmitis, severe, acute bacterial postcataract (adjunctive agent) (off-label use):

Note: Role of systemic antibiotic administration is not well defined (Durand 2020).

Oral: 400 mg once daily for 5 to 7 days in combination with appropriate intravitreal antibiotics (Durand 2020; ESCRS [Barry 2013]; Hooper 2012).

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 (Barshak 2021). Reserve for patients who are intolerant to both beta-lactams and metronidazole (Pemberton 2021). 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 (SIS [Mazuski 2017]; SIS/IDSA [Solomkin 2010]). For acute diverticulitis, some experts suggest deferring antibiotics in otherwise healthy immunocompetent patients with mild disease; however, data on this approach in outpatients are limited (AGA [Stollman 2015]; Desai 2019; Shah 2017; SIS [Mazuski 2017]; van Dijk 2020).

Oral, IV: 400 mg once daily. Duration of therapy is 4 to 5 days following adequate source control (Sawyer 2015; SIS [Mazuski 2017]); for diverticulitis or uncomplicated appendicitis managed without intervention, duration is 7 to 10 days (Barshak 2021; Pemberton 2021).

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 (Hasbun 2021).

IV: 400 mg once daily as part of an appropriate combination regimen (Hasbun 2021; IDSA [Tunkel 2017]). Treatment duration is 7 to 21 days, depending on causative pathogen(s) and clinical response (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).

Mycoplasma hominis and Ureaplasma extragenital infections: Oral, IV: 400 mg once daily; for patients who are immunocompromised, some experts recommend combination therapy with doxycycline (Hos 2015; Waites 2020; Xiang 2019). Duration of therapy varies depending on disease severity, site of infection, patient immune status, and response to therapy (Waites 2020).

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 (ASCO/IDSA [Taplitz 2018]; Bow 2020; IDSA [Freifeld 2011]).

Oral: 400 mg once daily; continue until fever and neutropenia have resolved (Bow 2020; Kern 2013). Administer first dose in the health care setting (after blood cultures are drawn); observe patient for ≥4 hours before discharge (ASCO/IDSA [Taplitz 2018]; IDSA [Freifeld 2011]).

Plague (Yersinia pestis), treatment:

Note: Consult public health officials for event-specific recommendations.

Oral, IV: 400 mg once daily for 7 to 14 days and at least until 2 days after patient has defervesced (CDC 2020; Stout 2022). Note: Some experts reserve fluoroquinolones for patients who cannot tolerate aminoglycosides or tetracyclines (Stout 2022).

Pneumonia, community-acquired, outpatients with comorbidities and inpatients (alternative agent):

Note: Some experts reserve fluoroquinolones for patients who cannot take other preferred regimens (File 2020). Avoid use in patients with risk factors for P. aeruginosa (ATS/IDSA [Metlay 2019]; File 2020).

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 (ATS/IDSA [Metlay 2019]; File 2020).

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 (AAO-HNS [Rosenfeld 2015]; ACP/CDC [Harris 2016]). Due to risks associated with use, reserve fluoroquinolones for those who have no alternative treatment options (FDA Drug Safety Communication 2016).

Oral: 400 mg once daily for 5 to 7 days (IDSA [Chow 2012]).

Sexually transmitted infections (off-label use):

Mycoplasma genitalium: Oral: 400 mg once daily for 7 days (CDC [Workowski 2021]; Durukan 2020). Some experts recommend preceding this with a course of doxycycline (CDC [Workowski 2021]).

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 (CDC [Workowski 2021]; Wiesenfeld 2021).

Oral: 400 mg once daily in combination with metronidazole for 14 days (CDC [Workowski 2021]).

Skin and soft tissue infections (alternative agent for patients who cannot receive beta-lactams):

Note: Reserve for polymicrobial (including anaerobes) infections (Dryden 2010).

Oral, IV: 400 mg once daily (IDSA [Stevens 2014]; manufacturer’s labeling).

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 (ASHP/IDSA/SIS/SHEA [Bratzler 2013]; Mann 2020).

Tuberculosis (off-label use):

Note: Expert consultation for optimal regimen and duration of treatment is advised.

Drug-susceptible tuberculosis (alternative agent): Oral, IV: 400 mg once daily in combination with additional appropriate antituberculosis agents (ATS/CDC/IDSA [Nahid 2016]).

Drug-resistant tuberculosis: Oral, IV: 400 mg once daily in combination with additional appropriate antituberculosis agents (ATS/CDC/ERS/IDSA [Nahid 2019]); doses of 600 or 800 mg once daily have been used in select cases (eg, elevated minimum inhibitory concentration or malabsorption) (ATS/CDC/ERS/IDSA [Nahid 2019]; Nunn 2019).

Duration: Individualize based on rapidity of culture conversion, extent of disease, and patient-specific factors, including clinical response and toxicity (ATS/CDC/ERS/IDSA [Nahid 2019]; ATS/CDC/IDSA [Nahid 2016]; WHO 2020).

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.

Dosing: Kidney Impairment: Adult

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 (Stass 2002; manufacturer's labeling).

Hemodialysis, intermittent (thrice weekly): Poorly dialyzed: No supplemental dose or dosage adjustment necessary (Stass 2007; Tokimatsu 2017; manufacturer's labeling).

Peritoneal dialysis: Poorly dialyzed: No dosage adjustment necessary (manufacturer's labeling).

CRRT: No dosage adjustment necessary (Fuhrmann 2004).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Czock 2006).

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary; however, use with caution in this patient population secondary to the risk of QT prolongation.

Dosage Forms: US

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:

Avelox: 400 mg [DSC]

Generic: 400 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

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:

Avelox: 400 mg [DSC]

Generic: 400 mg

Medication Guide and/or Vaccine Information Statement (VIS)

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

Administration: Pediatric

IV: Administer using the premix solution (1.6 mg/mL) over 60 minutes; do not infuse by rapid or bolus intravenous infusion. When the same intravenous line is used for sequential infusion of other medications, flush line with NS, D5W, D10W, or 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).

Missed dose: Administer as soon as possible if ≥8 hours until next scheduled dose; otherwise, wait until next scheduled dose.

Administration: Adult

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.

Storage/Stability

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Avoid high humidity. Do not refrigerate infusion solution; discard unused portion.

Use

Treatment of community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, complicated and uncomplicated skin and skin structure infections, complicated intra-abdominal infections, and plague (treatment and prophylaxis) (All indications: FDA approved adults)

Note: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral neuropathy, CNS effects), reserve moxifloxacin use for all patients including pediatric patients (AAP [Jackson 2016]) who have no alternative treatment options (eg, acute exacerbation of chronic bronchitis or acute bacterial sinusitis in adults).

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

Avelox may be confused with Avonex

Adverse Reactions

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

Contraindications

Hypersensitivity to moxifloxacin, other quinolone antibiotics, or any component of the formulation

Warnings/Precautions

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:

• Elderly: 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).

Warnings: Additional Pediatric Considerations

Increased osteochondrosis in immature rats and dogs and arthropathy with erosions of the cartilage in weight-bearing joints of immature animals have been observed with fluoroquinolones; moxifloxacin has caused arthropathy and lameness in immature dogs. Musculoskeletal reactions have been reported in pediatric patients treated with moxifloxacin. In a study of pediatric patients (3 months to <18 years) receiving moxifloxacin for intra-abdominal infections, patients treated with moxifloxacin had a higher incidence of arthralgia compared to those treated with ertapenem/amoxicillin-clavulanate (3% vs 1.3%); most musculoskeletal adverse reactions were reported between 12 and 53 weeks after start of study treatment with complete resolution by the end of the 5-year study period. In a case series of pediatric patients (n=9, age: 6 months to 13 years) receiving moxifloxacin for treatment of pulmonary tuberculosis, one patient (age 6 years) required therapy discontinuation after 3 months due to arthritis of the ankle; symptoms spontaneously resolved a few days later (Garazzino 2014). An erroneously high dose of moxifloxacin resulted in severe acute bilateral polyarthritis in a 12-year old child. The patient received 5 days of 2,000 mg once daily (50 mg/kg/day) resulting in hospital admission, treatment with bed rest, and a course of IV and oral steroids; however, no long-term sequelae or functional impairment was observed during follow-up over the next year (Torres 2008). In pediatric patients, fluoroquinolones are not routinely first-line therapy, but after assessment of risks and benefits, are a reasonable alternative for situations where no safe and effective substitute is available (eg, multidrug resistance) or in situations where the only alternative is parenteral therapy and moxifloxacin offers an oral therapy option (AAP [Jackson 2016]).

Moxifloxacin may cause QT prolongation. Pediatric patients (3 months to <18 years) receiving moxifloxacin for complicated intra-abdominal infections had a higher incidence of QT prolongation (9.3%) when compared to patients receiving ertapenem/amoxicillin-clavulanate (2.7%). Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial ischemia, uncorrected hypokalemia and hypomagnesemia) and drugs that prolong the QT interval.

Metabolism/Transport Effects

None known.

Drug Interactions

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

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

Antacids: May decrease the absorption of Quinolones. Of concern only with oral administration of quinolones. Management: Avoid concurrent administration of quinolones and antacids to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. 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

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

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

Heroin: Quinolones may enhance the adverse/toxic effect of Heroin. 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: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. 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

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

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 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

Sevelamer: May decrease the absorption of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Risk D: Consider therapy modification

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

Food Interactions

Absorption is not affected by administration with a high-fat meal or yogurt.

Dietary Considerations

Avelox IV infusion (premixed in sodium chloride 0.8%) contains sodium 34.2 mEq (~787 mg)/250 mL.

Pregnancy Considerations

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. Active tuberculosis infection 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 tuberculosis in pregnant patients; evidence to support a specific regimen is not available. Based on susceptibility testing, moxifloxacin may be used to treat multidrug-resistant tuberculosis 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).

Monitoring Parameters

WBC, signs of infection, signs and symptoms of tendinopathy, sensory pain (eg, pain, burning, tingling, numbness, weakness, alteration of senses), CNS effects (eg, nervousness, agitation, insomnia, anxiety, dizziness, tremors), ECG in patients with liver cirrhosis

Reference Range

Tuberculosis: Pediatric patients: Peak (2 hours postdose): 3 to 5 mcg/mL (ATS/CDC/IDSA [Nahid 2016])

Mechanism of Action

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.

Pharmacokinetics (Adult data unless noted)

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.

Excretion: Urine (as unchanged drug [20%] and glucuronide conjugates); feces (as unchanged drug [25%] and sulfate conjugates).

Pharmacokinetics: Additional Considerations

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).

Additional Information

Avelox IV infusion (premixed in sodium chloride 0.8%) contains sodium 34.2 mEq (~787 mg)/250 mL.

Extemporaneous Preparations

A 20 mg/mL oral suspension may be made using tablets. Crush three 400 mg tablets and reduce to a fine powder. Carefully sieve powder from enteric-coating remnants to improve pharmaceutical elegance. Add a small amount of a 1:1 mixture of Ora-Plus® and Ora-Sweet® or Ora-Sweet® SF and mix to a uniform paste; mix while adding the vehicle in geometric proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label "shake well". Stable 90 days at room temperature.

Hutchinson DJ, Johnson CE, and Klein KC, "Stability of Extemporaneously Prepared Moxifloxacin Oral Suspensions," Am J Health Syst Pharm, 2009, 66(7):665-7.19299374
Pricing: US

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): $9.26 - $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.

Brand Names: International
  • Avalox (AE, BH, BR, CH, CY, DE, EG, IQ, IR, IT, JO, KW, LB, LY, OM, QA, SA, SY, YE);
  • Avelon (ZA);
  • Avelox (AR, AU, BB, BE, BF, BG, BJ, BM, BS, BZ, CI, CL, CN, CO, CR, CU, CZ, DK, DO, EC, EE, ET, FI, GB, GH, GM, GN, GT, GY, HK, HN, HR, ID, IE, JM, JP, KE, KR, LK, LR, LT, LU, LV, MA, ML, MR, MT, MU, MW, MY, NE, NG, NI, NL, NZ, PA, PE, PH, PK, PL, PR, PY, RO, RU, SC, SD, SE, SG, SK, SL, SN, SR, SV, TH, TN, TR, TT, TZ, UA, UG, UY, VE, VN, ZM);
  • Axa-Moxin (LK);
  • Bacterol (CO);
  • Bancifar (CR, DO, GT, HN, NI, PA, SV);
  • Cubimox (BD);
  • Eftimoxin (VN);
  • Emef (IN);
  • Evaflox (LB);
  • Floxsafe (TZ);
  • Getmoxy (VN);
  • Glomoxif (VN);
  • Idelox (EG);
  • Innolon (ZW);
  • Izilox (FR);
  • M-Flox (ZW);
  • Maxicin (UA);
  • Megaxin (IL);
  • Melvedox (HR);
  • Mofacin (TH);
  • Moflodal (TW);
  • Molox (LK);
  • Moloxcin (VN);
  • Moloxin (HR);
  • Mortapp (EG);
  • Moxaval (EC);
  • Moxicip (ET, ZW);
  • Moxif (IN);
  • Moxiflax (PH);
  • Moxiflo (KR);
  • Moxiflox (BD, PH);
  • Moximac (ET);
  • Moxivig (IE);
  • Oxifled 400 (ZW);
  • Pixiriv (CR, DO, GT, HN, NI, PA, SV);
  • Praxinstad (VN);
  • Proflox (ES, PT);
  • Rivomox (HR);
  • Zigat (PH)


For country abbreviations used in Lexicomp (show table)

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