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Generic Name: Moxifloxacin Hydrochloride
Class: Quinolones
VA Class: AM900
Chemical Name: (4aS - cis) - 1 - Cyclopropyl - 6 - fluoro - 1,4 - dihydro - 8 - methoxy - 7 - (octahydro - 6H - pyrrolol[3,4 - b]pyridin - 6 - yl) - 4 - oxo - 3 - quinolinecarboxylic acid monohydrochloride
Molecular Formula: C21H24FN3O4
CAS Number: 186826-86-8

Warning(s)

  • Systemic fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.1 128 129 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 128 129 (See Tendinopathy and Tendon Rupture under Cautions.)

  • Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.1 Avoid in patients with known history of myasthenia gravis.1

Introduction

Antibacterial; 8-methoxy fluoroquinolone.1 2

Uses for Avelox

Respiratory Tract Infections

Treatment of acute bacterial sinusitis caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.1

Treatment of acute bacterial exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae, H. parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or M. catarrhalis.1

Treatment of community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (including multidrug-resistant strains), S. aureus (oxacillin-susceptible [methicillin-susceptible] strains), K. pneumoniae, H. influenzae, M. catarrhalis, Mycoplasma pneumoniae, or Chlamydophila pneumoniae (formerly Chlamydia pneumoniae).1 31 53

Select regimen for empiric treatment of CAP based on most likely pathogens and local susceptibility patterns; after pathogen is identified, modify to provide more specific therapy (pathogen-directed therapy).31 Do not use a fluoroquinolone alone for empiric treatment of CAP in patients requiring treatment in an intensive care unit (ICU).31

For empiric outpatient treatment of CAP in previously healthy adults without risk factors for drug-resistant S. pneumoniae (DRSP), IDSA and ATS recommend monotherapy with a macrolide (azithromycin, clarithromycin, erythromycin) or, alternatively, doxycycline.31 If risk factors for DRSP are present (e.g., chronic heart, lung, liver, or renal disease, diabetes mellitus, alcoholism, malignancy, asplenia, immunosuppression, history of anti-infective treatment within the last 3 months), IDSA and ATS recommend monotherapy with a fluoroquinolone with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) or, alternatively, a combination regimen that includes a β-lactam active against S. pneumoniae (high-dose amoxicillin or fixed combination of amoxicillin and clavulanic acid or, alternatively, ceftriaxone, cefpodoxime, or cefuroxime) given in conjunction with a macrolide or doxycycline.31

For empiric inpatient treatment of CAP in non-ICU patients, IDSA and ATS recommend adults receive monotherapy with a fluoroquinolone with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) or, alternatively, a combination regimen that includes a β-lactam (usually cefotaxime, ceftriaxone, or ampicillin) given in conjunction with a macrolide (azithromycin, clarithromycin, erythromycin) or doxycycline.31 For empiric inpatient treatment of CAP in ICU patients when Pseudomonas and oxacillin-resistant (methicillin-resistant) Staphylococcus aureus are not suspected, IDSA and ATS recommend a combination regimen that includes a β-lactam (cefotaxime, ceftriaxone, fixed combination of ampicillin and sulbactam) given in conjunction with either azithromycin or a fluoroquinolone (gemifloxacin, levofloxacin, moxifloxacin).31

Treatment of nosocomial pneumonia, including hospital-acquired, ventilator-associated, and healthcare-associated pneumonia.51 Use local susceptibility data when selecting an empiric regimen.50 51

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Skin and Skin Structure Infections

Treatment of uncomplicated skin and skin structure infections (abscesses, furuncles, cellulitis, impetigo) caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains) or S. pyogenes (group A β-hemolytic streptococci).1 13 43

Treatment of complicated skin and skin structure infections caused by susceptible S. aureus (oxacillin-susceptible strains), Escherichia coli, K. pneumoniae, or Enterobacter cloacae.1 43 44

Intra-abdominal Infections

Treatment of complicated intra-abdominal infections (including polymicrobial infections such as abscess) caused by susceptible Bacteroides fragilis, B. thetaiotaomicron, Clostridium perfringens, Enterococcus faecalis, E. coli, Proteus mirabilis, S. anginosus, S. constellatus, or Peptostreptococcus.1 32 39

For initial empiric treatment of mild to moderate community-acquired, extrabiliary, complicated intra-abdominal infections in adults (e.g., perforated or abscessed appendicitis), IDSA recommends either monotherapy with cefoxitin, ertapenem, moxifloxacin, tigecycline, or the fixed combination of ticarcillin and clavulanic acid, or a combination regimen that includes either a cephalosporin (cefazolin, ceftriaxone, cefotaxime, cefuroxime) or fluoroquinolone (ciprofloxacin, levofloxacin) in conjunction with metronidazole.39

Consult current IDSA clinical practice guidelines at for additional information regarding management of intra-abdominal infections.39

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).35 AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,35 but a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered when β-lactam anti-infectives cannot be used.35 Consultation with an infectious disease specialist is recommended.35

GI Infections

Alternative for treatment of >Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults.412 CDC, NIH, and IDSA recommend ciprofloxacin as drug of choice; other fluoroquinolones (levofloxacin, moxifloxacin) also may be effective.412 Depending on in vitro susceptibility, other alternatives are co-trimoxazole and third generation cephalosporins (ceftriaxone, cefotaxime).412 Role of long-term anti-infective treatment (secondary prophylaxis) in HIV-infected individuals with recurrent bacteremia not well established; weigh benefits of such prophylaxis against risks of long-term anti-infective therapy.412

Treatment of shigellosis caused by susceptible Shigella when anti-infectives indicated.412 477 Anti-infectives generally indicated in addition to fluid and electrolyte replacement for treatment of patients with severe shigellosis, dysentery, or underlying immunosuppression.292 412 Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common.292 Fluoroquinolones (e.g., ciprofloxacin, levofloxacin, moxifloxacin) are drugs of choice when susceptibility of the isolate is unknown or ampicillin- or co-trimoxazole-resistant strains are involved.292 412 477

Anthrax

Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax) when oral ciprofloxacin and oral doxycycline are unavailable.14

Alternative for treatment of inhalational anthrax when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).14 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for initial treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.14 16 37

Meningitis and CNS Infections

Alternative for treatment of meningitis caused by susceptible gram-positive bacteria (e.g., S. pneumoniae) or gram-negative bacteria (e.g., Neisseria meningitidis, H. influenzae, E. coli).47

Safety and efficacy not established for CNS infections.47 Limited data from animal studies indicate moxifloxacin has been effective for treatment of experimental meningitis caused by S. pneumoniae or E. coli.48 49 Fluoroquinolones (ciprofloxacin, moxifloxacin) should be considered for treatment of meningitis only when the infection is caused by multidrug-resistant gram-negative bacilli or when the usually recommended anti-infectives cannot be used or have been ineffective.47

Tuberculosis

Alternative for use in multiple-drug regimens for treatment of active tuberculosis.40

Has been used in multiple-drug regimens for treatment of disseminated infections caused by Mycobacterium avium complex (MAC).412

CDC, ATS, and IDSA state that use of fluoroquinolones can be considered in patients with relapse, treatment failure, or M. tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.40 There have been recent reports of extensively drug-resistant tuberculosis (XDR tuberculosis).64 72 XDR tuberculosis is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin).64 72

Although there is clinical experience with several fluoroquinolones in the treatment of tuberculosis (e.g., ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin),40 61 65 85 levofloxacin and moxifloxacin are the fluoroquinolones recommended by CDC, ATS, and IDSA and levofloxacin may be preferred on the basis of cumulative experience.40

ATS and IDSA state that role of fluoroquinolones in treatment of MAC infections not established.671 If a fluoroquinolone is included in treatment regimen (e.g., for macrolide-resistant MAC infections), moxifloxacin or levofloxacin may be preferred,412 671 although many strains are resistant in vitro.671

Consult most recent CDC, ATS, and IDSA recommendations for treatment of tuberculosis and other mycobacterial infections for more specific information.40 412 671

Other Mycobacterial Infections

Treatment of M. kansasii infections in conjunction with other antimycobacterials.671 ATS and IDSA recommend a multiple-drug regimen of isoniazid, rifampin, and ethambutol for treatment of pulmonary or disseminated infections caused by M. kansasii.671 If rifampin-resistant M. kansasii are involved, ATS and IDSA recommend a 3-drug regimen based on results of in vitro susceptibility testing, including clarithromycin (or azithromycin), moxifloxacin, ethambutol, sulfamethoxazole, or streptomycin.671

Role of fluoroquinolones in treatment of M. avium complex (MAC) infections has not been established.671 Moxifloxacin may be preferred if a fluoroquinolone is used in conjunction with other antimycobacterial anti-infectives for the treatment of MAC infections, but many strains are resistant in vitro.671 Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.671

Avelox Dosage and Administration

Administration

Administer orally or by slow IV infusion.1 Do not give IM, sub-Q, intrathecally, or intraperitoneally.1

IV route indicated in patients unable to tolerate the drug orally and in other patients when IV route offers a clinical advantage.1 If IV route is used initially, switch to oral route when clinically indicated.1

Patients receiving oral or IV moxifloxacin should be well hydrated and should be instructed to drink fluids liberally.1

Oral Administration

Administer orally without regard to meals.1 (See Pharmacokinetics.)

IV Infusion

Premixed injection for IV infusion containing 400 mg of moxifloxacin in 0.8% sodium chloride injection may be used without further dilution.1

Premixed injection for IV infusion does not contain preservatives; discard any unused portions.1

Additives or other drugs should not be infused simultaneously through the same IV line.1

For solution and drug compatibility information, see Compatibility under Stability.

Rate of Administration

Administer by IV infusion over 1 hour.1 Avoid rapid IV infusion.1

Dosage

Available as moxifloxacin hydrochloride; dosage expressed in terms of moxifloxacin.1

Dosage of oral and IV moxifloxacin is identical.1 Dosage adjustment not needed when switching from IV to oral administration, or vice versa.1

Adults

Respiratory Tract Infections
Acute Bacterial Sinusitis
Oral or IV

400 mg once daily for 10 days.1

Acute Bacterial Exacerbations of Chronic Bronchitis
Oral or IV

400 mg once daily for 5 days.1

Community-acquired Pneumonia (CAP)
Oral or IV

400 mg once daily for 7–14 days.1 IDSA and ATS state that CAP should be treated for a minimum of 5 days and patients should be afebrile for 48–72 hours before discontinuing anti-infective therapy.31

Skin and Skin Structure Infections
Uncomplicated Infections
Oral or IV

400 mg once daily for 7 days.1

Complicated Infections
Oral or IV

400 mg once daily for 7–21 days.1

Intra-abdominal Infections
Complicated Infections
IV, then Oral

Initiate therapy with 400 mg IV once daily.1 39 When appropriate, switch to oral moxifloxacin 400 mg once daily.1

Manufacturer recommends total duration of therapy of 5–14 days.1 IDSA recommends treatment duration of 4–7 days; longer duration not associated with improved outcome and not recommended unless adequate source control is difficult to achieve.39

GI Infections
Salmonella Gastroenteritis
Oral

HIV-infected: 400 mg once daily.412

Recommended duration is 7–14 days if CD4+ T-cells ≥200 cells/mm3 (≥14 days if bacteremic or infection is complicated) or 2–6 weeks if CD4+ T-cells <200 cells/mm3.412

Role of long-term treatment (secondary prophylaxis) in those with recurrent bacteremia not well established; weigh benefits against risks of long-term anti-infective exposure.412 Consider secondary prophylaxis in those with CD4+ T-cells <200 cells/mm3 and severe diarrhea.412

IV

HIV-infected: 400 mg once daily.412

Shigella Infections
Oral

HIV-infected: 400 mg once daily.412

Recommended duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections.412 Up to 6 weeks may be required for recurrent infections, especially if CD4+ T-cells <200 cells/mm3.412

IV

HIV-infected: 400 mg once daily.412

Anthrax
Postexposure Prophylaxis Following Exposure in the Context of Biologic Warfare or Bioterrorism
Oral

400 mg once daily14 for ≥60 days.14 15 37 45 46

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear, but prolonged postexposure prophylaxis usually required.14 37 38 A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure.38 CDC, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend that postexposure prophylaxis in unvaccinated individuals be continued for >60 days following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures).14 15 37 45 The USPHS Advisory Committee on Immunization Practices (ACIP) and USAMRIID recommend that individuals who are partially or fully vaccinated against anthrax receive postexposure prophylaxis for ≥30 days; if given in conjunction with anthrax vaccine, continue prophylaxis for at least 7–14 days after the third vaccine dose.37 46

Treatment of Inhalational Anthrax
Oral or IV

400 mg once daily14 for ≥60 days.14 16 37

Initial parenteral regimen preferred; use oral regimen for initial treatment only when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).14 16 37 Continue for total duration of >60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.14 16 37

Mycobacterial Infections
Active Tuberculosis
Oral or IV

400 mg once daily.40 Must be used in conjunction with other antituberculosis agents.40

Multiple-drug regimen usually given for 12–18 months when rifampin-resistant M. tuberculosis are involved; for 18–24 months when isoniazid- and rifampin-resistant strains are involved; or for 24 months when the strain is resistant to isoniazid, rifampin, ethambutol, and/or pyrazinamide.40

Disseminated MAC Infections
Oral

HIV-infected: 400 mg once daily.412

Prescribing Limits

Adults

Do not exceed usual dosage or duration of therapy.1

Special Populations

Hepatic Impairment

Dosage adjustments not necessary in adults with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).1 Use with caution in patients with hepatic impairment.1 (See Hepatic Impairment under Cautions.)

Renal Impairment

Dosage adjustments not necessary in adults with renal impairment, including those on hemodialysis or CAPD.1

Geriatric Patients

Routine dosage adjustment based solely on age not necessary.1 Select dosage with caution because of possible age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Cautions for Avelox

Contraindications

  • Known hypersensitivity to moxifloxacin, other quinolones, or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Tendinopathy and Tendon Rupture

Systemic fluoroquinolones, including moxifloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups.1 128 129 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 128 129 (See Geriatric Use under Cautions.)

Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.1 128 129 Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.1

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair.1 Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.1

Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.1

Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs.1 128 129 Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint).1 128 129 (See Advice to Patients.)

Myasthenia Gravis Patients

May exacerbate muscle weakness in myasthenia gravis patients;1 death or need for ventilatory support reported.1

Avoid use in patients with known history of myasthenia gravis.1

Prolongation of QT Interval

Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including moxifloxacin.1 55

Do not exceed usual recommended dosage or IV infusion rate since this may increase risk of prolonged QT interval.1

Avoid use in patients with a history of prolonged QT interval, in those with uncorrected electrolyte disorders (e.g., hypokalemia), and in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.1 (See Drugs that Prolong QT Interval under Interactions.)

Use with caution in patients receiving drugs that prolong QT interval (e.g., cisapride [available in the US only under a limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants) and in those with ongoing proarrhythmic conditions, such as clinically important bradycardia or AMI.1

Risk of QT interval prolongation may be increased in geriatric patients.1 (See Geriatric Use under Cautions.)

Use with caution in patients with mild, moderate, or severe liver cirrhosis.1 (See Hepatic Impairment under Cautions.)

Musculoskeletal Effects

Fluoroquinolones, including moxifloxacin, cause arthropathy and osteochondrosis in immature animals of various species.1 88 89 90 91 92 93 94 95 97 Permanent lesions in cartilage reported in moxifloxacin studies in immature dogs.1 Relevance of these adverse effects in immature animals to use in humans unknown.1 93 94 95 Safety and efficacy not established in children and adolescents <18 years of age (see Pediatric Use under Cautions) or in pregnant or lactating women (see Pregnancy and see Lactation under Cautions).1

CNS Effects

Seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts reported in patients receiving quinolones; may occur after first dose.1

Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures or lower seizure threshold.1

If CNS effects occur, discontinue moxifloxacin and institute appropriate measures.1

Peripheral Neuropathy

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones, including moxifloxacin.1 Symptoms may occur soon after initiation of the drug and may be irreversible.1

Immediately discontinue moxifloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) occur or if there are alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation).1

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 Institute appropriate therapy if superinfection occurs.1

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 96 98 99 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.1 76 80 81 96 98 99 C. difficile produces toxins A and B which contribute to development of CDAD;1 96 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1

Outbreaks of severe CDAD caused by fluoroquinolone-resistant C. difficile have been reported with increasing frequency over the past several years.75 76 77 78 80

Consider CDAD if diarrhea develops and manage accordingly.1 96 98 99 Careful medical history necessary since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.1 96 98 99

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.1 96 98 99 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), appropriate anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 96 98 99

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones, including moxifloxacin.1 Although generally reported after multiple doses, these reactions may occur with first dose.1

Some reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, edema (pharyngeal or facial), dyspnea, urticaria, or pruritus.1

In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported, most frequently after multiple doses.1 These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.1

Discontinue moxifloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.1 23 Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions reported with fluoroquinolones, including moxifloxacin.1

Phototoxicity may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) on areas exposed to sun or artificial ultraviolet (UV) light (usually the face, neck, extensor surfaces of forearms, dorsa of hands).1

Relative potential of the various fluoroquinolones to cause photosensitivity/phototoxicity unclear.1 Factors that contribute to susceptibility to this adverse effect during fluoroquinolone therapy include patient’s skin pigmentation, frequency and duration of exposure to sun and UV light, use of protective clothing and sunscreen, concomitant use of other drugs, and dosage and duration of fluoroquinolone therapy.1

Avoid unnecessary or excessive exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment) while receiving moxifloxacin.1 If patient needs to be outdoors, they should wear loose-fitting clothing that protects skin from sun exposure and use other sun protection measures (sunscreen).1

Discontinue moxifloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.1

General Precautions

Selection and Use of Anti-infectives

When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient.128 129 Most patients tolerate the drugs, but serious adverse reactions (e.g., CNS effects, QT prolongation, C. difficile-associated diarrhea and colitis, damage to liver, kidneys, or bone marrow, alterations in glucose homeostasis) may occur rarely.128 129

To reduce development of drug-resistant bacteria and maintain effectiveness of moxifloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk in rats; may be distributed into human milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in children or adolescents <18 years of age.1 Like other quinolones, moxifloxacin causes arthropathy in juvenile animals.1 (See Musculoskeletal Effects under Cautions.)

AAP states use of fluoroquinolones may be justified in children <18 years of age in special circumstances after careful assessment of the risks and benefits for the individual patient and after these benefits and risks have been explained to the parents or caregivers.292

Geriatric Use

No overall differences in safety or efficacy relative to younger adults.1

Risk of severe tendon disorders, including tendon rupture, is increased in older adults (usually those >60 years of age).1 128 129 This risk is further increased in those receiving concomitant corticosteroids.1 128 129 (See Tendinopathy and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.1

Risk of QT interval prolongation may be increased in geriatric patients.1 (See Prolongation of QT Interval under Cautions.)

Hepatic Impairment

Dosage adjustments not necessary in adults with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).1

Use with caution in patients with any degree of hepatic impairment and in those with mild, moderate, or severe liver cirrhosis.1 Metabolic disturbances associated with hepatic insufficiency may lead to QT interval prolongation.1

Renal Impairment

Dosage adjustments not necessary in adults with renal impairment.1

Common Adverse Effects

GI effects (nausea, diarrhea), headache, dizziness.1

Interactions for Avelox

Not metabolized by CYP isoenzymes and does not inhibit CYP3A4, 2D6, 2C9, 2C19, or 1A2.1 Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.1

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).1 Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.1 Use with caution in patients receiving drugs that prolong QT interval (e.g., cisapride [commercially available under a limited-access protocol only], erythromycin, antipsychotic agents, tricyclic antidepressants).1 (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug

Interaction

Comments

Antacids (aluminum- or magnesium-containing)

Decreased absorption of oral moxifloxacin1

Administer oral moxifloxacin at least 4 hours before or 8 hours after such antacids1

Anticoagulants, oral (warfarin)

No clinically important pharmacokinetic interactions;1 may enhance anticoagulant effects of warfarin1

Monitor PT, INR, or other suitable coagulation tests1

Antifungal agents, azoles

Itraconazole: No effect on pharmacokinetics of either drug1

Atenolol

No effect on atenolol pharmacokinetics1

Calcium supplements

No effect on moxifloxacin pharmacokinetics1

Corticosteroids

Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age1 128 129

Didanosine

Decreased absorption of oral moxifloxacin with buffered didanosine preparations1

Administer oral moxifloxacin at least 4 hours before or 8 hours after buffered didanosine (pediatric oral solution admixed with antacid)1

Digoxin

Transient increase in digoxin concentrations; no clinically important effect on pharmacokinetics of either drug1

Dosage adjustment of moxifloxacin or digoxin not necessary1

Glyburide

No clinically important effect on glyburide pharmacokinetics1

Hormonal contraceptives

No clinically important effect on pharmacokinetics of ethinyl estradiol/levonorgestrel oral contraceptives1

Iron preparations

Decreased oral absorption of moxifloxacin1 82

Administer oral moxifloxacin at least 4 hours before or 8 hours after iron preparations1

Morphine

No clinically important effect on moxifloxacin pharmacokinetics1

Multivitamins and dietary supplements

Decreased oral absorption of moxifloxacin1

Administer oral moxifloxacin at least 4 hours before or 8 hours after multivitamins or dietary supplements containing iron or zinc1

NSAIAs

Possible increased risk of CNS stimulation, seizures;1 animal studies using other fluoroquinolones suggest risk varies depending on the specific NSAIA86

Probenecid

No clinically important effect on moxifloxacin pharmacokinetics1

Ranitidine

No clinically important effect on moxifloxacin pharmacokinetics1

Sucralfate

Decreased oral absorption of moxifloxacin1

Administer oral moxifloxacin at least 4 hours before or 8 hours after sucralfate1

Theophylline

No clinically important effect on pharmacokinetics of either drug1

Avelox Pharmacokinetics

Absorption

Bioavailability

86–92%.1 4 5

Peak plasma concentrations attained within 0.5–4 hours; steady-state attained after at least 3 days.1 6

Food

Administration of a 400-mg tablet with a high-fat breakfast (2 eggs fried in butter, 2 strips bacon, 2 slices buttered toast, hash brown potatoes, 240 mL whole milk) decreased peak plasma concentrations and AUC by 12 and 3%, respectively; not considered clinically important.1 83

Administration of a 400-mg tablet with yogurt (approximately 300 mg calcium) decreases peak plasma concentration and AUC by 16 and 6%, respectively; not considered clinically important.1 84

Distribution

Extent

Widely distributed into body tissues and fluids, including saliva, nasal and bronchial secretions, sinus mucosa, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids.1

Distributed into CSF in rabbits.48

Distributed into milk in rats; may be distributed into human milk.1

Plasma Protein Binding

30–50%.1 6

Elimination

Metabolism

Approximately 52% of an oral or IV dose is metabolized via glucuronide and sulfate conjugation; the metabolites are not microbiologically active.1 4

Not metabolized by CYP isoenzymes.1 4

Elimination Route

Eliminated in urine and by biliary excretion and metabolism.33

Approximately 45% of an oral or IV dose excreted unchanged (20% in urine and 25% in feces).1 A total of 96% of an oral dose is excreted as unchanged drug or metabolites.1 4

Half-life

Adults with normal renal and hepatic function: Mean of 11.5–15.6 hours following single or multiple oral doses.1 6 33 34

Adults with normal renal and hepatic function: Mean of 8.2–15.4 hours following single or multiple IV doses.1

Special Populations

Pharmacokinetics in geriatric patients similar to younger adults.1

Concentrations of sulfate and glucuronide conjugates are increased in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); clinical importance not determined.1 Plasma concentrations of moxifloxacin and its metabolites in patients with severe hepatic impairment (Child-Pugh class C) are similar to those reported in patients with mild or moderate hepatic impairment.1

Pharmacokinetics not substantially affected by mild, moderate, or severe renal impairment.1 In patients with Clcr <20 mL/minute undergoing hemodialysis or CAPD, moxifloxacin concentrations are not affected but concentrations of the sulfate and glucuronide conjugates are increased; clinical importance of this has not be determined.1

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).1 Avoid high humidity.1

Parenteral

Injection

25°C (may be exposed to 15–30°C).1 Do not refrigerate.1

For single-use only, discard any unused portions.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1 HID

Compatible

Dextrose 5 or 10% in water

Ringer’s injection, lactated

Sodium chloride 0.9%

Sodium chloride 1 M injection

Drug Compatibility
Y-Site CompatibilityHID

Compatible

Ceftaroline fosamil

Doripenem

Hydroxyethyl starch 130/0.4 in sodium chloride 0.9%

Vasopressin

Actions and Spectrum

  • Usually bactericidal.1

  • Like other fluoroquinolones, moxifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1

  • Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative aerobic bacteria, some anaerobic bacteria, and some other organisms (e.g., Chlamydia, Mycoplasma, Mycobacterium).1 23 24 28

  • More active in vitro than some other fluoroquinolones (e.g., ciprofloxacin, levofloxacin, ofloxacin) against S. pneumoniae7 8 9 while generally retaining the in vitro activity of these drugs against gram-negative bacteria and etiologic agents of atypical pneumonia (e.g., C. pneumoniae, M. pneumoniae, Legionella).3 7 8

  • Gram-positive aerobes: Active in vitro and in clinical infections against Enterococcus faecalis, Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only),1 24 S. pneumoniae (including multidrug-resistant strains),1 56 S. anginosus,1 S. constellatus,1 24 27 and S. pyogenes (group A β-hemolytic streptococci).1 24 Also active in vitro against S. epidermidis (oxacillin-susceptible strains only),1 24 S. agalactiae (group B streptococci),1 24 and viridans streptococci.1

  • Gram-negative aerobes: Active in vitro and in clinical infections against Enterobacter cloacae,1 Escherichia coli,1 24 H. influenzae,1 24 H. parainfluenzae,1 K. pneumoniae,1 M. catarrhalis,1 and Proteus mirabilis.1 Also active in vitro against Citrobacter freundii,1 24 K. oxytoca,1 and Legionella pneumophila.1

  • Anaerobes and other organisms: Active in vitro and in clinical infections against Bacteroides fragilis, B. thetaiotaomicron, Clostridium perfringens, C. pneumoniae, Peptostreptococcus,1 24 41 and M. pneumoniae.1 Also active in vitro against M. tuberculosis,23 24 28 M. avium complex (MAC), 23 M. kansasii,23 M. fortuitum,23 26 Fusobacterium,1 and Prevotella.1 24

  • Active against some strains of M. tuberculosis resistant to isoniazid, rifampin, or streptomycin,24 28 but moxifloxacin-resistant M. tuberculosis have been reported and some multidrug-resistant strains (i.e., strains resistant to rifampin and isoniazid) also are resistant to moxifloxacin or other fluoroquinolones.64 66 67 68 69 71 72

  • Some cross-resistance occurs between moxifloxacin and other fluoroquinolones.1

Advice to Patients

  • Advise patients that antibacterials (including moxifloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1

  • Importance of completing full course of therapy, even if feeling better after a few days.1

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with moxifloxacin or other antibacterials in the future.1

  • May be taken without regard to meals,1 but should be taken with liberal amounts of fluids.1

  • Importance of taking moxifloxacin at least 4 hours before or 8 hours after multivitamins or dietary supplements containing iron or zinc; aluminum- or magnesium-containing antacids; or buffered didanosine (pediatric oral solution admixed with antacid).1

  • Increased risk of tendinitis and tendon rupture in all age groups and further increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients.1 128 129 Importance of resting and refraining from exercise at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon, weakness or inability to use a joint) and discontinuing the drug and contacting a clinician regarding changing to an anti-infective that is not a fluoroquinolone.1 128 129 (See Tendinopathy and Tendon Rupture under Cautions.)

  • Advise patients that moxifloxacin may worsen myasthenia gravis symptoms; importance of immediately contacting clinician if any worsening muscle weakness or breathing problems occur.1

  • Potential for moxifloxacin to cause dizziness and lightheadedness; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.1

  • May be associated with hypersensitivity reactions (including anaphylactic reactions), even after a single dose.1 Importance of immediately discontinuing moxifloxacin and informing clinician at first sign of rash, jaundice, or any other sign of hypersensitivity.1

  • Risk of photosensitivity/phototoxicity reactions following exposure to sun or UV light while receiving fluoroquinolones.1 Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., tanning beds, UVA/UVB treatment) and using protective measures (e.g., wearing loose-fitting clothes, sunscreen) if outdoors during moxifloxacin therapy.1 Discontinue moxifloxacin and inform a clinician if a sunburn-like reaction or skin eruption occurs.1

  • Advise patients that peripheral neuropathies have been reported with moxifloxacin and that symptoms may occur soon after initiation of the drug and may be irreversible.1 Importance of immediately discontinuing the drug and contacting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) occur.1

  • Advise patient that moxifloxacin may prolong QT interval and should be avoided in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents and used with caution in those receiving drugs that prolong QT interval (e.g., cisapride [available in the US only under a limited access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants).1

  • Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., recent hypokalemia, bradycardia, AMI).1

  • Importance of informing clinician if medical history includes palpitations, seizures, or fainting spells or if any of these occur during therapy.1

  • Advise patients that seizures have been reported and importance of informing clinician about any history of seizures before taking moxifloxacin.1

  • Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially drugs that may affect QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Moxifloxacin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

400 mg of (of moxifloxacin)

Avelox

Bayer (also distributed by Schering-Plough)

Parenteral

Injection, for IV infusion

400 mg (of moxifloxacin) in 0.8% sodium chloride

Avelox I.V. (in flexible containers)

Bayer (also distributed by Schering-Plough)

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Avelox 400MG Tablets (SCHERING): 30/$562.01 or 90/$1,581.89

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 25, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bayer. Avelox (moxifloxacin hydrochloride) tablets and Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection) prescribing information. Wayne, NJ; 2013 Aug.

2. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002. 62:13-59.

3. Blondeau JM. Expanded activity and utility of the new fluoroquinolones: a review. Clin Ther. 1999; 21:3-40. [IDIS 424194] [PubMed 10090423]

4. Stass H, Kubitza D. Pharmacokinetics and elimination of moxifloxacin after oral and intravenous administration in man. J Antimicrob Chemother. 1999; 43(Suppl):83B-90B.

5. Ballow C, Lettieri J, Agarwal V et al. Absolute bioavailability of moxifloxacin. Clin Ther. 1999; 21:513-22. [IDIS 427449] [PubMed 10321420]

6. Stass H, Dalhoff A, Kubitza D et al. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrob Agents Chemother. 1998; 42:2060-5. [IDIS 411422] [PubMed 9687407]

7. Blondeau JM. A review of the comparative in-vitro activities of 12 antimicrobial agents, with a focus on five new ‘respiratory quinolones’. J Antimicrob Chemother. 1999; 43(Suppl):1B-11B.

8. Reinert RR, Schlaeger JJ, Lëtticken R. Moxifloxacin: a comparison with other antimicrobial agents of in-vitro activity against Streptococcus pneumoniae. 1998; 42:803-6.

9. Buxbaum A, Straschil U, Moser C et al. Comparative susceptibility to penicillin and quinolones of 1385 Streptococcus pneumoniae isolates. J Antimicrob Chemother. 1999; 43(Suppl):13B-18B.

10. Man I, Murphy J, Ferguson J. Fluoroquinlone phototoxicity: a comparison of moxifloxacin and lomefloxacin in normal volunteers. J Antimicrob Chemother. 1999; 43(Suppl):B77-B82. [IDIS 428610] [PubMed 10382879]

11. Bayer Corporation, West Haven, CT: Personal communication.

12. US Food and Drug Administration. Janssen Pharmaceutica stops marketing cisapride in the U.S. FDA Talk Paper. Rockville, MD; 2000 March 23.

13. Parish LC, Routh HB, Miskin B et al. Moxifloxacin versus cephalexin in the treatment of uncomplicated skin infections. Int J Clin Pract. 2000; 54:497-503. [IDIS 456574] [PubMed 11198726]

14. Inglesby TV, O’Toole T, Henderson DA et al for the Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA. 2002; 287:2236-52. [IDIS 480001] [PubMed 11980524]

15. Centers for Disease Control and Prevention. Update: investigation of anthrax associated with intentional exposure and interim public health guidelines, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:889-93. [IDIS 471389] [PubMed 11686472]

16. Centers for Disease Control and Prevention. Update: investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:909-19. [IDIS 471910] [PubMed 11699843]

20. Bishai W. Current issues on resistance, treatment guidelines, and the appropriate use of fluoroquinolones for respiratory tract infections. Clin Ther. 2002; 24:838-50. [IDIS 483635] [PubMed 12117077]

21. Bearden DT, Danziger LH. Mechanism of action of and resistance to quinolones. Pharmacotherapy. 2001; 21:224S-32S. [IDIS 472236] [PubMed 11642689]

23. Gillespie SH, Billington O. Activity of moxifloxacin against mycobacteria. J Antimicrob Chemother. 1999; 44:393-5. [IDIS 434684] [PubMed 10511409]

24. Woodcock JM, Andrews JM, Boswell FJ et al. In vitro activity of BAY 12-8039, a new fluoroquinolone. Antimicrob Agents Chemother. 1997; 41:101-6. [PubMed 8980763]

25. Valerio G, Bracciale P, Manisco V. Long-term tolerance and effectiveness of moxifloxacin therapy for tuberculosis: preliminary results. J Chemother. 2003; 15:77-70.

26. Yang SC, Hsueh PR, Lai HC et al. High prevalence of antimicrobial resistance in rapidly growing mycobacteria in Taiwan. Antimicrob Agents Chemother. 2003; 47:1958-62. [PubMed 12760874]

27. Zhanel GG, Palatnick L, Nichol KA et al. Antimicrobial resistance in respiratory tract Streptococcus pneumoniae isolates: results of the Canadian respiratory organism susceptibility study, 1997 to 2002. Antimicrob Agents Chemother. 2003; 47:1867-74. [PubMed 12760860]

28. Alvirez-Freites EJ, Carter JL, Cynamon MH. In vitro and in vivo activities of gatifloxacin against Mycobacterium tuberculosis. Antimicrob Agents Chemother. 2002; 46:1022-5. [PubMed 11897584]

31. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007; 44 Suppl 2:S27-72. [PubMed 17278083]

32. Malangoni MA, Song J, Herrington J et al. Randomized controlled trial of moxifloxacin compared with piperacillin–tazobactam and amoxicillin–clavulanate for the treatment of complicated intra-abdominal infections. Ann Surg. 2006; 244:204-11. [PubMed 16858182]

33. Sullivan JT, Woodruff M, Lettieri J et al. Pharmacokinetics of a once-daily oral dose of moxifloxacin (Bay 12-8039), a new enantiomerically pure 8-methoxy quinolone. Antimicrob Agents Chemother. 1999; 43:2793-7. [IDIS 438052] [PubMed 10543767]

34. Nightingale CH. Moxifloxacin, a new antibiotic designed to treat community-acquired respiratory tract infections: a review of microbiologic and pharmacokinetic-pharmacodynamic characteristics. Pharmacotherapy. 2000; 20:245-56. [IDIS 442447] [PubMed 10730681]

35. Baddour LM, Wilson WR, Bayer AS et al. Infective endocarditis: diagnosis, antimicrobial therapy, and management of complications: a statement for healthcare professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease of the Young, and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American Heart Association: endorsed by the Infectious Diseases Society of America. Circulation. 2005; 111:e394-433. [PubMed 15956145]

37. US Army Medical Research Institute of Infectious Disease. USAMRIID’s medical management of biologic casualties handbook. 5th ed. USAMRIID: Fort Detrick, MD; 2004 Aug.

38. Brookmeyer R, Johnson E, Bollinger R. Modeling the optimum duration of antibiotic prophylaxis in an anthrax outbreak. Proc Natl Acad Sci. 2003; 100:10129-32. [PubMed 12890865]

39. Solomkin JS, Mazuski JE, Bradley JS et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010; 50:133-64. [PubMed 20034345]

40. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of American. MMWR Recomm Rep. 2003; 52(RR-11):1-88.

41. Goldstein EJC, Citron DM, Warren YA et al. In vitro activity of moxifloxacin against 923 anaerobes isolated from human intra-abdominal infections. Antimicrob Agents Chemother. 2006; 50:148-55. [PubMed 16377680]

42. Betriu C, Rodriguez AI, Gomez M et al. Changing patterns of fluoroquinolone resistance among Bacteroides fragilis group organisms over a 6-year period (1997-2002). Diagn Microbiol Infect Dis. 2005; 53:221-3. [PubMed 16243476]

43. Stevens DL, Bisno AL, Chambers HF et al. Practice guidelines for the diagnosis and management of skin and soft-tissue infections. Clin Infect Dis. 2005; 41;1373-406. [PubMed 16231249]

44. Giordano P, Song J, Pertel P et al. Sequential intravenous/oral moxifloxacin versus intravenous piperacillin-tazobactam followed by oral amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. Int J Antimicrob Agents. 2005; 26:357-65. [PubMed 16229991]

45. Centers for Disease Control and Prevention. Additional options for preventive treatment for persons exposed to inhalational anthrax. MMWR Morb Mortal Wkly Rep. 2001; 50:1142.

46. Centers for Disease Control and Prevention. Use of anthrax vaccine in response to terrorism: supplemental recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2002; 51:1024-6. [IDIS 489786] [PubMed 12458919]

47. Tunkel AR, Hartman BJ, Kaplan SL et al. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004; 39:1267-84. [IDIS 537717] [PubMed 15494903]

48. Rodriguez-Cerrato V, McCoig CC, Michelow IC et al. Pharmacodynamics and bactericidal activity of moxifloxacin in experimental Escherichia coli meningitis. Antimicrob Agents Chemother. 2001; 45:3092-7.

49. Rodriquez-Cerrato V, McCoig CC, Saavedra J et al. Garenoxacin (BMS-284756) and moxifloxacin in experimental meningitis caused by vancomycin-tolerant pneumococci. Antimicrob Agents Chemother. 2003; 47:211-5.

50. Anon. Drugs for pneumonia. Med Lett Treat Guid. 2003; 1:83-8.

51. American Thoracic Society and the Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005; 171:388-416. [PubMed 15699079]

53. Anzueto A, Niederman MS, Pearle J et al. Community-acquired pneumonia recovery in the elderly (CAPRIE): efficacy and safety of moxifloxacin therapy versus that of levofloxacin therapy. Clin Infect Dis. 2006; 42:73-81. [PubMed 16323095]

54. Welte T, Petermann W, Schurmann D et al. Treatment with sequential intravenous or oral moxifloxacin was associated with faster clinical improvement than was standard therapy for hospitalized patients with community-acquired pneumonia who received initial parenteral therapy. Clin Infect Dis. 2005; 41:1697-705. [PubMed 16288390]

55. Morganroth J, DiMarco JP, Anzueto A et al. A randomized trial comparing the cardiac rhythm safety of moxifloxacin vs levofloxacin in elderly patients hospitalized with community-acquired pneumonia. Chest. 2005; 128:3398-406. [PubMed 16304291]

56. Fogarty C, Torres A, Choudhri S et al. Efficacy of moxifloxacin for treatment of penicillin-, macrolide- and multidrug-resistant Streptococcus pneumoniae in community-acquired pneumonia. Int J Clin Pract. 2005; 59:1253-9. [PubMed 16236076]

57. Niederman MS, Challenges in the management of community-acquired pneumonia: the role of quinolones and moxifloxacin. Clin Infect Dis. 2005; 41:S158-66.

58. Shams WE, Evans ME. Guide to selection of fluoroquinolones in patients with lower respiratory tract infections. Drugs. 2005; 65:949-91. [PubMed 15892589]

59. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:18-26.

60. Burman WJ, Goldberg S, Johnson JL et al. Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis. Am J Respir Crit Care Med. 2006; 174:331-8. [PubMed 16675781]

61. Codecasa LR, Ferrara G, Ferrarese M et al. Long-term moxifloxacin in complicated tuberculosis patients with adverse reactions or resistance to first line drugs. Respir Med. 2006; 100:1566-72. [PubMed 16469488]

64. Gandhi NR, Moll A, Sturm AW et al. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet. 2006; 368:1575-80. [PubMed 17084757]

65. Johnson JL, Hadad DJ, Boom WH et al. Early and extended early bactericidal activity of levofloxacin, gatifloxacin and moxifloxacin in pulmonary tuberculosis. Int J Tuberc Lung Dis. 2006; 10:605-12. [PubMed 16776446]

66. Aubry A, Veziris N, Cambau E et al. Novel gyrase mutations in quinolone-resistant and -hypersusceptible clinical isolates of Mycobacterium tuberculosis: functional analysis of mutant enzymes. Antimicrob Agents Chemother. 2006; 50:104-12. [PubMed 16377674]

67. Kam KM, Yip CW, Cheung TL et al. Stepwise decrease in moxifloxacin susceptibility amongst clinical isolates of multidrug-resistant Mycobacterium tuberculosis: correlation with ofloxacin susceptibility. Microb Drug Resist. 2006; 12:7-11. [PubMed 16584301]

68. Somasundaram S, Paramasivan NC. Susceptibility of Mycobacterium tuberculosis strains to gatifloxacin and moxifloxacin by different methods. Chemotherapy. 2006; 52:190-5. [PubMed 16714850]

69. Shandil RK, Jayaram R, Kaur P et al. Moxifloxacin, ofloxacin, sparfloxacin, and ciprofloxacin against Mycobacterium tuberculosis: evaluation of in vitro and pharmacodynamic indices that best predict in vivo efficacy. Antimicrob Agents Chemother. 2007; 51:576-82. [PubMed 17145798]

71. Granich RM, Oh P, Lewis B et al. Multidrug resistance among persons with tuberculosis in California, 1994-2003. JAMA. 2005; 293:2732-9. [PubMed 15941802]

72. World Health Organization. Extensively drug-resistant tuberculosis (XDR-TB): recommendations for prevention and control. Wkly Epidemiol Rec. 2006; 45:430-2.

75. McDonald LC, Killgore GE, Thompson A et al. An epidemic, toxin gene-variant strain of Clostridium difficile. N Engl J Med. 2005; 353:2433-41. [PubMed 16322603]

76. Loo VG, Poirier L, Miller MA et al. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N Engl J Med. 2005; 353:2442-9. [PubMed 16322602]

77. McDonald LC, Owings M, Jernigan DB. Clostridium difficile infection in patients discharged from US short-stay hospitals, 1996-2003. Emerg Infect Dis. 2006; 12:409-15. [PubMed 16704777]

78. Bartlett JG, Peri TM. The new Clostridium difficile–what does it mean? N Engl J Med. 2005; 353:2503-5.

79. Centers for Disease Control and Prevention. Severe Clostridium difficile-associated disease in populations previously at low risk–four states, 2005. MMWR Morb Mortal Wkly Rep. 2005; 54:1201-5. [PubMed 16319813]

80. Kazakova SV, Ware K, Baughman B et al. A hospital outbreak of diarrhea due to an emerging epidemic strains of Clostridium difficile. Arch Intern Med. 2006; 166:2518-24. [PubMed 17159019]

81. Dhalla IA, Mamdani MM, Simor AE et al. Are broad-spectrum fluoroquinolones more likely to cause Clostridium difficile-associated disease? Antimicrob Agents Chemother. 2006; 50:3216-9.

82. Stass H, Kubitza D. Effects of iron supplements on the oral bioavailability of moxifloxacin, a novel 8-methoxyfluroquinolone, in humans. Clin Pharmacokinet. 2001; 40 (suppl 1):57-62. [PubMed 11352443]

83. Lettieri J, Vargas R, Agarwal V et al. Effect of food on the pharmacokinetics of a single oral dose of moxifloxacin 400 mg in healthy male volunteers. Clin Pharmacokinet. 2001; 40 (suppl 1):19-25 [PubMed 11352438]

84. Stass H, Kubitza D. Effects of dairy products on the oral bioavailability of moxifloxacin, a novel 8-methoxyfuloroquinolone, in healthy volunteers. Clin Pharmacokinet. 2001; 40 (suppl 1):33-8. [PubMed 11352440]

85. Ziganshina LE, Vizel AA, Squire SB. Fluoroquinolones for treating tuberculosis. Cochrane Database Syst Rev. 2005; Jul 20:CD004795.

86. Hori S, Kizu J, Kawamura M. Effects of anti-inflammatory drugs on convulsant activity of quinolones: a comparative study of drug interactions between quinolones and anti-inflammatory drugs. J Infect Chemother. 2003; 9:314-20. [PubMed 14691652]

87. Ball P. Long-term use of quinolones and their safety. Rev Infect Dis. 1989; 11(Suppl 5):S1365-9. [IDIS 307993] [PubMed 2672258]

88. Davis GJ, McKenzie ME. Toxicologic evaluation of ofloxacin. Am J Med. 1989; 87(Suppl 6C):43S-46S. [PubMed 2690619]

89. Mayer DG. Overview of toxicological studies. Drugs. 1987; 34(Suppl 1):150-3. [PubMed 3325258]

90. Kato M, Onodera T. Morphological investigation of cavity formation in articular cartilage induced by ofloxacin in rats. Fund Appl Toxicol. 1988; 11:110-9.

91. Hooper DC, Wolfson JS. Fluoroquinolone antimicrobial agents. N Engl J Med. 1991; 324:384-94. [IDIS 277079] [PubMed 1987461]

92. Paton JH, Reeves DS. Fluoroquinolone antibiotics: microbiology, pharmacokinetics and clinical uses. Drugs. 1988; 36:193-228. [IDIS 245416] [PubMed 3053126]

93. Maggiolo F, Caprioli S, Suter F. Risk/benefit analysis of quinolone use in children: the effect on diarthrodial joints. J Antimicrob Chemother. 1990; 26:469-71. [PubMed 2254219]

94. Pfister K, Mazur D, Vormann J et al. Diminished ciprofloxacin-induced chondrotoxicity by supplementation with magnesium and vitamin E in immature rats. Antimicrob Agents Chemother. 2007; 51:1022-7. [PubMed 17210779]

95. Stahlmann R. Safety profile of the quinolones. J Antimicrob Chemother. 1990; 26(Suppl D):31-44. [PubMed 2286589]

96. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55. [PubMed 20307191]

97. Christ W, Lehnert T, Ulbrich B. Specific toxicologic aspects of the quinolones. Rev Infect Dis. 1988; 10(Suppl 1):S141-6. [IDIS 311600] [PubMed 3279489]

98. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile-associated diarrhea and colitis. Am J Gastroenterol. 1997; 92:739-50. [IDIS 386628] [PubMed 9149180]

99. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile-associated disease. Am J Health-Syst Pharm. 1998; 55:1407-11. [IDIS 407213] [PubMed 9659970]

128. Food and Drug Administration. FDA news. FDA requests boxed warnings on fluoroquinolone antimicrobial drugs. From FDA website. Accessed 2008 Sept 8.

129. Food and Drug Administration. Information for healthcare professionals. FDA alert regarding fluoroquinolone antimicrobial drugs. 2008 Jul 8. From FDA website. Accessed 2008 Sept 8.

192. Chow AW, Benninger MS, Brook I et al. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012; 54:e72-e112. [PubMed 22438350]

193. Wald ER, Applegate KE, Bordley C et al. Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years. Pediatrics. 2013: 132:e262-80.; :. [PubMed 23796742]

292. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

412. Panel on Opportunistic Infections in HIV-infected Adults and Adolescents. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America (May 7, 2013). Updates may be available at HHS AIDS Information (AIDSinfo) website.

477. Guerrant RL, Gilder TV, Steiner TS et al. Practice guidelines for the management of infectious diarrhea. Clin Infect Dis. 2001; 32:331-50. [IDIS 466024] [PubMed 11170940]

671. Griffith DE, Aksamit T, Brown-Elliott BA et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416. [PubMed 17277290]

681. Centers for Disease Control and Prevention. Diagnosis and management of foodborne illnesses: a primer for physicians. MMWR Recomm Rep. 2001; 50(RR-2):1-69.

HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013: 829-30.

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