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Avelox

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)

    Serious Adverse Reactions
  • Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that have occurred together.1 Discontinue immediately and avoid use of fluoroquinolones, including moxifloxacin, in patients who have experienced any of these serious adverse reactions.1 (See Warnings 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

  • Because of risk of serious adverse reactions, use moxifloxacin for treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.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

Use for treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.1 140 145 Because systemic fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient (see Cautions)1 140 145 and because acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients,1 risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.140 145

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

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

Consult current IDSA clinical practice guidelines available at for additional information on management of respiratory tract infections.31 51

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

Consult current IDSA clinical practice guidelines available at for additional information on management of skin and skin structure infections.26 43

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 available at for additional information on management of intra-abdominal infections.39

Endocarditis

Alternative for treatment of endocarditis (native or prosthetic valve or other prosthetic material) caused by fastidious gram-negative bacilli known as the HACEK group (Haemophilus, Aggregatibacter, Cardiobacterium hominis, Eikenella corrodens, Kingella).127

AHA and IDSA recommend ceftriaxone (or other third or fourth generation cephalosporin),127 but state that a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered in patients who cannot tolerate cephalosporins.127 Consultation with an infectious disease specialist recommended.127

GI Infections

Alternative for treatment of Salmonella gastroenteritis (with or without bacteremia) in HIV-infected adults.440 CDC, NIH, and IDSA recommend ciprofloxacin as drug of choice; other fluoroquinolones (levofloxacin, moxifloxacin) also may be effective.440 Depending on in vitro susceptibility, other alternatives are co-trimoxazole and third generation cephalosporins (ceftriaxone, cefotaxime).440 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.440

Treatment of shigellosis caused by susceptible Shigella when anti-infectives indicated.440 477 Anti-infectives generally indicated in addition to fluid and electrolyte replacement for treatment of patients with severe shigellosis, dysentery, or underlying immunosuppression.292 440 Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common.292 A fluoroquinolone (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) generally recommended, but consider that fluoroquinolone-resistant Shigella reported in the US.440 Depending on in vitro susceptibility, alternatives include co-trimoxazole or azithromycin (not recommended in those with bacteremia);440 ceftriaxone or azithromycin has been recommended when susceptibility of the isolate is unknown or ampicillin- or co-trimoxazole-resistant strains are involved.292 440 477

Anthrax

Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).663 668 CDC, US Public Health Service Advisory Committee on Immunization Practices (ACIP), US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend oral ciprofloxacin and oral doxycycline as initial drugs of choice for prophylaxis following such exposures, including exposures that occur in the context of biologic warfare or bioterrorism.663 668 683 686 Some of these experts state that levofloxacin or other oral fluoroquinolones (moxifloxacin, ofloxacin) are alternatives when ciprofloxacin or doxycycline cannot be used.663 668

Alternative for treatment of inhalational anthrax when a parenteral regimen not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).668 683 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) 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.668 683 686

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).63

Safety and efficacy not established for CNS infections.63 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.63

Tuberculosis

Alternative (second-line) agent for use in multiple-drug regimens for treatment of active tuberculosis caused by Mycobacterium tuberculosis.218 231 276 440

Although potential role of fluoroquinolones and optimal length of therapy not fully defined, ATS, CDC, IDSA, and others state that use of fluoroquinolones as alternative (second-line) agents can be considered for treatment of active tuberculosis in patients intolerant to certain first-line agents and in those with relapse, treatment failure, or M. tuberculosis resistant to certain first-line agents.218 231 276 440 If a fluoroquinolone used in multiple-drug regimens for treatment of active tuberculosis, ATS, CDC, IDSA, and others recommend levofloxacin or moxifloxacin.218 231 276 440

Consider that fluoroquinolone-resistant M. tuberculosis reported and there are increasing 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

Consult most recent ATS, CDC, and IDSA recommendations for treatment of tuberculosis and other mycobacterial infections for more specific information.218 440

Other Mycobacterial Infections

Has been used in multiple-drug regimens for treatment of disseminated infections caused by Mycobacterium avium complex (MAC).440 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,440 671 although 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

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

Consult most recent ATS, CDC, and IDSA recommendations for treatment of other mycobacterial infections for more specific information.440 671

Nongonococcal Urethritis

Alternative for treatment of nongonococcal urethritis (NGU).344 CDC recommends azithromycin or doxycycline;344 alternatives are erythromycin, levofloxacin, or ofloxacin.344 For persistent or recurrent NGU in men compliant with previous treatment who have not been reexposed to an untreated sexual partner(s), CDC recommends that those initially treated with azithromycin be retreated with moxifloxacin.344

Plague

Treatment of plague, including pneumonic and septicemic plague, caused by Yersinia pestis.1 Streptomycin (or gentamicin) historically has been considered regimen of choice for treatment of plague;292 538 683 688 alternatives are doxycycline (or tetracycline), chloramphenicol (a drug of choice for plague meningitis), fluoroquinolones (ciprofloxacin [a drug of choice for plague meningitis], levofloxacin, moxifloxacin), or co-trimoxazole (may be less effective than other alternatives).292 538 683 688 Regimens recommended for treatment of naturally occurring or endemic bubonic, septicemic, or pneumonic plague also recommended for plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.683 688

Postexposure prophylaxis following high-risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism).1 683 688 Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin); co-trimoxazole and chloramphenicol are alternatives.683 688

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 who do not tolerate or are unable to take the drug orally and in other patients when IV route offers a clinical advantage.1 If IV route used initially, switch to oral route when clinically indicated.1

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

Oral Administration

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

Administer orally at least 4 hours before or 8 hours after antacids containing magnesium or aluminum, metal cations (e.g., iron), sucralfate, multivitamins or dietary supplements containing iron or zinc, or buffered didanosine (pediatric oral solution admixed with antacid).1 (See Interactions.)

IV Infusion

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

Do not admix with other drugs or infuse simultaneously through same tubing with other drugs.1 If same IV line or a Y-type line used for sequential infusion of other drugs or if piggyback method of administration used, flush tubing before and after infusion of moxifloxacin using IV solution compatible with both moxifloxacin and the other drug(s).1

Inspect visually for particulate matter prior to administration;1 the premixed solution should appear yellow.1

Does not contain preservatives; discard any unused portions.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;1 dosage expressed in terms of moxifloxacin.1

Dosage of oral and IV moxifloxacin is identical.1 Dosage adjustments not needed when switching from IV to oral administration.1

Adults

Respiratory Tract Infections
Acute Bacterial Sinusitis
Oral or IV

400 mg once daily for 10 days.1 (See Respiratory Tract Infections under Uses.)

Acute Bacterial Exacerbations of Chronic Bronchitis
Oral or IV

400 mg once daily for 5 days.1 (See Respiratory Tract Infections under Uses.)

Community-acquired Pneumonia (CAP)
Oral or IV

400 mg once daily for 7–14 days.1

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;39 longer duration not associated with improved outcome and not recommended unless adequate source control is difficult to achieve.39

GI Infections
Salmonella Gastroenteritis
Oral or IV

HIV-infected: 400 mg once daily.440

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/mm3.440

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.440 Consider secondary prophylaxis in those with CD4+ T-cells <200 cells/mm3 and severe diarrhea.440

Shigella Infections
Oral or IV

HIV-infected: 400 mg once daily.440

Recommended duration is 7–10 days for gastroenteritis or ≥14 days for bacteremic infections.440 Up to 6 weeks may be required for recurrent infections, especially if CD4+ T-cells <200 cells/mm3.440

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

400 mg once daily.668

Initiate prophylaxis as soon as possible following suspected or confirmed exposure to aerosolized B. anthracis.663 668 683

Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores unclear.668 683 767 Because of the possible persistence of spores in lung tissue following an aerosol exposure, CDC, ACIP, US Working Group on Civilian Biodefense, and USAMRIID recommend that anti-infective postexposure prophylaxis in unvaccinated individuals be continued for ≥60 days following a confirmed exposure.599 663 668 682 683

If used in conjunction with anthrax vaccine, ACIP and USAMRIID recommend continuing anti-infective prophylaxis until 14 days after the third vaccine dose (even if this results in >60 days of anti-infective prophylaxis).663 683

Fully or partially vaccinated laboratory workers or other individuals working in occupations that result in repeated exposure to aerosolized B. anthracis spores: ACIP recommends anti-infective prophylaxis for ≥30 days in conjunction with any remaining indicated vaccine doses if there is any type of disruption of personal protective equipment.663

Unvaccinated workers following an occupational exposure to B. anthracis spores: ACIP recommends anti-infective prophylaxis for 60 days in conjunction with postexposure vaccination;663 continue anti-infective prophylaxis until 14 days after third vaccine dose (even if this results in >60 days of anti-infective prophylaxis).663

Treatment of Inhalational Anthrax
Oral or IV

400 mg once daily668 for ≥60 days.668 683 686

Initial parenteral regimen preferred; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).668 683 686 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.668 683 686

Mycobacterial Infections
Active Tuberculosis
Oral or IV

400 mg once daily.218 Must be used in conjunction with other antituberculosis agents.218

ATS, CDC, and IDSA state data insufficient to date to support intermittent moxifloxacin regimens for treatment of tuberculosis.218

Disseminated MAC Infections
Oral

HIV-infected: 400 mg once daily.440

Nongonococcal Urethritis
Oral

400 mg once daily for 7 days recommended by CDC for persistent or recurrent NGU in those initially treated with azithromycin.344 (See Uses: Nongonococcal Urethritis.)

Plague
Treatment or Prophylaxis of Plague
Oral or IV

400 mg once daily for 10–14 days.1

Initiate as soon as possible after suspected or known exposure to Y. pestis.1

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

Dosage adjustment based solely on age not necessary.1

Cautions for Avelox

Contraindications

  • History of hypersensitivity to moxifloxacin or other quinolones.1

Warnings/Precautions

Warnings

Disabling and Potentially Irreversible Serious Adverse Reactions

Systemic fluoroquinolones, including moxifloxacin, associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient.1 140 145 May occur within hours to weeks after a systemic fluoroquinolone is initiated;1 have occurred in all age groups and in patients without preexisting risk factors for such adverse reactions.1

Immediately discontinue moxifloxacin at first signs or symptoms of any serious adverse reactions.1 140 145

Avoid systemic fluoroquinolones, including moxifloxacin, in patients who have experienced any of the serious adverse reactions associated with fluoroquinolones.1 140 145

Tendinitis and Tendon Rupture

Systemic fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.1 128 129

Risk of developing fluoroquinolone-associated tendinitis and tendon rupture 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 the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.1 Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any risk factors for such adverse reactions.1

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

Tendinitis and tendon rupture can occur within hours or days after moxifloxacin is initiated or as long as several months after completion of therapy and can occur bilaterally.1

Immediately discontinue moxifloxacin if pain, swelling, inflammation, or rupture of a tendon occurs.1 128 129 (See Advice to Patients.)

Avoid systemic fluoroquinolones, including moxifloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.1

Peripheral Neuropathy

Systemic fluoroquinolones, including moxifloxacin, are associated with an increased risk of peripheral neuropathy.1

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones, including moxifloxacin.1 130 Symptoms may occur soon after initiation of the drug and, in some patients, may be irreversible.1 130

Immediately discontinue moxifloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are other alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation).1 130

Avoid systemic fluoroquinolones, including moxifloxacin, in patients who have experienced peripheral neuropathy.1

CNS Effects

Systemic fluoroquinolones, including moxifloxacin, are associated with an increased risk of CNS effects.1

Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis reported with fluoroquinolones, including moxifloxacin.1 Fluoroquinolones may also cause nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts.1 These CNS effects may occur after first dose.1

If CNS effects occur, immediately discontinue moxifloxacin and institute appropriate measures.1 (See Advice to Patients.)

Use in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or with other risk factors that predispose to seizures or lower seizure threshold only if potential benefits of the drug outweigh risks.1

Avoid systemic fluoroquinolones, including moxifloxacin, in patients who have experienced CNS effects associated with fluoroquinolones.1

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including moxifloxacin, have neuromuscular blocking activity and 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 (See Advice to Patients.)

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

Other serious and sometimes fatal adverse reactions reported with fluoroquinolones, including moxifloxacin, that may or may not be related to hypersensitivity reactions include one or more of the following: 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

Immediately 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, 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

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

Other Warnings/Precautions

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 known prolonged QT interval, ventricular arrhythmias (including torsades de pointes), any ongoing proarrhythmic conditions (including clinically important bradycardia and acute myocardial ischemia), or uncorrected hypokalemia or hypomagnesemia.1

Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents or other drugs that prolong QT interval (e.g., cisapride [available in the US only under a limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants).1 (See Drugs that Prolong QT Interval under Interactions.)

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 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

Hypoglycemia or Hyperglycemia

Alterations in blood glucose concentrations, including hypoglycemia and hyperglycemia, reported with fluoroquinolones, including moxifloxacin.1 Alterations usually have occurred in elderly patients with diabetes mellitus receiving an oral antidiabetic agent (e.g., sulfonylurea agent) or insulin.1

Carefully monitor blood glucose concentrations in diabetic patients receiving antidiabetic agents and moxifloxacin concomitantly.1 If a hypoglycemic reaction occurs, discontinue moxifloxacin and initiate appropriate therapy immediately.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

Selection and Use of Anti-infectives

Use for treatment of acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.1 140 145 Because moxifloxacin, like other systemic fluoroquinolones, has been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient, risks of serious adverse reactions outweigh benefits for patients with these infections.140 145

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

Use during pregnancy only if potential benefits justify potential risks to fetus.1

No adequate and well-controlled studies in pregnant women;1 animal studies (rats) did not reveal evidence of teratogenicity.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 for any indication 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 systemic fluoroquinolones may be justified in children <18 years of age in special circumstances when there are no safe and effective alternatives and after careful assessment of the risks and benefits for the individual patient.110 292

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 Tendinitis 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;1 monitor ECGs in those with 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

Antidiabetic agents (sulfonylureas, insulin)

Alterations in blood glucose concentrations (hypoglycemia and hyperglycemia) reported1

Glyburide: No clinically important effect on glyburide pharmacokinetics1

Closely monitor blood glucose concentrations;1 if hypoglycemic reaction occurs, immediately discontinue moxifloxacin and initiate appropriate therapy1

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

Cyclosporine

No clinically important effect on pharmacokinetics of either drug1

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 not needed for either drug1

Estrogens/progestins

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 or with yogurt does not have a clinically important effect on absorption of the drug.1 83 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%

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 Active against Y. pestis in vitro and in a primate infection model.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 29 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 to read manufacturer’s patient information (medication guide) prior to initiating moxifloxacin therapy and each time prescription refilled.1

  • 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

  • Inform patients that systemic fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that may occur together in same patient.1 140 145 Advise patients to immediately discontinue moxifloxacin and contact a clinician if they experience any signs or symptoms of serious adverse effects (e.g., unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness of the arms or legs, confusion, hallucinations) while taking the drug.1 140 145 Advise patients to talk with a clinician if they have any questions or concerns.1 140 145

  • Inform patients that systemic fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups and this risk is increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients.1 Symptoms may be irreversible.1 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 or weakness or inability to use a joint) and importance of immediately discontinuing the drug and contacting a clinician.1 (See Tendinitis and Tendon Rupture under Cautions.)

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

  • Inform patients that systemic fluoroquinolones, including moxifloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure).1 Importance of informing clinician of any history of epilepsy or seizures before initiating therapy with the drug.1 Importance of contacting a clinician if persistent headache with or without blurred vision occurs.1

  • Advise patients that moxifloxacin may cause dizziness and lightheadedness;1 caution patients not to engage in activities requiring mental alertness and motor coordination (e.g., driving a vehicle, operating machinery) until effects of the drug on the individual are known.1

  • Advise patients that systemic fluoroquinolones, including moxifloxacin, may worsen myasthenia gravis symptoms;1 importance of informing clinician of any history of myasthenia gravis.1 Importance of immediately contacting a clinician if any symptoms of muscle weakness, including respiratory difficulties, occur.1

  • Inform patients that moxifloxacin may be associated with hypersensitivity reactions (including anaphylactic reactions), even after first dose.1 Importance of immediately discontinuing moxifloxacin and contacting a clinician at first sign of rash, hives or other skin reaction, rapid heartbeat, difficulty swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of lips, tongue, face; throat tightness; hoarseness), jaundice, or any other sign of hypersensitivity.1

  • Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients 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 Importance of discontinuing moxifloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs.1

  • Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) reported in patients receiving moxifloxacin.1 Importance of informing a clinician if any signs or symptoms of liver injury (e.g., loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements, dark colored urine) occur.1

  • Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia) and of concurrent therapy with any drugs that may affect QT interval (e.g., class IA [quinidine, procainamide] or class III [e.g., amiodarone, sotalol] antiarrhythmic agents).1 Importance of contacting a clinician if symptoms of prolonged QT interval (e.g., prolonged heart palpitations, loss of consciousness) occur.1

  • Advise patients with diabetes mellitus receiving an oral antidiabetic agent or insulin that fluoroquinolones, including moxifloxacin, may cause alterations in blood glucose concentrations (hypoglycemia or hyperglycemia).1 Importance of discontinuing moxifloxacin and contacting a clinician if a hypoglycemic reaction occurs.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 (e.g., drugs that may affect QT interval), as well as any concomitant illnesses.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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Moxifloxacin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

400 mg of (of moxifloxacin)*

Avelox

Bayer

Moxifloxacin Hydrochloride Tablets

Parenteral

Injection, for IV infusion

400 mg (of moxifloxacin) in 0.8% sodium chloride*

Avelox I.V.

Bayer

Moxifloxacin Hydrochloride Injection for IV Infusion

AHFS DI Essentials. © Copyright 2017, Selected Revisions October 4, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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

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