(moxs i FLOKS a sin)
- Moxifloxacin HCl
- Moxifloxacin Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Avelox: 400 mg/250 mL (250 mL)
Generic: 400 mg/250 mL (250 mL)
Solution, Intravenous [preservative free]:
Avelox: 400 mg/250 mL (250 mL [DSC]) [latex free]
Generic: 400 mg/250 mL (250 mL)
Avelox: 400 mg
Avelox ABC Pack: 400 mg [DSC]
Generic: 400 mg
Brand Names: U.S.
- Avelox ABC Pack [DSC]
- Antibiotic, Fluoroquinolone
- Antibiotic, Respiratory Fluoroquinolone
Moxifloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; inhibition is bactericidal.
Well absorbed; not affected by high-fat meal or yogurt
Vd: 1.7 to 2.7 L/kg; tissue concentrations often exceed plasma concentrations in respiratory tissues, alveolar macrophages, abdominal tissues/fluids, uterine tissue (endometrium, myometrium), and sinus tissues
Hepatic (~52% of dose) via glucuronide (~14%) and sulfate (~38%) conjugation
Urine (as unchanged drug [20%] and glucuronide conjugates); feces (as unchanged drug [25%] and sulfate conjugates)
Single dose: Oral: 12-16 hours; IV: 8-15 hours
~30% to 50%
Use: Labeled Indications
Treatment of mild to moderate community-acquired pneumonia, including multidrug-resistant Streptococcus pneumoniae (MDRSP); acute bacterial exacerbation of chronic bronchitis; acute bacterial sinusitis; complicated and uncomplicated skin and skin structure infections; complicated intra-abdominal infections; prophylaxis and treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis.
Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve moxifloxacin for use in patients who have no alternative treatment options for acute exacerbation of chronic bronchitis or acute sinusitis.
Off Label Uses
Based on the Centers for Disease Control and Prevention (CDC) Expert Panel Meetings on Prevention and Treatment of Anthrax in Adults, moxifloxacin is as an effective and recommended agent for the treatment of cutaneous anthrax and an alternative agent for postexposure prophylaxis and treatment of systemic anthrax (with or without possible/confirmed meningitis).
Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of bacterial meningitis, moxifloxacin is an effective and recommended alternative agent for the treatment of penicillin-resistant Streptococcus pneumoniae meningitis.
Bite wounds (animal/human)
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), moxifloxacin is an effective and recommended alternative option for treatment of bite wounds, particularly in patients with a human bite wound who are hypersensitive to beta-lactams.
Diabetic foot infections
Based on the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of diabetic foot infections, moxifloxacin is an effective and recommended treatment option for moderate to severe diabetic foot infections.
Noncontrolled trials support the use of moxifloxacin as alternative treatment in patients with persistent detection of Mycoplasma genitalium who have not responded to or are intolerant of azithromycin.
Centers for Disease Control and Prevention (CDC) guidelines for treatment of sexually transmitted diseases (STDs) state that moxifloxacin is the preferred second-line agent for urethritis, cervicitis, or pelvic inflammatory disease (PID) in patients resistant to azithromycin and/or with persistent detection of M. genitalium.
Data from a limited number of patients studied suggest that moxifloxacin, with or without other antimicrobials, may be beneficial for the treatment of infections caused by susceptible Nocardia spp. [Fihman 2006], [Kandasamy 2008], [Tripodi 2011]. Additional data may be necessary to further define the role of moxifloxacin in this condition.
Pelvic inflammatory disease
Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, moxifloxacin may be considered as alternative treatment in patients allergic to cephalosporins with pelvic inflammatory disease. The CDC recommends use as an alternative therapy only if standard parenteral cephalosporin therapy is not feasible and community prevalence of quinolone-resistant gonococcal organisms is low. Culture sensitivity must be confirmed.
Based on the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society of Healthcare Epidemiology of America (SHEA) guidelines for antimicrobial prophylaxis in surgery, moxifloxacin (systemic) may be administered (in combination with either clindamycin or vancomycin) as an alternative regimen in patients with beta-lactam allergy.
Tuberculosis (second-line therapy)
Based on the American Thoracic Society, Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) Treatment of Tuberculosis guidelines, moxifloxacin (systemic) given for second-line therapy of tuberculosis is effective and recommended in the management of this condition.
Additional Off-Label Uses
Community-acquired pneumonia (CAP) (mild-to-moderate), including multidrug-resistant Streptococcus pneumoniae (MDRSP) in adolescents with skeletal maturity
Hypersensitivity to moxifloxacin, other quinolone antibiotics, or any component of the formulation
Acute bacterial rhinosinusitis: Oral, IV: 400 mg every 24 hours for 10 days (manufacturer’s labeling) or 5 to 7 days (Chow 2012). Note: Recommended in patients with beta-lactam allergy; may also be used if initial therapy fails, in areas with high endemic rates of penicillin nonsusceptible S. pneumoniae, those with severe infections, age >65 years, recent hospitalization, antibiotic use within the past month, or who are immunocompromised.
Anthrax (off-label use) (CDC [Hendricks 2014]):
Inhalational (postexposure prophylaxis): Oral: 400 mg every 24 hours for 60 days
Cutaneous (without systemic involvement): Oral: 400 mg every 24 hours for 7 to 10 days for naturally acquired infection; 60 days for bioterrorism-related cases
Systemic (including meningitis), treatment: IV: 400 mg every 24 hours; use in combination with a protein synthesis inhibitor (eg, clindamycin, linezolid); if meningitis is suspected or cannot be ruled out, use in combination with another bactericidal antimicrobial (eg, beta-lactam) and a protein synthesis inhibitor (eg, clindamycin, linezolid). Duration of therapy is 2 weeks or until clinically stable when meningitis has been excluded; ≥2 to 3 weeks for possible/confirmed meningitis. Patients exposed to aerosolized spores require prophylaxis to complete an antimicrobial course of 60 days from illness onset.
Bacterial meningitis (off-label use): IV: 400 mg every 24 hours for 10 to 14 days (IDSA [Tunkel 2004])
Bite wounds (animal/human) (off-label use): Oral, IV: Note: Recommended as an alternative therapy for human bite wound in patients hypersensitive to beta-lactams: 400 mg once daily (IDSA [Stevens 2014])
Chronic bronchitis, acute bacterial exacerbation: Oral, IV: 400 mg every 24 hours for 5 days
Community-acquired pneumonia (CAP) (including MDRSP): Oral, IV:
Manufacturer’s labeling: 400 mg every 24 hours for 7 to 14 days
Alternate dosing: 400 mg every 24 hours for 5 days (IDSA [Mandell 2007])
Diabetic foot infection (off-label use): Oral, IV: 400 mg once daily (Vick-Fragoso 2009)
Intra-abdominal infections, complicated: Oral, IV: 400 mg every 24 hours for 5 to 14 days (initiate with IV); Note: 2010 IDSA guidelines recommend a treatment duration of 4 to 7 days (provided source controlled) for community-acquired, mild to moderate IAI
Mycoplasma genitalium (off-label use): Oral: 400 mg every 24 hours for 7, 10, or 14 days (Bissessor 2015; CDC [Workowski 2015])
Nocardiosis (off-label use): Oral, IV: 400 mg once daily; may be used in combination with other antimicrobials (Fihman 2006; Kandasamy 2008; Tripodi 2011). Additional data may be necessary to further define the role of moxifloxacin in this condition.
Pelvic inflammatory disease (in patients allergic to cephalosporins) (off-label use): Oral: 400 mg every 24 hours for 14 days. Note: The CDC recommends use as an alternative therapy only if standard parenteral cephalosporin therapy is not feasible and community prevalence of quinolone-resistant gonococcal organisms is low. Culture sensitivity must be confirmed (CDC [Workowski 2015])
Plague: Oral, IV: 400 mg every 24 hours for 10 to 14 days
Skin and skin structure infections: Oral, IV:
Complicated: 400 mg every 24 hours for 7 to 21 days
Uncomplicated: 400 mg every 24 hours for 7 days
Surgical (perioperative) prophylaxis (off-label use): IV: 400 mg within 120 minutes prior to surgical incision (Bratzler 2013).
Tuberculosis, drug-resistant tuberculosis, or intolerance to first-line agents (off-label use): Oral: 400 mg every 24 hours (CDC 2003)
Refer to adult dosing.
Community-acquired pneumonia (CAP) due to atypical pathogens (M. pneumoniae, Chlamydophila [also known as Chlamydia] pneumoniae, C. trachomatis), mild infection or step-down therapy in adolescents with skeletal maturity, (alternative to azithromycin) (IDSA/PIDS 2011) (off-label use): Adolescents: Oral: 400 mg once daily
Surgical (perioperative) prophylaxis (off-label use): Children ≥1 year and Adolescents: IV: 10 mg/kg within 120 minutes prior to surgical incision (maximum dose: 400 mg) (Bratzler 2013)
Dosing: Renal Impairment
No dosage adjustment necessary.
Poorly dialyzed; no supplemental dose or dosage adjustment necessary, including patients on intermittent hemodialysis, peritoneal dialysis, or continuous renal replacement therapy (eg, CVVHD).
Dosing: Hepatic Impairment
No dosage adjustment necessary; however, use with caution in this patient population secondary to the risk of QT prolongation.
A 20 mg/mL oral suspension may be made using tablets. Crush three 400 mg tablets and reduce to a fine powder. Carefully sieve powder from enteric-coating remnants to improve pharmaceutical elegance. Add a small amount of a 1:1 mixture of Ora-Plus® and Ora-Sweet® or Ora-Sweet® SF and mix to a uniform paste; mix while adding the vehicle in geometric proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Label "shake well". Stable 90 days at room temperature.Hutchinson DJ, Johnson CE, and Klein KC, "Stability of Extemporaneously Prepared Moxifloxacin Oral Suspensions," Am J Health Syst Pharm, 2009, 66(7):665-7.19299374
Oral: Administer without regard to meals. Administer at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron, or zinc, including antacids, sucralfate, multivitamins, and didanosine (buffered tablets for oral suspension or the pediatric powder for oral solution).
IV: Infuse over 60 minutes; do not infuse by rapid or bolus intravenous infusion.
Avelox IV infusion (premixed in sodium chloride 0.8%) contains sodium 34.2 mEq (~787 mg)/250 mL.
Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Avoid high humidity. Do not refrigerate infusion solution; discard unused portion.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy
Antacids: May decrease the absorption of Quinolones. Of concern only with oral administration of quinolones. Exceptions: Sodium Bicarbonate. Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Blood Glucose Lowering Agents: Quinolones may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy
Delamanid: Moxifloxacin (Systemic) may enhance the QTc-prolonging effect of Delamanid. Avoid combination
Didanosine: Quinolones may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Consider therapy modification
Heroin: Quinolones may enhance the adverse/toxic effect of Heroin. Monitor therapy
Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Iron Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, oflox-, pefloxacin, or nalidixic acid) oral iron salts Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Consider therapy modification
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Lanthanum: May decrease the serum concentration of Quinolones. Management: Administer oral quinolone antibiotics at least one hour before or four hours after lanthanum. Consider therapy modification
Macimorelin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Magnesium Salts: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Consider therapy modification
Mequitazine: Moxifloxacin (Systemic) may enhance the arrhythmogenic effect of Mequitazine. Avoid combination
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolones. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Consider therapy modification
Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolones. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Consider therapy modification
Mycophenolate: Quinolones may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Monitor therapy
Nadifloxacin: May enhance the adverse/toxic effect of Quinolones. Avoid combination
Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy
Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
QTc-Prolonging Agents (Highest Risk): QTc-Prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination
QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy
QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Moderate Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Quinapril: May decrease the serum concentration of Quinolones. Management: Separate doses of quinapril and oral quinolones by at least 2 hours in order to reduce the risk of interaction. Monitor for reduced efficacy of the quinolone if these products are used concomitantly. Consider therapy modification
Sevelamer: May decrease the absorption of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Strontium Ranelate: May decrease the serum concentration of Quinolones. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Avoid combination
Sucralfate: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after the sucralfate dose. Greater separation of doses may further lessen the risk for a significant interaction. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Varenicline: Quinolones may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concurrent use of levofloxacin or other quinolone antibiotics, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy
Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination
Vitamin K Antagonists (eg, warfarin): Quinolones may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Xipamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy
Zinc Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Exceptions: Zinc Chloride. Consider therapy modification
Some quinolones may produce a false-positive urine screening result for opioids using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opioid screens by more specific methods should be considered.
2% to 10%:
Central nervous system: Headache (≤4%), dizziness (3%), insomnia (2%)
Endocrine & metabolic: Decreased serum glucose (≥2%), hyperchloremia (≥2%), increased serum albumin (≥2%)
Gastrointestinal: Nausea (7%), diarrhea (6%), decreased amylase (≥2%), constipation (2%), vomiting (2%), abdominal pain (1% to 2%)
Hematologic & oncologic: Decreased basophils (≥2%), decreased hemoglobin (≥2%), decreased neutrophils (≥2%), decreased prothrombin time (≥2%), decreased red blood cells (≥2%), eosinopenia (≥2%), increased MCH (≥2%), increased neutrophils (≥2%), leukocytosis (≥2%), prolonged prothrombin time (≥2%)
Hepatic: Decreased serum bilirubin (≥2%), increased serum bilirubin (≥2%)
Immunologic: Increased serum globulins (≥2%)
Renal: Increased ionized serum calcium (≥2%)
Respiratory: Hypoxia (≥2%)
0.1% to <2%:
Cardiovascular: Angina pectoris, atrial fibrillation, bradycardia, cardiac arrest, cardiac failure, chest discomfort, chest pain, edema, hypertension, hypotension, increased blood pressure, palpitations, peripheral edema, phlebitis, prolonged Q-T interval on ECG, syncope, tachycardia
Central nervous system: Agitation, anxiety, chills, confusion, depression, disorientation, drowsiness, facial pain, fatigue, hallucination, hypoesthesia, lethargy, malaise, nervousness, noncardiac chest pain, pain, paresthesia, restlessness, vertigo
Dermatologic: Allergic dermatitis, erythema, hyperhidrosis, night sweats, pruritus, skin rash, urticaria
Endocrine & metabolic: Hypokalemia (1%), dehydration, hyperglycemia, hyperlipidemia, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum glucose, increased serum triglycerides, increased uric acid
Gastrointestinal: Dyspepsia (1%), abdominal discomfort, abdominal distension, anorexia, decreased appetite, dysgeusia, flatulence, gastritis, gastroenteritis, gastroesophageal reflux disease, increased amylase, increased serum lipase, oral candidiasis, xerostomia
Genitourinary: Dysuria, fungal vaginosis, vaginal infection, vulvovaginal candidiasis, vulvovaginal pruritus
Hematologic & oncologic: Anemia (1%), decreased hematocrit, eosinophilia, leukopenia, prolonged partial thromboplastin time, thrombocythemia, thrombocytopenia
Hepatic: Increased serum ALT (1%), abnormal hepatic function tests, increased liver enzymes, increased serum alkaline phosphatase, increased serum AST, increased serum transaminases
Hypersensitivity: Hypersensitivity reaction
Infection: Candidiasis, fungal infection (including oral)
Neuromuscular & skeletal: Arthralgia, back pain, limb pain, muscle spasms, musculoskeletal pain, myalgia, tremor, weakness
Ophthalmic: Blurred vision
Renal: Increased blood urea nitrogen, increased serum creatinine, renal failure
Respiratory: Asthma, bronchospasm, dyspnea, wheezing
Miscellaneous: Fever (1%)
<0.1%, postmarketing, and/or case reports: Abnormal gait, agranulocytosis, anaphylactic shock, anaphylaxis, angioedema, aplastic anemia, ataxia, auditory impairment, cholestatic jaundice, Clostridium difficile associated diarrhea, deafness (reversible), decreased INR, ECG abnormality, exacerbation of myasthenia gravis, facial edema, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis (predominantly cholestatic), hepatotoxicity (idiosyncratic) (Chalasani 2014), hypoglycemia, increased intracranial pressure, interstitial nephritis, jaundice, laryngeal edema, myasthenia, nightmares, pancytopenia, paranoia, peripheral neuropathy (may be irreversible), pharyngeal edema, phototoxicity, pneumonitis (allergic), polyneuropathy, pseudomembranous colitis, pseudotumor cerebri, psychotic reaction, renal insufficiency, rupture of tendon, seizure, serum sickness, skin photosensitivity, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, tendonitis, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, ventricular tachyarrhythmias (including torsades de pointes and cardiac arrest [usually in patients with concurrent, severe proarrhythmic conditions]), vasculitis, vision loss (transient)
Concerns related to adverse effects:
• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with known QTc prolongation, ventricular arrhythmias including torsades de pointes, proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial ischemia), uncorrected hypokalemia, hypomagnesemia, or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).
• Glucose regulation: Fluoroquinolones have been associated with the development of serious, and sometimes fatal, hypoglycemia. These events have occurred most often in elderly patients with diabetes, but have also been reported in patients without a prior history of diabetes. Prompt identification and treatment of hypoglycemia is essential. Individual quinolones may differ in their potential to cause this effect. It was most evident with gatifloxacin (no longer marketed as s systemic formulation). Hyperglycemia has also been associated with the use of fluoroquinolones. Patients should be monitored closely for signs/symptoms of disordered glucose regulation.
• Hepatotoxicity: Fulminant hepatitis potentially leading to liver failure (including fatalities) has been reported with use; patients should be advised to discontinue treatment and promptly report signs/ symptoms of hepatitis (eg, abdominal pain, jaundice, dark urine, pale stools).
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.
• Photosensitivity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may rarely cause moderate to severe phototoxicity reactions. Discontinue use if phototoxicity occurs.
• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue moxifloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without pre-existing risk factors have experienced these reactions; may occur within hours to weeks after initiation.
- CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis; may also cause nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or actions. May occur following the first dose; discontinue immediately and avoid further use of fluoroquinolones in patients who experience these reactions. Use with caution in patients with known or suspected CNS disorder, or risk factors that may predispose to seizures or lower the seizure threshold.
- Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy.
- Tendinitis/tendon rupture: Fluoroquinolones have been associated with an increased risk of tendonitis and tendon rupture in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant recipients, and in patients >60 years of age, but has also occurred in patients without these risk factors. Rupture of the Achilles tendon has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Inflammation and rupture may occur bilaterally. Cases have been reported within hours or days of initiation, and up to several months after discontinuation of therapy. Strenuous physical activity, renal failure, and previous tendon disorders may be independent risk factor for tendon rupture. Discontinue at first sign of tendon pain, swelling, inflammation or rupture. Avoid use in patients with a history of tendon disorders or who have experienced tendinitis or tendon rupture.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Cardiovascular disease: Use with caution in patients with significant bradycardia or acute myocardial ischemia.
• Diabetes: Use with caution in patients with diabetes mellitus; glucose regulation may be altered.
• Hepatic impairment: Use with caution in patients with mild, moderate, or severe hepatic impairment or liver cirrhosis; may increase the risk of QT prolongation.
• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support, and deaths have been reported.
• Renal impairment: Use with caution in patients with renal failure; may increase risk of tendon rupture.
• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in elderly patients.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with latent or actual G6PD deficiency.
• Pediatric: Efficacy of systemically administered moxifloxacin (oral, intravenous) have not been established in pediatric patients.
• Appropriate use: [US Boxed Warning]: Reserve use of moxifloxacin for treatment of acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis for patients who have no alternative treatment options because of the risk of disabling and potentially serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects).
WBC, signs of infection, signs/symptoms of disordered glucose regulation, ECG in patients with liver cirrhosis
Adverse events have been observed in some animal reproduction studies. Moxifloxacin crosses the placenta and can be detected in the amniotic fluid and cord blood (Ozyüncü and Beksac 2010; Ozyüncü and Nemutlu, 2010). Information specific to moxifloxacin use in pregnant women is limited (Padberg, 2014).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience nausea or diarrhea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), signs of nerve problems (sensitivity to heat or cold; decreased sense of touch; burning, numbness, or tingling; pain, or weakness in the arms, hands, legs, or feet), signs of tendon inflammation or rupture (pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), angina, tachycardia, abnormal heartbeat, passing out, dizziness, tinnitus, chills, muscle pain, muscle weakness, nightmares, agitation, hallucinations, nightmares, seizures, severe headache, shortness of breath, bruising, bleeding, tremors, insomnia, abnormal gait, vaginitis, thrush, vision changes, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
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