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Moxifloxacin (Systemic)

Pronunciation

Pronunciation

(moxs i FLOKS a sin)

Index Terms

  • Moxifloxacin HCl
  • Moxifloxacin Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Generic: 400 mg/250 mL (250 mL)

Solution, Intravenous [preservative free]:

Avelox: 400 mg/250 mL (250 mL) [latex free]

Tablet, Oral:

Avelox: 400 mg

Avelox ABC Pack: 400 mg

Generic: 400 mg

Brand Names: U.S.

  • Avelox
  • Avelox ABC Pack

Pharmacologic Category

  • Antibiotic, Fluoroquinolone
  • Antibiotic, Respiratory Fluoroquinolone

Pharmacology

Moxifloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; inhibition is bactericidal.

Absorption

Well absorbed; not affected by high-fat meal or yogurt

Distribution

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

Metabolism

Hepatic (~52% of dose) via glucuronide (~14%) and sulfate (~38%) conjugation

Excretion

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

Half-Life Elimination

Single dose: Oral: 12-16 hours; IV: 8-15 hours

Protein Binding

~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.

Use: Unlabeled

Treatment of Legionella pneumonia; treatment of mild-to-moderate community-acquired pneumonia (CAP), including multidrug-resistant Streptococcus pneumoniae (MDRSP) in adolescents with skeletal maturity; tuberculosis (second-line therapy); surgical (perioperative) prophylaxis

Contraindications

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

Dosing: Adult

Acute bacterial rhinosinusitis: Oral, IV: 400 mg every 24 hours for 10 days 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.

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):

Manufacturer’s labeling: 400 mg every 24 hours for 7 to 14 days

Alternate dosing (off label regimen): 400 mg every 24 hours for 5 days (IDSA [Mandell 2007])

Intra-abdominal infections, complicated: 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])

Pelvic inflammatory disease (in patients allergic to cephalosporins; off-label use): Oral: 400 mg every 24 hours (in combination with metronidazole) 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 (MMWR 2003)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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): Adolescents (off-label): Oral: 400 mg once daily

Surgical (perioperative) prophylaxis (off-label use): Children ≥1 year: IV: 10 mg/kg within 120 minutes prior to surgical incision (maximum dose: 400 mg) (Bratzler 2013)

Dosing: Renal Impairment

No dosage adjustment required in renal impairment.

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 is required in mild, moderate, or severe hepatic insufficiency (Child-Pugh class A, B, or C); however, use with caution in this patient population secondary to the risk of QT prolongation.

Extemporaneously Prepared

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

Administration

Administer without regard to meals.

IV: Infuse over 60 minutes; do not infuse by rapid or bolus intravenous infusion

Dietary Considerations

Take 4 hours before or 8 hours after multiple vitamins, antacids, or other products containing magnesium, aluminum, iron, or zinc.

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

Compatibility

Stable in NS, D5W, D10W, SWFI, LR; do not add other medications to intravenous solution.

Y-site administration: Incompatible with pantoprazole.

Storage

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.

Drug Interactions

Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy

Antacids: May decrease the absorption of Quinolone Antibiotics. 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: Quinolone Antibiotics may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics 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 Quinolone Antibiotics. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

Didanosine: Quinolone Antibiotics may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolone Antibiotics. 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

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Iron Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer 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-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral iron salts. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification

Ivabradine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Lanthanum: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolone antibiotics at least two hours before or after lanthanum. Consider therapy modification

Magnesium Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer 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-, 4 h for lome-, 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 Moderate Risk QTc-Prolonging Agents. Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate Risk QTc-Prolonging Agents. 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

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolone Antibiotics. 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 Quinolone Antibiotics. 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: Quinolone Antibiotics 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 Quinolone Antibiotics. Avoid combination

Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolone Antibiotics. Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Quinapril: May decrease the serum concentration of Quinolone Antibiotics. 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 Quinolone Antibiotics. 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 Quinolone Antibiotics. 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 Quinolone Antibiotics. 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: Quinolone Antibiotics 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 Moderate Risk QTc-Prolonging Agents. Avoid combination

Vitamin K Antagonists (eg, warfarin): Quinolone Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Zinc Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer 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-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral zinc salts. Exceptions: Zinc Chloride. Consider therapy modification

Test Interactions

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.

Adverse Reactions

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)

Local: Extravasation

Neuromuscular & skeletal: Arthralgia, back pain, limb pain, muscle spasms, musculoskeletal pain, myalgia, tremor, weakness

Ophthalmic: Blurred vision

Otic: Tinnitus

Renal: Increased blood urea nitrogen, increased serum creatinine, renal failure

Respiratory: Asthma, bronchospasm, dyspnea, wheezing

Miscellaneous: Fever (1%)

<0.1% (Limited to important or life-threatening): Agranulocytosis, anaphylactic shock, anaphylaxis, aplastic anemia, ataxia, auditory impairment, cholestatic jaundice, Clostridium difficile associated diarrhea, deafness (reversible), decreased INR, ECG abnormality, exacerbation of myasthenia gravis, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis (predominantly cholestatic), hepatotoxicity (idiosyncratic) (Chalasani 2014), hypoglycemia, increased intracranial pressure, interstitial nephritis, jaundice, pancytopenia, peripheral neuropathy (may be irreversible), phototoxicity, pneumonitis (allergic), polyneuropathy, pseudomembranous colitis, pseudotumor cerebri, psychotic reaction, renal insufficiency, rupture of tendon, seizure, skin photosensitivity, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, tendonitis, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, ventricular tachyarrhythmias (including torsade de pointes and cardiac arrest [usually in patients with concurrent, severe proarrhythmic conditions]), vasculitis, vision loss (transient)

ALERT: U.S. Boxed Warning

Serious adverse reactions:

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Because fluoroquinolones have been associated with serious adverse reactions, reserve moxifloxacin for use in patients who have no alternative treatment options for the following indications: acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis.

Myasthenia gravis:

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

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with known QTc prolongation, ventricular arrhythmias including torsades de pointes, proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial ischemia), uncorrected hypokalemia, hypomagnesemia, or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).

• 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.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with significant bradycardia or acute myocardial ischemia.

• Diabetes: Use with caution in patients with diabetes mellitus; glucose regulation may be altered.

• Hepatic impairment: Use with caution in patients with mild, moderate, or severe hepatic impairment or liver cirrhosis; may increase the risk of QT prolongation.

• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support, and deaths have been reported.

• Renal impairment: Use with caution in patients with renal failure; may increase risk of tendon rupture.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.

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.

Special populations:

• 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: Safety and efficacy of systemically administered moxifloxacin (oral, intravenous) have not been established in children.

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Reserve use of moxifloxacin for treatment of acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis for patients who have no alternative treatment options because of the risk of disabling and potentially serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects).

Monitoring Parameters

WBC, signs of infection, signs/symptoms of disordered glucose regulation, blood glucose in diabetic patients, ECG in patients with liver cirrhosis

Pregnancy Risk Factor

C

Pregnancy Considerations

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).

Patient Education

• 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, dizziness, tinnitus, chills, muscle pain, muscle weakness, 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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