MOXIFLOXACIN HYDROCHLORIDE 
Pronounciation
Trade Name(s)
- Avelox
Baseline studies indicated; see Monitor. See Maternal/Child.
400 mg once every 24 hours. Duration of therapy is based on diagnosis as listed in the following chart. Serum levels similar by oral or IV route. Transfer to oral therapy as soon as practical; no dose adjustment necessary. The magnitude of QT prolongation may increase with increasing serum concentrations. Do not exceed recommended dose.
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Dose adjustment is not indicated based on age, gender, or race; in impaired renal function (including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)); or in mild, moderate, or severe impaired hepatic function (Child-Pugh Classes A, B, and C). See Precautions.
Available in ready-to-use, latex-free flexibags containing 400 mg moxifloxacin in 0.8% saline. No further dilution is necessary. Refer to directions provided with administration set.
No data available from manufacturer.
Store at CRT. Do not refrigerate; a precipitate will form. Discard unused portions.
Limited compatibility data available. Manufacturer states, “Other IV substances, additives, or other medications should not be added to moxifloxacin or infused simultaneously through the same IV line.” Flush line with a solution compatible to both drugs before and after administration of moxifloxacin and/or any other drug through the same IV line. May be administered through a Y-tube. Temporarily discontinue other solutions infusing at the same site.
Manufacturer lists as compatible with NS, D5W, D10W, SWFI, LR at ratios from 1∶10 to 10∶1.
Other sources suggest a few specific compatibilities dependent on concentration and manufacturer; consult a pharmacist.
Single dose equally distributed over 60 minutes as an infusion. Avoid rapid or bolus IV infusion. Incidence and magnitude of QT prolongation may increase with increasing concentrations or increasing rates of infusion. Do not exceed the recommended rate of infusion. Flush tubing before and after moxifloxacin with a compatible solution.
A synthetic broad-spectrum fluoroquinolone antibacterial agent. Effective against a wide range of gram-negative and gram-positive organisms, including common respiratory pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, and atypicals such as Chlamydophila pneumoniae and Mycoplasma pneumoniae. Bactericidal action results from inhibition of topoisomerase II and IV, which are required for bacterial DNA replication, transcription, repair, and recombination. Mechanism of action of fluoroquinolones differs from that of aminoglycosides, cephalosporins, macrolides, beta-lactams, and tetracyclines, and fluoroquinolones may be active against pathogens resistant to these antibiotics. There is no cross-resistance between fluoroquinolones and these other antibiotics. Widely distributed throughout the body. Concentrations in most target tissues are higher than those found in plasma. Mean half-life is approximately 8.5 to 17 hours. Partially metabolized in the liver by glucuronide and sulfate conjugation. Excreted as unchanged drug and metabolites in feces and urine. May be secreted in breast milk.
Treatment of adults with infections caused by susceptible strains of designated microorganisms in conditions listed in this section.
■ Treatment of community-acquired pneumonia caused by many organisms, including S. pneumoniae (including multidrug-resistant strains [MDRSP]). MDRSP strains are resistant to two or more of the following antibiotics: penicillin, second-generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and sulfamethoxazole/trimethoprim.
■ Treatment of complicated and uncomplicated skin and skin structure infections.
■ Treatment of complicated intra-abdominal infections, including polymicrobial infections such as abscess.
■ Treatment of the plague, including pneumonic and septicemic plague, and prophylaxis of plague in adult patients.
■ Treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) and acute bacterial sinusitis (ABS). Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions and because for some patients ABECB and ABS are self-limiting, reserve moxifloxacin for treatment in patients who have no alternative treatment options.
History of hypersensitivity to moxifloxacin or other quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin).
For IV use only.
■ To reduce the development of drug-resistant bacteria and maintain its effectiveness, moxifloxacin should be used to treat or prevent only those infections proven or strongly suspected to be caused by bacteria.
■ C/S studies indicated to determine susceptibility of the causative organism to moxifloxacin.
■ Cross-resistance has been observed between moxifloxacin and other fluoroquinolones against gram-negative bacteria. However, gram-positive bacteria resistant to other fluoroquinolones may still be susceptible to moxifloxacin.
■ Observed emergence of bacterial resistance to fluoroquinolones and the occurrence of cross-resistance with other fluoroquinolones are of concern. Proper use of fluoroquinolones and other classes of antibiotics is encouraged to avoid the emergence of resistant bacteria from overuse.
■ Prolonged use may cause superinfection because of overgrowth of nonsusceptible organisms.
■ Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together in the same patient. Commonly seen adverse reactions include tendinitis and tendon rupture, arthralgia, myalgia, peripheral neuropathy, and CNS effects (e.g., anxiety, confusion, depression, hallucinations, insomnia, severe headaches). These reactions can occur within hours to weeks after starting moxifloxacin and have been seen in patients of any age and in patients without any pre-existing risk factors. Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions.
■ Prolongation of the QT interval on ECG and infrequent cases of arrhythmia (including torsades de pointes) have been reported. The risk of arrhythmia may be reduced by avoiding the use of moxifloxacin in patients with known prolongation of the QT interval, uncorrected electrolyte imbalances (e.g., hypokalemia, hypomagnesemia), significant bradycardia, cardiomyopathy, ventricular arrhythmias (including torsade de pointes), myocardial ischemia, or in patients being treated with Class Ia antiarrhythmic agents (e.g., quinidine, procainamide) or Class III antiarrhythmic agents (e.g., amiodarone, sotalol) or any other drug that can prolong the QT interval; see Drug/Lab Interactions.
■ Use caution in patients with mild, moderate, or severe hepatic insufficiency; associated metabolic disturbances may lead to QT prolongation.
■ Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudo-tumor cerebri), tremors, and light-headedness. May trigger seizures or lower the seizure threshold. Use caution in patients with epilepsy or known or suspected CNS disorders that may predispose patients to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, previous history of convulsions, reduced cerebral blood flow, altered brain structure, or stroke) or in the presence of other risk factors that may predispose patients to seizures (e.g., drugs that may lower the seizure threshold, renal dysfunction).
■ Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of psychiatric adverse reactions, including toxic psychosis; psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious behavior such as attempted or completed suicide; anxiety, agitation, restlessness, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; and memory impairment. These reactions may occur after the first dose.
■ Tendinitis and tendon rupture that required surgical repair or resulted in prolonged disability have been reported in patients of all ages receiving quinolones. Most frequently involves the Achilles tendon but has also been reported with the shoulder, hand, biceps, thumb, and other tendon sites.
■ Tendinitis or tendon rupture may occur during or for up to months after fluoroquinolone therapy and may occur bilaterally. Risk may be increased in patients over 60 years of age; in patients taking corticosteroids; in patients with heart, kidney, or lung transplants; with strenuous physical activity; and in patients with renal failure or previous tendon disorders such as rheumatoid arthritis. Avoid moxifloxacin in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture. Discontinue moxifloxacin immediately if patient experiences pain, swelling, inflammation, or rupture of a tendon.
■ Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Serious adverse events, including requirement for ventilatory support and deaths, have been reported in these patients. Avoid use in patients with a known history of myasthenia gravis.
■ Fluoroquinolones, including moxifloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias (impairment of sensitivity or touch), or weakness have been reported. Symptoms may occur soon after initiation of therapy and may be irreversible. Avoid moxifloxacin in patients who have previously experienced peripheral neuropathy.
■ Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported. Often occur after the first dose.
■ Other serious events (sometimes fatal) due to hypersensitivity or uncertain etiology have been reported with fluoroquinolones, including moxifloxacin. Usually occur following multiple doses. Manifestations may include things such as allergic pneumonitis, renal impairment/failure, hematologic toxicity, hepatic necrosis/failure, vasculitis, and dermatologic toxicity; see Side Effects, Post-Marketing. Discontinue moxifloxacin at the first appearance of a skin rash, jaundice, or other signs of hepatotoxicity or hypersensitivity.
■ Epidemiologic studies report an increased rate of aortic aneurysm and dissection within 2 months after use of fluoroquinolones, particularly in elderly patients. In patients with a known aortic aneurysm or in patients who are at greater risk for aortic aneurysms, moxifloxacin use should be limited to those cases in which no alternative antibacterial treatments are available.
■ Fluoroquinolones, including moxifloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in patients with diabetes who are receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide [DiaBeta]) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported.
■ Moderate to severe photosensitivity/phototoxicity reactions have been reported in patients receiving quinolones; see Patient Education.
■ Clostridium difficile–associated diarrhea (CDAD) has been reported. May range from mild diarrhea to fatal colitis. Due to the potential serious side effects, the FDA recommends not to use fluoroquinolones if other options are available.
■ See Monitor.
Obtain baseline and periodic CBC with differential and blood glucose.
■ Monitor for S/S of a hypersensitivity reaction (e.g., cardiovascular collapse, dyspnea, itching, loss of consciousness, pharyngeal or facial edema, tingling, urticaria). May be seen with first or subsequent doses. Emergency equipment must be readily available; see Side Effects.
■ Monitor for S/S of peripheral neuropathy. Discontinue moxifloxacin at first symptoms of neuropathy (e.g., pain, burning, tingling, numbness and/or weakness) or if patient has deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength.
■ ECG monitoring for QT prolongation may be indicated in select patients.
■ Monitor for CNS adverse effects, including altered mental status, seizures, and changes in mood or behavior.
■ Monitor for S/S of tendinitis or tendon rupture.
■ Maintain adequate hydration to prevent concentrated urine throughout treatment. Other quinolones have formed crystals.
■ Monitor blood glucose closely, especially in patients with diabetes.
■ See Precautions, Drug/Lab Interactions, and Antidote.
A patient medication guide is available from the manufacturer.
■ Discontinue moxifloxacin and promptly report the development of any severe adverse reaction.
■ Review medicines and disease states with physician or pharmacist before initiating therapy.
■ Drink fluids liberally.
■ Inform physician of any history of myasthenia gravis.
■ Patients with a history of myasthenia gravis should avoid use of moxifloxacin.
■ Report skin rash or any other hypersensitivity reaction promptly.
■ Promptly report development of any CNS side effects (e.g., convulsions, dizziness, light-headedness, change in mood or behavior).
■ Inform physician of any history of seizures.
■ Request assistance with ambulation; may cause dizziness and light-headedness. Use caution in tasks that require alertness.
■ Promptly report tendon pain or inflammation, weakness, or inability to use a joint; rest and refrain from exercise.
■ Promptly report burning, numbness, pain, tingling, or weakness in extremities. Nerve damage can be permanent.
■ Promptly report S/S of liver injury (e.g., dark-colored urine, fever, itching, jaundice [yellowing of skin or whites of eyes], light-colored bowel movements, loss of appetite, nausea, right upper quadrant tenderness, tiredness, vomiting, weakness).
■ May produce changes in ECG. Report fainting spells or palpitations promptly.
■ May alter glucose control in diabetic patients on insulin or oral therapy. Monitor glucose carefully. Discontinue moxifloxacin and contact physician if hypoglycemic reaction occurs.
■ Photosensitivity has occurred in patients receiving other quinolones and, infrequently, moxifloxacin. It is best to avoid excessive sunlight or artificial ultraviolet light. May cause severe sunburn; wear protective clothing, use sunscreen, and wear dark glasses outdoors. Report a sunburn-like reaction or skin eruption promptly.
■ Promptly report diarrhea or bloody stools that occur during treatment or up to several months after an antibiotic has been discontinued; may indicate CDAD and require treatment.
■ Seek emergency medical care if sudden chest, stomach, or back pain is experienced.
■ See Precautions, Monitor, Drug/Lab Interactions, and Antidote.
Safety for use in pregnancy not established. Based on animal studies, moxifloxacin may cause fetal harm. Benefit must outweigh risk to fetus.
■ Use caution if breast-feeding infants; consider risk versus benefit.
■ Safety and effectiveness for use in pediatric patients under 18 years of age not established.
■ Quinolones have caused erosion of cartilage in weight-bearing joints and other signs of arthropathy in juvenile animals; however, they have been used in infants and children to treat serious infections unresponsive to other antibiotic regimens.
Safety and effectiveness similar to that of younger adults; however, elderly may experience an increased risk of side effects (e.g., aortic aneurysm and dissection, CNS effects, tendinitis, tendon rupture, risk of QT prolongation).
■ See Precautions.
May cause ventricular arrhythmias or torsades de pointes with drugs that prolong the QT interval, such as Class Ia antiarrhythmic agents (e.g., quinidine, procainamide), Class III antiarrhythmic agents (e.g., amiodarone, sotalol), phenothiazines, tricyclic antidepressants. Use with caution; see Precautions.
■ Risk of CNS stimulation and seizures may be increased with concurrent use of NSAIDs.
■ May cause hyperglycemia and hypoglycemia with concurrent administration of antidiabetic agents; monitoring of blood glucose recommended.
■ May enhance the effects of warfarin; monitoring of PT or INR is recommended with concomitant use.
■ See literature for additional drug/drug interactions on transfer to oral moxifloxacin.
■ May cause a false-positive when testing urine for opiates; more specific testing methods may be indicated.
Diarrhea, dizziness, headache, and nausea were most common and described as mild to moderate in severity. Other side effects reported in 1% or more of patients included abdominal pain, anemia, constipation, dyspepsia, elevated alanine aminotransferase, fever, hypokalemia, insomnia, and vomiting. Capable of numerous other reactions in fewer than 1% of patients. Some of these reactions include cardiovascular effects (e.g., cardiac arrest, palpitations, QT interval prolongation, tachycardia, torsades de pointes, vasodilation, ventricular tachyarrhythmias); CDAD; CNS stimulation (e.g., anxiety, confusion, depression, hallucinations, insomnia, nightmares, paranoia, restlessness, seizures, suicidal thoughts, tremor); hepatic failure; hepatitis and jaundice (predominantly cholestatic); hyperglycemia or hypoglycemia; hypersensitivity reactions (e.g., anaphylaxis, cardiovascular collapse, death, dyspnea, edema [facial, laryngeal, or pharyngeal], hypotension, itching, rash, shock, urticaria); hypotension; increased bilirubin; increased intracranial pressure; pain, inflammation, and ruptures of the shoulder, hand, and Achilles tendon; peripheral neuropathy (e.g., pain, burning, tingling, numbness and/or weakness [see Precautions, Monitor]); photosensitivity/phototoxicity; prolonged PT and INR; Stevens-Johnson syndrome; syncope; and toxic psychoses; see Precautions.
Acute renal insufficiency or failure, allergic pneumonitis; arthralgia; exacerbation of myasthenia gravis; hearing impairment, including deafness (reversible in most); hematologic abnormalities (agranulocytosis, anemia [hemolytic and aplastic], leukopenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura); interstitial nephritis; liver abnormalities (e.g., acute hepatic necrosis or failure, hepatitis, jaundice); muscle weakness; myalgia; peripheral neuropathy; polyneuropathy; rash; serum sickness; severe dermatologic reactions (e.g., toxic epidermal necrolysis [Lyell’s syndrome], Stevens-Johnson syndrome); suicidal ideation/thoughts; vasculitis; vision loss (transient in most cases).
Keep physician informed of all side effects. Most minor side effects will be treated symptomatically or will resolve with continued dosing (e.g., dizziness, light-headedness); monitor closely. Discontinue at first sign of hypersensitivity (e.g., skin rash), CDAD, CNS symptoms, dermatologic reactions, hypoglycemic reactions, phototoxicity, symptoms of peripheral neuropathy, or tendon rupture. Treat hypersensitivity reactions as indicated with epinephrine, airway management, oxygen, IV fluids, antihistamines, corticosteroids, and pressor amines. Treat CNS symptoms as indicated. Mild cases of CDAD may respond to discontinuation of drug. Treat CDAD with fluids, electrolytes, protein supplements, and appropriate antibiotics (e.g., oral vancomycin) as indicated. In severe cases, surgical evaluation may be indicated. Complete rest is indicated for an affected tendon until treatment is available. Discontinue if photosensitivity occurs. Monitoring of the ECG and adequate hydration are indicated in overdose. No specific antidote. Less than 10% of moxifloxacin and its glucuronide metabolite are removed by CAPD or hemodialysis.