Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. If an allergic reaction occurs (itching, urticaria, dyspnea or facial edema, loss of consciousness, tingling, cardiovascular collapse) discontinue drug immediately. Prolonged use may result in superinfection; pseudomembranous colitis may occur and should be considered in all patients who present with diarrhea. Quinolones may exacerbate myasthenia gravis, use with caution (rare, potentially life-threatening weakness of respiratory muscles may occur). Peripheral neuropathy may rarely occur.

Ophthalmic: Eye drops should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Contact lenses should not be worn during therapy.

Systemic:

3% to 10%:

Central nervous system: Dizziness (3%)

Gastrointestinal: Nausea (7%), diarrhea (6%)

0.1% to 3%:

Cardiovascular: Chest pain, hypertension, palpitation, peripheral edema, QT prolongation, tachycardia

Central nervous system: Anxiety, chills, confusion, headache, insomnia, nervousness, pain, somnolence, tremor, vertigo

Dermatologic: Dry skin, pruritus, rash (maculopapular, purpuric, pustular)

Endocrine & metabolic: Serum chloride increased (2%), serum ionized calcium increased (2%), serum glucose decreased (2%)

Gastrointestinal: Abdominal pain, amylase increased, amylase decreased (2%), anorexia, constipation, dry mouth, dyspepsia, flatulence, glossitis, lactic dehydrogenase increased, stomatitis, taste perversion, vomiting

Hematologic: Eosinophilia, leukopenia, prothrombin time prolonged, increased INR, thrombocythemia, thrombocytopenia

Increased serum levels of the following (2%): MCH, neutrophils, WBC

Decreased serum levels of the following (2%): Basophils, eosinophils, hemoglobin, RBC, neutrophils

Hepatic: Bilirubin decreased (2%), cholestatic jaundice, GGTP increased, liver function test abnormal

Local: Injection site reaction

Neuromuscular & skeletal: Arthralgia, back pain, leg pain, myalgia, paresthesia, malaise, weakness

Renal: Serum albumin increased (2%)

Respiratory: Dyspnea, pharyngitis, pneumonia, rhinitis, sinusitis, PO2 increased (2%)

Miscellaneous: Allergic reaction, infection, moniliasis, diaphoresis

<0.1%, postmarketing, and/or case reports: Abnormal dreams, agitation, amblyopia, amnesia, anaphylactic reaction, anaphylactic shock, anemia, angioedema, aphasia, arthritis, asthma, atrial fibrillation, C. difficile-positive diarrhea, cholestasis, convulsions, depersonalization, depression, dysphagia, ECG abnormalities, emotional lability, face edema, gastritis, hallucinations, hepatitis, hyperglycemia, hyperlipidemia, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (cholestatic), kidney function abnormalities, laryngeal edema, parosmia, pelvic pain, peripheral neuropathy, prothrombin time increased, pseudomembranous colitis, psychotic reaction, sleep disorder, speech disorder, Stevens-Johnson syndrome, supraventricular tachycardia, taste loss, tendon rupture, thinking abnormal, thromboplastin decreased, tinnitus, tongue discoloration, urticaria, ventricular tachycardia, vision abnormalities. Torsade de pointes and cardiac arrest have been reported (very rarely), usually in patients with concurrent, severe proarrhythmic conditions.

Additional reactions with ophthalmic preparation: 1% to 6%: Conjunctivitis, dry eye, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, tearing, visual acuity decreased

Corticosteroids: Concurrent use may increase the risk of tendon rupture, particularly in elderly patients (overall incidence rare).

Glyburide: Quinolones may increase the effect of glyburide; monitor

Metal cations (aluminum, calcium, iron, magnesium, and zinc) bind quinolones in the gastrointestinal tract and inhibit absorption. Concurrent administration of most antacids, oral electrolyte supplements, quinapril, sucralfate, and some didanosine formulations (chewable/buffered tablets and pediatric powder for oral suspension) should be avoided. Moxifloxacin should be administered 4 hours before or 8 hours after these agents. Calcium products do not appear to significantly affect moxifloxacin absorption.

QTc-prolonging agents: Effects may be additive with moxifloxacin. Avoid concurrent use with Class Ia and Class III antiarrhythmics, erythromycin, cisapride, antipsychotics, and cyclic antidepressants.

Warfarin: The hypoprothrombinemic effect of warfarin may be enhanced by some quinolone antibiotics; monitor INR.

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, and sinus tissues

Protein binding: 50%

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

Bioavailability: 90%

Half-life elimination: Oral: 12 hours; I.V.: 15 hours

Excretion: Approximately 45% of a dose is excreted in feces (25%) and urine (20%) as unchanged drug

Metabolites: Sulfate conjugates in feces, glucuronide conjugates in urine

Oral, I.V.: Adults:

Acute bacterial sinusitis: 400 mg every 24 hours for 10 days

Chronic bronchitis, acute bacterial exacerbation: 400 mg every 24 hours for 5 days

Note: Avelox® ABC Pack™ (Avelox® Bronchitis Course) contains five tablets of 400 mg each.

Community-acquired pneumonia (including MDRSP): 400 mg every 24 hours for 7-14 days

Uncomplicated skin infections: 400 mg every 24 hours for 7 days

Elderly: No dosage adjustments are required based on age

Dosage adjustment in renal impairment: No dosage adjustment is required, including patients on hemodialysis or CAPD

Dosage adjustment in hepatic impairment: No dosage adjustment is required in mild to moderate hepatic insufficiency (Child-Pugh Class A and B). Not recommended in patients with severe hepatic insufficiency.

Ophthalmic: Children 1 year and Adults: Instill 1 drop into affected eye(s) 3 times/day for 7 days

I.V.: Report any redness, swelling, or pain at infusion site; any swelling of mouth, lips, tongue, or throat; chest pain or tightness; respiratory difficulty; back pain; itching; skin rash; tingling; tendon pain; dizziness; abnormal thinking; or anxiety.

Oral: Take exactly as directed with or without food. Do not take antacids 4 hours before or 8 hours after taking this medication. Do not miss a dose (take a missed dose as soon as possible, unless it is almost time for your next dose). Take entire prescription even if feeling better. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause nausea, vomiting, taste perversion (small, frequent meals, good mouth care, chewing gum, or sucking hard candy may help); headache, dizziness, insomnia, anxiety (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report immediately any swelling of mouth, lips, tongue or throat; chest pain or tightness; respiratory difficulty; back pain; itching; skin rash; tingling; tendon pain; pain or numbness (loss of sensation) in extremities; confusion, dizziness, abnormal thinking, or anxiety; or insomnia. Report changes in voiding pattern; vaginal itching, burning, or discharge; vision changes or hearing; abnormal bruising or bleeding or blood in urine; or other adverse reactions.

Ophthalmic: Wash hands before instilling solution. Sit or lie down to instill. Open eye, look at ceiling, and instill prescribed amount of solution as directed. Do not touch tip of applicator or let tip of applicator touch eye. Do not wear contact lenses during therapy. Temporary stinging or blurred vision, or dry eyes may occur. Report persistent pain, burning, excessive tearing, decreased visual acuity, swelling, itching, or worsening of condition.

Infusion [premixed in sodium chloride 0.8%] (Avelox® I.V.): 400 mg (250 mL)

Solution, ophthalmic (Vigamox™): 0.5% (3 mL)

Tablet [film coated]:

Avelox®: 400 mg

Avelox® ABC Pack [unit-dose pack]: 400 mg (5s)

Balfour JA and Wiseman LR, "Moxifloxacin,"Drugs, 1999, 57(3):363-73.

Blondeau JM, "Expanded Activity and Utility of the New Fluoroquinolones: A Review,"Clinical Therapeutics, 1999, 21(1):3-40.

"Gatifloxacin and Moxifloxacin: Two New Fluoroquinolones,"The Medical Letter, 2000, Vol 42, 1072:15.