Moxifloxacin Injection

— THERAPEUTIC CATEGORIES —
  • Bacterial infections
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Moxifloxacin Injection Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Moxifloxacin (as HCl) 400mg/250mL; soln for IV infusion; latex- and preservative-free.

    Pharmacological Class

    Quinolone.

    See Also

    How Supplied

    Contact supplier

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Moxifloxacin inhibits topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

    Moxifloxacin Injection Indications

    Indications

    Susceptible infections including acute bacterial sinusitis (ABS), acute bacterial exacerbations of chronic bronchitis (ABECB), community acquired pneumonia, skin and skin structure, complicated intra-abdominal infections, plague. For ABS and ABECB: reserve for those who have no alternative treatment options.

    Moxifloxacin Injection Dosage and Administration

    Adult

    ≥18yrs: 400mg once daily. ABS: treat for 10 days. ABECB: treat for 5 days. Pneumonia: treat for 7–14 days. Skin and skin structure: treat for 7 days, if complicated: 7–21 days. Intra-abdominal: treat for 5–14 days. Plague: treat for 10–14 days; begin as soon as possible after suspected or confirmed exposure. IV formulation may be used if oral route not preferable; administer IV infusion over 60mins, may switch from IV to oral route when clinically indicated.

    Children

    <18yrs: not established.

    Moxifloxacin Injection Contraindications

    Not Applicable

    Moxifloxacin Injection Boxed Warnings

    Boxed Warning

    Serious adverse reactions including tendinitis/tendon rupture, peripheral neuropathy, central nervous system (CNS) effects. Exacerbation of myasthenia gravis.

    Boxed Warning

    Serious adverse reactions including tendinitis/tendon rupture, peripheral neuropathy, central nervous system (CNS) effects. Exacerbation of myasthenia gravis.

    • Fluoroquinolones, including Moxifloxacin Tablets, have been associated with disabling and potentially irreversible serious adverse reactions including tendinitis/tendon rupture, peripheral neuropathy, CNS effects. Discontinue immediately and avoid use if any of these serious reactions occur.

    • Fluoroquinolones, including Moxifloxacin Tablets, may worsen muscle weakness in patients with myasthenia gravis. Avoid use in patients with known history of myasthenia gravis.

    • Due to the risk for serious adverse reactions when using Moxifloxacin Tablets, reserve for use in patients who have no alternative treatment options if treating acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis.

    Moxifloxacin Injection Warnings/Precautions

    Warnings/Precautions

    Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS/psychiatric effects); discontinue immediately if signs/symptoms occur. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. History of myasthenia gravis; avoid. History of QT prolongation, ventricular arrhythmias, proarrhythmic conditions (eg, bradycardia, acute myocardial ischemia), hypokalemia, or hypomagnesemia; avoid. Do not exceed recommended dose or infusion rate; may increase QT prolongation. Increased risk of aortic aneurysm and dissection (esp. in elderly); reserve use only if no alternatives in patients with history or risk of. Hepatic impairment. Monitor ECG in liver cirrhosis. Discontinue at 1st sign of a skin rash, jaundice, or any other hypersensitivity. Monitor blood glucose in diabetic patients; discontinue if hypoglycemia occurs. Maintain adequate hydration. Avoid excessive sun or UV light. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

    • Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture, arthralgia, myalgia, peripheral neuropathy, CNS effects). These reactions can occur within hours to weeks after starting.

    • Discontinue immediately at the first signs or symptoms of any serious adverse reaction. Avoid use of fluoroquinolones in patients who have previously experienced any of these serious adverse reactions with fluoroquinolones.

    Tendinitis and Tendon Rupture

    • Increased risk for tendinitis and tendon rupture in all ages especially in patients >60yrs, in patients taking corticosteroid drugs, or in patients with kidney, heart or lung transplants. Other factors may increase this risk including strenuous physical activity, renal failure, and previous tendon disorders (eg, rheumatoid arthritis).

    • This most frequently involves the Achilles tendon and has also been reported with the rotator cuff, the hand, the biceps, the thumb and other tendons. This can occur bilaterally and within hours or days of starting treatment or several months after completion.

    • Discontinue immediately if pain, swelling, inflammation, or rupture of a tendon develop. Advise patients to rest at the first sign of tendinitis or tendon rupture.

    • Avoid use of fluoroquinolones in patients with a history of tendon disorders or who have experienced tendinitis or tendon rupture.

    Peripheral Neuropathy

    • Increased risk for peripheral neuropathy; these symptoms may occur soon after starting treatment.

    • Discontinue immediately if symptoms of peripheral neuropathy develop; these reactions include pain, burning, tingling, numbness, and/or weakness or other alterations of sensation. Avoid use of fluoroquinolones in patients with a history of peripheral neuropathy.

    Central Nervous System Effects

    • Psychiatric adverse reactions: Increased risk for psychiatric adverse reactions (eg, toxic psychosis, hallucinations or paranoia; depression or suicidal thoughts or acts; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment). Discontinue immediately and treat appropriately if these reactions occur.

    • CNS adverse reactions: Increased risk for seizures, intracranial pressure including pseudotumor cerebri, dizziness, and tremors. Use caution in patients with known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors. Discontinue immediately and treat appropriately if these reactions occur.

    Exacerbation of Myasthenia Gravis

    • May worsen muscle weakness in patients with myasthenia gravis. Avoid use in patients with a history of myasthenia gravis.

    QT Prolongation

    • Avoid in patients with the following risk factors: known or history of QT prolongation, ventricular arrhythmias, proarrhythmic conditions (eg, bradycardia, acute myocardial ischemia), hypokalemia, hypomagnesemia, Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic agents, or other drugs that prolong QT interval (eg, cisapride, erythromycin, antipsychotics, and TCAs).

    • Monitor ECG in patients with liver cirrhosis.

    • Do not exceed the recommended dose or infusion rate.

    Hypersensitivity Reactions, Other Serious and Sometimes Fatal Reactions

    • Discontinue immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures.

    Risk of Aortic Aneurysm and Dissection

    • Increased rate of aortic aneurysm and dissection within 2 months following use especially in elderly patients. In patients at increased risk for aortic aneurysms or those with known aortic aneurysm, reserve use only when no alternative treatments are available.

    Clostridioides difficile-Associated Diarrhea (CDAD)

    • May need to discontinue use if CDAD is suspected or confirmed. Treat appropriately with fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation.

    Arthropathic Effects in Animals

    • Moxifloxacin has caused lameness when administered to immature dogs. Erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals.

    Blood Glucose Disturbances

    • Moxifloxacin may cause disturbances in blood glucose leading to both hypoglycemia and hyperglycemia. Discontinue and treat appropriately if hypoglycemia occurs. Carefully monitor blood glucose for hypoglycemia.

    Photosensitivity/Phototoxicity

    • Avoid excessive exposure to sun or UV light. Discontinue if phototoxicity occurs.

    Pregnancy Considerations

    There are no available human data establishing a drug associated risk with the use of moxifloxacin. Advise pregnant women of the potential risk to the fetus.

    Nursing Mother Considerations

    Unknown if moxifloxacin is present in human milk.

    Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for moxifloxacin tablets and any potential adverse effects on the breastfed child or from the underlying maternal condition.

    Pediatric Considerations

    Effectiveness in pediatric patients and adolescents less than 18 years of age has not been established.

    Geriatric Considerations

    Increased risk for developing severe tendon disorders including tendon rupture. This risk is greater in patients receiving concomitant corticosteroid therapy. Use caution when prescribing moxifloxacin in elderly patients especially those on corticosteroids. Discontinue use if any symptoms of tendinitis or tendon rupture occur.

    Increased risk for QT interval in elderly patients. Avoid use in patients receiving drugs that may cause QT prolongation (eg, class IA or class III antiarrhythmics) or those with risk factors for torsade de pointes.

    Renal Impairment Considerations

    No dosage adjustment is necessary in renally impaired patients including those requiring hemodialysis or continuous ambulatory peritoneal dialysis.

    Hepatic Impairment Considerations

    No dosage adjustment is necessary in hepatically impaired patients. Use caution in these patients due to metabolic disturbances associated with hepatic insufficiency that may lead to QT prolongation.

    Moxifloxacin Injection Pharmacokinetics

    Absorption

    Absolute bioavailability: ~90%. Plasma concentrations increase proportionately with dose up to the highest dose tested.

    Distribution

    Plasma protein bound: ~30–50%. Volume of distribution: 1.7 to 2.7 L/kg.

    Metabolism

    Glucuronide and sulfate conjugation.

    Elimination

    Fecal (~25%), renal (~20%). Half-life: 11.5–15.6hrs (oral); 8.2–15.4 (IV).

    Moxifloxacin Injection Interactions

    Interactions

    Avoid drugs that prolong QTc interval (eg, Class IA or Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, tricyclics). Oral forms: take at least 4hrs before or 8hrs after iron, zinc, magnesium, aluminum, sucralfate, didanosine (buffered forms). Increased risk of tendinitis/tendon rupture with corticosteroids. Concomitant antidiabetics may increase blood glucose disturbances. Increased seizure risk with concomitant NSAIDs. Monitor warfarin.

    Moxifloxacin Injection Adverse Reactions

    Adverse Reactions

    Nausea, diarrhea, dizziness, headache; tendinitis/tendon rupture, peripheral neuropathy, CNS effects, hypersensitivity reactions, phototoxicity (discontinue if occurs), QT prolongation, C. difficile-associated diarrhea, dysglycemia, aortic aneurysm/dissection.

    Moxifloxacin Injection Clinical Trials

    Clinical Trials

    Acute Bacterial Sinusitis

    • A controlled double-blind US study compared moxifloxacin 400mg once daily for 10 days to cefuroxime axetil 250mg twice daily for 10 days for the treatment of 457 patients with acute bacterial sinusitis. Clinical success (cure plus improvement) at the 7 to 21 day post-therapy test of cure visit was 90% for moxifloxacin and 89% for cefuroxime.

    • A noncomparative study evaluated the microbiological eradication in adults who received moxifloxacin 400mg once daily for 7 days. The clinical success rates and eradication/presumed eradication rates at the 21 to 37 day follow-up visit were 97% for Streptococcus pneumoniae, 83% for Moraxella catarrhalis, and 80% for Haemophilus influenzae.

    Acute Bacterial Exacerbation of Chronic Bronchitis

    • A randomized, double-blind, controlled US clinical trial compared moxifloxacin 400mg one daily for 5 days to clarithromycin 500mg twice daily for 10 days for the treatment of acute bacterial exacerbation of chronic bronchitis in 629 patients. The clinical success was 89% for moxifloxacin vs 89% for clarithromycin. The microbiological eradication rates for moxifloxacin were Streptococcus pneumoniae 100%, Haemophilus influenzae 89%, Haemophilus parainfluenzae 100%, Moraxella catarrhalis 85%, Staphylococcus aureus 94%, and Klebsiella pneumoniae 85%.

    Community Acquired Pneumonia

    • A randomized, double-blind, controlled US clinical trial compared moxifloxacin 400mg once daily to clarithromycin 500mg twice daily for the treatment of 474 patients with clinically and radiologically documented community acquired pneumonia. The clinical success at the 14–35 day follow-up visit was 95% for moxifloxacin and 95% for high-dose clarithromycin.

    • A randomized, double-blind, controlled trial conducted in the US and Canada compared sequential IV/oral moxifloxacin 400mg once daily for 7–14 days to an IV/oral fluoroquinolone control (trovafloxacin or levofloxacin) for the treatment of 516 patients with clinically and radiologically documented community acquired pneumonia. The clinical success rate at the 7–30 day post-therapy visit was 86% for moxifloxacin therapy and 89% for the fluoroquinolone comparators.

    • An open-label ex-US study compared moxifloxacin to sequential IV/oral amoxicillin/clavulanate (1.2g IV every 8hrs/625mg orally every 8 hrs) with or without high-dose IV/oral clarithromycin (500mg twice daily). The clinical success rate at Day 5–7 was 93% for moxifloxacin and 85% for amoxicillin/clavulanate ± clarithromycin. The clinical success rate at 21–28 days post-therapy visit was 84% for moxifloxacin and 74% for the comparators.

    Uncomplicated Skin and Skin Structure Infections

    • A randomized, double-blind, controlled US clinical trial compared moxifloxacin 400mg once daily for 7 days to cephalexin 500mg three times daily for 7 days. The clinical success rates were 89% for moxifloxacin and 91% for cephalexin.

    Complicated Skin and Skin Structure Infections (cSSSI)

    • A double-blind trial conducted in North America compared sequential IV/oral moxifloxacin 400mg once daily for 7–14 days to an IV/oral beta-lactam/beta-lactamase inhibitor control for the treatment of 617 patients with cSSSI. A second open-label international study compared moxifloxacin 400mg once daily for 7-21 days to sequential IV/oral beta-lactam/beta-lactamase inhibitor control in the treatment of 804 patients with cSSSI. 

    • In both studies, success rates varied based on the type of diagnosis ranging from 61% for infected ulcers to 90% for complicated erysipelas. These rates were similar to the comparator drugs.

    Complicated Intra-Abdominal Infections

    • A double-blind trial conducted in North America compared sequential IV/oral moxifloxacin 400mg once daily for 5–14 days to IV/piperacillin/tazobactam followed by oral amoxicillin/clavulanic acid in 681 patients with cIAI. The clinical success rate was 79.8% for moxifloxacin and 78.1% for comparator.

    • A second open-label international study compared moxifloxacin 400mg once daily for 5–14 days to IV ceftriaxone plus IV metronidazole followed by oral amoxicillin/clavulanic acid in 595 patients with cIAI. The clinical success rate was 80.9% for moxifloxacin and 82.3% for comparator.

    Plague

    • A randomized, blinded, placebo-controlled study was conducted in an African Green Monkey (AGM) animal model of pneumonic plague. Compared to the placebo group, mortality in the moxifloxacin group was significantly lower (difference in survival: 100% with a two-sided 95% exact confidence interval [66.3%, 100%], P <.0001). The mean plasma concentrations of moxifloxacin associated with a statistically significant improvement in survival over placebo in an AGM model of pneumonic plague are reached or exceeded in human adults receiving the recommended oral and intravenous dosage regimens. 

    Moxifloxacin Injection Note

    Notes

    Formerly known under the brand name Avelox.

    Moxifloxacin Injection Patient Counseling

    Patient Counseling

    Serious Adverse Reactions

    Advise patients to stop taking Moxifloxacin Tablets if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.

    Inform patients of the following serious adverse reactions that have been associated with Moxifloxacin Tablets or other fluoroquinolone use:

    • Disabling and Potentially Irreversible Serious Adverse Reactions: Advise patients of the risk for disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture, arthralgia, myalgia, peripheral neuropathy, CNS effects). Discontinue immediately at the first signs or symptoms of any serious adverse reaction.

    • Tendinitis and Tendon Rupture: Advise patients to contact their healthcare provider if pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints occurs; rest and refrain from exercise; and discontinue moxifloxacin treatment. Increased risk for tendinitis and tendon rupture in all ages especially in patients >60yrs, in patients taking corticosteroid drugs, or in patients with kidney, heart or lung transplants. 

    • Peripheral Neuropathy: Advise patients of the risk for peripheral neuropathies. Discontinue immediately if symptoms of peripheral neuropathy develop; these reactions include pain, burning, tingling, numbness, and/or weakness or other alterations of sensation. 

    • Central Nervous System Effects: Advise patients that convulsions have been reported. Notify your healthcare provider prior to initiating treatment if you have a history of convulsions. Notify your healthcare provider if persistent headache with or without blurred vision occurs.

    • Exacerbation of Myasthenia Gravis: May worsen muscle weakness in patients with myasthenia gravis. Avoid use in patients with a history of myasthenia gravis.

    • Hypersensitivity Reactions, Other Serious and Sometimes Fatal Reactions: Discontinue immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures.

    • Hepatotoxicity: Advise patients that severe hepatoxicity has been reported. Advise patients to inform their healthcare provider if signs or symptoms of livery injury occur.

    • Risk of Aortic Aneurysm and Dissection: Advise patients of the risk for aortic aneurysms or those with known aortic aneurysm, reserve use only when no alternative treatments are available. Seek emergency medical care if sudden chest, stomach or back pain occur.

    • Diarrhea: Contact healthcare provider immediately if watery and bloody stools occur.

    • QT Prolongation: Inform healthcare provider if you have any personal or family history of QT prolongation or proarrhythmic conditions (eg, bradycardia, acute myocardial ischemia), hypokalemia, hypomagnesemia, Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone, sotalol) antiarrhythmic agents, or other drugs that prolong QT interval (eg, cisapride, erythromycin, antipsychotics, and TCAs).

    • Blood Glucose Disturbances: Advise patients that a hypoglycemic reaction may occur. Inform your healthcare provider if you are diabetic and being treated wiht insulin or an oral hypoglycemic agent. Discontinue and treat appropriately if hypoglycemia occurs. 

    • Photosensitivity/Phototoxicity: Minimize or avoid excessive exposure to sun or UV light. Discontinue if phototoxicity occurs.

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