moxifloxacin (Rx)

Brand and Other Names:Avelox, Moxifloxacin Systemic
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 400mg/250mL

tablet

  • 400mg
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Acute Bacterial Sinusitis

400 mg PO/IV qDay for 5-10 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis

Community-Acquired Pneumonia

400 mg PO/IV qDay for 7-14 days

Acute Exacerbation of Chronic Bronchitis

Indicated for acute exacerbations of chronic bronchitis caused by bacterial infections

400 mg PO/IV qDay for 5 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Skin & Skin Structure Infections

Uncomplicated: 400 mg PO/IV qDay for 7 days

Complicated: 400 mg PO/IV qDay for 7-21 days

Intra-abdominal Infections

Complicated: 400 mg PO/IV qDay for 5-14 days

Pneumonic & Septicemic Plague

Indicated in adults for the treatment of plague, including pneumonic and septicemic plague, caused by susceptible isolates of Yersinia pestis; it is also indicated for prophylaxis of plague in adults

400 mg PO/IV qDay x10-14 days

Begin administration as soon as possible after suspected or confirmed exposure to Yersinia pestis

Dosing Considerations

Initial IV administration may be changed to PO administration at same dosage to complete therapy, depending on patient's clinical status

Susceptible organisms

  • Aeromonas hydrophila, Bacillus anthracis, Bacteroides fragilis, Bacteroides thetaiotaomicron, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Clostridium perfringens, Escherichia coli, Enterobacter spp, Haemophilus influenzae, Hafnia alvei, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, Mycobacterium pneumoniae, Mycobacterium tuberculosis, Neisseria gonorrhoeae, Peptostreptococcus spp, Proteus mirabilis, Proteus vulgaris, Providencia spp, Pseudomonas aeruginosa, Salmonella typhi, Shigella spp, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus anginosus, Streptococcus constellatus, Streptococcus pneumoniae, Vibrio cholerae, Yersinia pestis
  • First-line therapy: C jejuni; no unanimity on others (eg, L pneumophila, M morganii)

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and moxifloxacin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Nausea (7%)

            Diarrhea (6%)

            Dizziness (3%)

            Decreased amylase (2%)

            Decreased basophils, eosinophils, hemoglobin, prothrombin time, red blood cells, neutrophils (2%)

            Decreased serum glucose (2%)

            Increased serum chloride (2%)

            Increased serum ionized calcium (2%)

            Immune hypersensitivity reaction (0.1-2%)

            Prolonged QT interval (0.1-2%)

            <1%

            Acute renal failure

            Agranulocytosis

            Anaphylactoid reaction

            Aplastic anemia

            Extrinsic allergic alveolitis

            Hemolytic anemia

            Hepatic failure

            Hepatic necrosis

            Hepatitis

            Pancytopenia

            Seizure

            Serum sickness due to drug

            Stevens-Johnson syndrome

            Tendon rupture, tendinitis

            Thrombocytopenia

            Torsades de pointes

            Toxic epidermal necrolysis

            Postmarketing Reports

            Blood and lymphatic disorders: Agranulocytosis, pancytopenia

            Cardiovascular disorders: Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes)

            Ear and labyrinth disorders: Hearing impairment, including deafness (reversible in most cases)

            Eye disorders: Vision loss (especially in the course of CNS reactions, transient in majority of cases)

            Hepatobiliary disorders: Hepatitis, hepatic failure, jaundice, acute hepatic necrosis

            Immune system disorders: Anaphylactic reactions including shock, angioedema (including laryngeal edema)

            Musculoskeletal/connective tissue disorders: Tendon rupture, arthralgia, myalgia

            Nervous system disorders: Exacerbation of myasthenia gravis symptoms, altered coordination, abnormal gait, muscle weakness, peripheral neuropathy, polyneuropathy

            Central nervous system effects: Hallucinations, anxiety, depression, insomnia, severe headaches, and confusion

            Psychiatric disorders: Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts)

            Renal and urinary disorders: Renal dysfunction, interstitial nephritis

            Respiratory disorders: Allergic pneumonitis

            Skin and tissue disorders: Photosensitivity/phototoxicity reaction, Stevens-Johnson syndrome, Toxic epidermal necrolysis

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            Warnings

            Black Box Warnings

            Serious adverse effects

            • 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 the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions
            • May exacerbate muscle weakness in patients with myasthenia gravis; fluoroquinolones should be avoided in patients with known history of myasthenia gravis
            • Because fluoroquinolones have been associated with serious adverse reactions, reserve drug use in patients who have no alternative treatment options for the following indications: Acute bacterial sinusitis; acute bacterial exacerbation of chronic bronchitis

            Contraindications

            Hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials

            Cautions

            Fluoroquinolones been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient; adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); discontinue treatment immediately at the first signs or symptoms of any serious adverse reaction; avoid use in patients who have experienced any of these serious adverse reactions

            Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages; adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons (see Black Box Warnings)

            In prolonged therapy, perform periodic evaluations of organ system function (eg, renal, hepatic, hematopoietic); superinfections may occur with prolonged or repeated antibiotic therapy

            Phototoxicity reactions may occur; avoid excessive sunlight

            Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent

            Serious, sometimes fatal hypoglycemia reported including in patients without a history of hypoglycemia (common with gatifloxacin, which is no longer marketed); monitor glucose levels closely in patients with diabetes; if hypoglycemic reaction occurs, discontinue therapy and initiate appropriate therapy immediately

            Avoid use in presence of drugs or conditions that prolong QT interval, patients with known prolongation of the QT interval, patients with ventricular arrhythmias including torsade de pointes because QT prolongation may lead to an increased risk for these conditions, patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia and acute myocardial ischemia or patients with hypokalemia or hypomagnesemia

            In immature dogs, oral administration of moxifloxacin caused lameness; related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species

            Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190

            Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

            Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

            Serious anaphylactic reactions reported in patients receiving fluoroquinolone therapy; discontinue treatment at the first appearance of a skin rash or any other sign of hypersensitivity

            Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported; reactions may be severe and generally occur following the administration of multiple doses; discontinue treatment immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and institute supportive measures

            CNS effects

            • Fluoroquinolones have been associated with an increased risk of CNS effects, including: convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis
            • May also cause CNS events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care
            • Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)

            FDA MedWatch Safety Alert

            • Issued July 10, 2018
            • The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects
            • Hypoglycemia, sometimes resulting in coma, occurred more frequently in elderly patients or in diabetic patients taking oral hypoglycemic medicine or insulin
            • Alert patients regarding hypoglycemic symptoms and carefully monitor blood glucose levels; instruct patients how to treat themselves if symptoms of hypoglycemia occur
            • This safety alert affects only systemic formulations; early signs and symptoms of low blood glucose include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, and/or unusual anxiety
            • Mental health side effects are to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium
            • Inform patients of the potential risk of psychiatric adverse reactions that can occur after just 1 dose
            • Immediately discontinue treatment if CNS adverse effects occur, including psychiatric adverse reactions, or blood glucose disturbances occur and switch to a nonfluoroquinolone antibiotic if possible
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            Pregnancy & Lactation

            Pregnancy

            There are no available human data establishing a drug associated risk; however, when moxifloxacin was administered to rats during pregnancy and throughout lactation at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed

            Advise pregnant women of potential risk to fetus

            Lactation

            Not known if moxifloxacin is present in human milk

            Based on animal studies in rats, moxifloxacin may be excreted in human milk

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from drug or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits A subunits of DNA gyrase, resulting in inhibition of bacterial DNA replication and transcription

            Absorption

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

            Bioavailability: 90%

            Distribution

            Protein bound: 50%

            Vd: 1.7-2.7 L/kg; tissue concentrations often exceed plasma concentrations in respiratory tissues, alveolar macrophages, and sinus tissues

            Metabolism

            Metabolized in liver via glucuronide (14%) and sulfate (38%) conjugation

            Elimination

            Half-life: PO, 12 hr; IV, 15 hr

            Excretion: Feces (25%), urine (20% as unchanged drug)

            Sulfate conjugate metabolites are excreted in feces, glucuronide conjugate metabolites in urine

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            Administration

            IV Preparation

            No further dilution of infusion solution is necessary

            IV Administration

            Infuse over 1 hour

            Do not admix with other drugs or infuse through same tubing simultaneously

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.