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Moxifloxacin

    DEA Class; Rx

    Common Brand Names; Avelox, Moxifloxacin Systemic, Vigamox, Moxeza

    • Fluoroquinolones, 

    Ophthalmic, oral, and intravenous fluoroquinolone anti-infective
    Used for acute exacerbation of chronic bronchitis, acute sinusitis, bacterial conjunctivitis, community-acquired pneumonia, intra-abdominal infections, skin and skin structure infections, and plague
    Associated with disabling and potentially irreversible adverse events, including tendonitis, tendon rupture, and peripheral neuropathy

    Indicated for

    • Acute Bacterial Sinusitis
    • Community-Acquired Pneumonia
    • Skin & Skin Structure Infections
    • Intra-abdominal Infections

    Indicated for acute exacerbations of chronic bronchitis caused by bacterial infections.

    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

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

    • 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%)
    • 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

    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

    There are no available human data establishing a drug associated risk;

    Not known if moxifloxacin is present in human milk

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

    Adults

    3 drops/eye/day for Vigamox and 2 drops/eye/day for Moxeza; 400 mg/day PO/IV is the FDA-approved maximum dosage, 800 mg/day PO/IV has been used off-label.

    Geriatric

    3 drops/eye/day for Vigamox and 2 drops/eye/day for Moxeza; 400 mg/day PO/IV is the FDA-approved maximum dosage, 800 mg/day PO/IV has been used off-label.

    Adolescents

    3 drops/eye/day for Vigamox and 2 drops/eye/day for Moxeza. Safety and efficacy of oral and injectable formulations have not been established; however, 15 mg/kg/day PO/IV has been used off-label.

    Children

    3 drops/eye/day for Vigamox and 2 drops/eye/day for Moxeza. Safety and efficacy of oral and injectable formulations have not been established; however, 15 mg/kg/day PO/IV has been used off-label.

    Infants

    4 to 11 months: 3 drops/eye/day for Vigamox and 2 drops/eye/day for Moxeza. Safety and efficacy of oral and injectable formulations have not been established; however, 15 mg/kg/day PO/IV has been used off-label.
    1 to 3 months: 3 drops/eye/day for Vigamox; safety and efficacy of Moxeza has not been established. Safety and efficacy of oral and injectable formulations have not been established; however, 15 mg/kg/day PO/IV has been used off-label.

    Neonates

    3 drops/eye/day for Vigamox; safety and efficacy of all other formulations have not been established.

    Moxifloxacin

    injectable solution

    • 400mg/250mL

    tablet

    • 400mg

    ophthalmic solution

    • 0.5%