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Levofloxacin

    Brands

    DEA Class; Rx

    Common Brand Names; Levaquin, Levofloxacin Systemic

    • Fluoroquinolones, 
    • Quinolones, Ophthalmic

    Oral, ophthalmic, and IV quinolone antibiotic
    Used for bacterial conjunctivitis, sinusitis, chronic bronchitis, pneumonia, skin and skin structure infections, UTIs, prostatitis, inhalation anthrax, and plague
    Associated with disabling and potentially irreversible adverse reactions, including tendonitis, tendon rupture, peripheral neuropathy, and central nervous system effects

    Indicated for

    • Community-Acquired Pneumonia
    • Nosocomial Pneumonia
    • Acute Bacterial Sinusitis (Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis)
    • Acute Bacterial Exacerbation of Chronic Bronchitis
    • (Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis)
    • Inhalational Anthrax
    • Skin/Skin Structure Infections
    • Chronic Bacterial Prostatitis
    • Complicated Urinary Tract Infections & Acute Pyelonephritis
    • Uncomplicated Urinary Tract Infections (Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections)

    Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older

    Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis

    Documented hypersensitivity

    • Nausea (7%)
    • Headache (6%)
    • Diarrhea (5%)
    • Insomnia (4%)
    • Constipation (3%)
    • Dizziness (3%)
    • Dyspepsia (2%)
    • Rash (2%)
    • Vomiting (2%)
    • Chest pain (1%)
    • Dyspnea (1%)
    • Edema (1%)
    • Fatigue (1%)
    • Injection-site reaction (1%)
    • Moniliasis (1%)
    • Pain (1%)
    • Pruritus (1%)
    • Vaginitis (1%)

    Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose

    Use caution in hematologic and renal toxicities

    Hepatotoxicity reported with therapy

    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

    Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); these reactions can occur within hours to weeks after starting therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones

    Risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants; other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis

    Levofloxacin has not been shown to increase risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

    Drug is present in human milk following intravenous and oral administration; there is no information regarding effects on milk production or breastfed infant; because of potential risks of serious adverse reactions, in breastfed infants, a lactating woman may consider pumping and discarding breast milk during treatment and an additional two days (five half-lives) after last dose

    Adults

    750 mg/day PO/IV; 1,250 mg/day PO/IV has been used off-label.

    Geriatric

    750 mg/day PO/IV; 1,250 mg/day PO/IV has been used off-label.

    Adolescents

    weight 50 kg or more: 500 mg/day PO/IV is FDA-approved; however, doses up to 20 mg/kg/day PO/IV (Usual Max: 1,000 mg/day) have been used off-label.
    weight less than 50 kg: 16 mg/kg/day PO/IV (Max: 500 mg/day or 250 mg/dose) is FDA-approved; however, doses up to 20 mg/kg/day PO/IV (Usual Max: 1,000 mg/day) have been used off-label.

    Children

    weight 50 kg or more: 500 mg/day PO/IV is FDA-approved; however, doses up to 20 mg/kg/day PO/IV (Max: 1,000 mg/day) have been used off-label.
    weight less than 50 kg: 16 mg/kg/day PO/IV (Max: 500 mg/day or 250 mg/dose) is FDA-approved; however, doses up to 20 mg/kg/day PO/IV (Max: 1,000 mg/day) have been used off-label.

    Infants

    6 to 11 months: 16 mg/kg/day PO/IV is FDA-approved; however, doses up to 20 mg/kg/day PO/IV have been used off-label.
    1 to 5 months: Safety and efficacy have not been established; however, doses up to 20 mg/kg/day PO/IV have been used off-label.

    Neonates

    Safety and efficacy have not been established.

    Levofloxacin

    premix, ready-to-use injection

    • 250mg/50mL
    • 500mg/100mL
    • 750mg/150mL

    oral solution

    • 25mg/mL

    tablet

    • 250mg
    • 500mg
    • 750mg

    ophthalmic solution

    • 0.5%