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Ofloxacin

    DEA Class; Rx

    Common Brand Names; Floxin

    • Fluoroquinolones

    Oral, ophthalmic, otic fluoroquinolone anti-infective
    Used for acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections, gonorrhea, NGU, cervicitis, PID, UTIs, and prostatitis
    Associated with disabling and potentially irreversible adverse events, including tendonitis, tendon rupture, and peripheral neuropathy

    Indicated for

    • Bronchitis Exacerbation
    • (Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis)
    • Community Acquired Pneumonia
    • Skin & Skin Structure Infections
    • Acute, Uncomplicated Urethral and Cervical Gonorrhea
    • (No longer recommended for gonorrhea owing to widespread resistance in the US)
    • Nongonococcal Cervicitis/Urethritis or Mixed Infection of Cervix/Urethra
    • Acute Pelvic Inflammatory Disease
    • Uncomplicated Cystitis
    • (Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections)
    • Complicated UTIs
    • Prostatitis Due to E. Coli
    • Traveler’s Diarrhea (Off-label)

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

    • Nausea (3-10%)
    • Headache (1-9%)
    • Insomnia (3-7%)
    • Dizziness (1-5%)
    • Vaginitis (1-5%)
    • Diarrhea (1-4%)
    • Vomiting (1-4%)
    • Appetite decreased (1-3%)
    • Abdominal cramps (1-3%)
    • Abnormal taste (1-3%)
    • Chest pain (1-3%)
    • External genital pruritis in women (1-3%)
    • Fatigue (1-3%)
    • Flatulence (1-3%)
    • GI distress (1-3%)
    • Nervousness (1-3%)
    • Pharyngitis (1-3%)
    • Pyrexia (1-3%)
    • Rash/pruritis (1-3%)
    • Sleep disorders (1-3%)
    • Visual disturbances (1-3%)
    • Xerostomia (1-3%)

    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

    Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay symptoms of incubating syphilis; all patients with gonorrhea should have a serologic test for syphilis at time of diagnosis; patients treated for gonorrhea should have a follow-up serologic test for syphilis after three months and, if positive, treatment with an appropriate antimicrobial should be instituted

    Administer ofloxacin with caution in presence of renal or hepatic insufficiency/impairment; in patients with known or suspected renal or hepatic insufficiency/impairment, perform careful clinical observation and appropriate laboratory studies prior to and during therapy; elimination of ofloxacin may be reduced; alteration of the dosage regimen is necessary in patients with impaired renal function (creatinine clearance <50 mg/mL)

    Excessive exposure UV light or sun should be avoided; discontinue therapy if photosensitivity/phototoxicity occurs

    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

    Pregnancy Category: C

    Lactation: excreted in breast milk, discontinue drug or do not nurse

    Adults

    800 mg/day PO. For ophthalmic and otic dosages, see indications.

    Geriatric

    800 mg/day PO. For ophthalmic and otic dosages, see indications.

    Adolescents

    Safety and efficacy have not been established; however, doses up to 30 mg/kg/day (Max: 800 mg/day) PO have been used off-label. For ophthalmic and otic dosages, see indications.

    Children

    Safety and efficacy have not been established; however, doses up to 30 mg/kg/day (Max: 800 mg/day) PO have been used off-label. For ophthalmic and otic dosages, see indications.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Ofloxacin 

    tablet

    • 200mg
    • 300mg
    • 400mg

    otic solution

    • 0.3%

    ophthalmic solution

    • 0.3%