RiteMED Cefuroxime Axetil

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RiteMED Cefuroxime Axetil

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QUANTITY:

FDA Approved

FDA

Approved

Pharmacist Reviewed

Pharmacist

Reviewed

FORMULATION

Each film-coated tablet contains:

Cefuroxime (as axetil) ......................................................... 250 mg or 500 mg

PRODUCT DESCRIPTION

RiteMED® Cefuroxime 250 mg and 500 mg Tablet:

White to off-white colored, capsule-shaped tablet with breakline on one side.

  • INDICATIONS

    For the treatment of the following infections caused by susceptible microorganisms:

    • Upper respiratory tract infections including:
    • Acute sinusitis
    • Acute otitis media
    • Acute tonsillopharyngitis
    • Lower respiratory tract infections including:
    • Acute bacterial exacerbations of chronic bronchitis
    • Secondary bacterial infections of acute bronchitis
    • Uncomplicated skin and skin structure infections including furunculocis, pyoderma and impetigo
    • Uncomplicated urinary tract infections including pyelonephritis
    • Uncomplicated gonorrhea
    • Early Lyme disease (erythema migrans)
    • Step down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral cefuroxime

    DOSAGE AND ADMINISTRATION

    In general, most infections in adults and adolescents (13 years and older) will respond to 250 mg every 12 hours. However, for more severe infections, 500 mg every 12 hours may be recommended.

    Recommended Dose

    (To be taken orally after meals)

    Acute sinusitis

    Children (7–12 years old who can swallow tablets whole): 250 mg every 12 hours
    Adults and adolescents (13 years and older): 250 mg or 500 mg every 12 hours
    Duration: 10 days

    Acute otitis media

    Children: 250 mg every 12 hours
    Adults and adolescents: 500 mg every 12 hours
    Duration: 10 days

    Acute tonsillopharyngitis

    Children: 250 mg every 12 hours
    Adults and adolescents: 250 mg or 500 mg every 12 hours
    Duration: 10 days

    Acute bacterial exacerbations of chronic bronchitis

    Children: 250 mg every 12 hours
    Adults and adolescents: 250 mg or 500 mg every 12 hours
    Duration: 10 days*

    Secondary bacterial infections of acute bronchitis

    Children: 250 mg every 12 hours
    Adults and adolescents: 250 mg or 500 mg every 12 hours
    Duration: 5–10 days

    Uncomplicated skin and skin structure infections

    Children: 250 mg every 12 hours
    Adults and adolescents: 250 mg or 500 mg every 12 hours
    Duration: 10 days

    Uncomplicated urinary tract infections, including pyelonephritis

    Children: 250 mg every 12 hours
    Adults and adolescents: 250 mg or 500 mg every 12 hours
    Duration: 7–10 days

    Uncomplicated gonorrhea

    Adults and adolescents: 1,000 mg as a single dose

    Early Lyme disease

    Children: 250 mg every 12 hours
    Adults and adolescents: 500 mg every 12 hours, or as prescribed by a physician
    Duration: 20 days

    *The safety and effectiveness of cefuroxime axetil administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established.