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Home » Directories » FDA Approved Drugs » Invanz (ertapenem for injection)

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Invanz (ertapenem for injection)

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Contact: Merck
Website: https://www.merck.com/product/usa/pi_circulars/i/invanz/invanz_pi.pdf

Currently Enrolling Trials

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    General Information

    Invanz is a once-daily injectable penem antibiotic.

    Invanz is approved for use in adults for the treatment of moderate to severe infections caused by common gram-positive and gram-negative aerobic and anaerobic bacteria. Included, are community-acquired pneumonia, intra-abdominal, skin, urinary tract, kidney and post-surgical gynecological infections.

    Prior to administration, Invanz must be reconstituted and diluted.

    Invanz should be infused over 30 minutes in both the Treatment and Prophylactic regimens.

    Dosing considerations should be made in adults with advanced or end stage renal impairment and those on hemodialysis.

    Treatment regimen:

    • Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.
    • Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly.)
    • Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days.

    Prophylaxis regimen for adults:

    • 1 gram single dose given 1 hour prior to elective colorectal surgery.

    Mechanism of Action

    Invanz (ertapenem sodium) is a structurally unique 1-(beta) methyl-carbapenem related to a class of antibiotics known as beta-lactams, which includes penicillins and cephalosporins. Invanz works by blocking the formation of bacterial cell walls, thereby causing cell death.

    Side Effects

    Adverse events associated with the use of Invanz may include (but are not limited to) the following:

    • Diarrhea
    • Infused vein complications
    • Nausea
    • Headache
    • Vaginitis in females

    Clinical Trial Results

    The approval of Invanz is supported by studies conducted in more than 1,900 subjects, in five infectious disease categories. Treatment ranged from three to 14 days. Invanz exhibited an excellent safety profile and showed success rates equivalent to those of comparator antibiotics.

    Approval Date: 2001-11-01
    Company Name: Merck
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