Generic Name

Sulbactam

Brand Names
Xacduro, Unasyn
FDA approval date: November 22, 1991
Classification: beta Lactamase Inhibitor
Form: Injection, Kit

What is Xacduro (Sulbactam)?

Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* , Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.* NOTE: For information on use in pediatric patients. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. , Bacteroides spp. , and Enterobacter spp.* Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* . * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Brand Information

    Xacduro (sulbactam and durlobactam)
    1DOSAGE FORMS AND STRENGTHS
    XACDURO is a co-packaged kit containing the following two components as sterile powders for reconstitution:
    • 1 clear single-dose vial of sulbactam for injection 1g (as white to off-white powder) and
    • 2 amber single-dose vials of durlobactam for injection 0.5g (as solid cake or powder) in each vial.
    2CONTRAINDICATIONS
    XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs
    3ADVERSE REACTIONS
    The following serious adverse reactions are described in greater detail in the Warnings and Precautions section:
    • Hypersensitivity Reactions
    • Clostridioides difficile-Associated Diarrhea (CDAD) [see
    3.1Clinical Trials Experience
    Clinical trials are conducted under widely varying conditions, therefore adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    The safety of durlobactam with or without sulbactam was evaluated in 380 adult subjects across six phase 1 trials, one phase 2 trial in patients with complicated urinary tract infections (cUTIs) including acute pyelonephritis, and one phase 3 trial (also referred to as Trial 1) in adult patients with infections caused by
    In the randomized, active-controlled portion of the phase 3 trial, 91 patients received XACDURO (1 g sulbactam and 1 g durlobactam, or renally adjusted dose) intravenously over 3 hours every 6 hours and 86 patients were treated with colistin 2.5 mg/kg (or renally adjusted dose) intravenously over 30 minutes every 12 hours after an initial loading dose of colistin 2.5 to 5 mg/kg. Both treatment arms also received 1 g imipenem/1 g cilastatin (or renally adjusted dose) intravenously every 6 hours as background therapy for potential HABP/VABP pathogens other than
    4OVERDOSAGE
    There is no information on the clinical signs and symptoms associated with an overdose of XACDURO. Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Sulbactam and durlobactam are removed by hemodialysis
    5DESCRIPTION
    XACDURO (sulbactam for injection and durlobactam for injection) is an antibacterial co-packaged product containing sulbactam sodium, a penicillin derivative beta-lactam antibacterial and beta-lactamase inhibitor, and durlobactam sodium, a diazabicyclooctane beta-lactamase inhibitor, for intravenous administration.
    6INSTRUCTIONS FOR USE
    Important Information
    For product complaints or questions, please call 1-800-651-3861.
    1 Prepare Supplies
    2 Clean Supplies
    XACDURO
    © 2023 Entasis Therapeutics. All rights reserved.
    INS16343 01 Approved 2023 MAY
    7PRINCIPAL DISPLAY PANEL - Kit Carton
    Sterile
    XACDURO
    Durlobactam must be
    Single-dose kit – 1 g/1 g per kit
    Each carton contains:
    ENTASIS
    Recommended dosage:
    PRINCIPAL DISPLAY PANEL - Kit Carton
    8PRINCIPAL DISPLAY PANEL - 0.5 g Vial Label - 1 of 3
    NDC 68547-311-30
    For intravenous infusion after dilution
    Durlobactam 0.5 g/vial
    Vial
    Must be administered
    For use as part of XACDURO
    Recommended dosage:
    Single-Dose Vial - Discard Unused Portion
    Store in refrigerator at 2° C to 8° C (36° F to 46° F).
    Principal Display Panel - 0.5 g Vial Label - 1 of 3
    9PRINCIPAL DISPLAY PANEL - 0.5 g Vial Label - 2 of 3
    NDC 68547-311-30
    For intravenous infusion after dilution
    Durlobactam 0.5 g/vial
    Vial
    Must be administered
    For use as part of XACDURO
    Recommended dosage:
    Single-Dose Vial - Discard Unused Portion
    Store in refrigerator at 2° C to 8° C (36° F to 46° F).
    Principal Display Panel - 0.5 g Vial Label - 2 of 3
    10PRINCIPAL DISPLAY PANEL - 1 g Vial Label
    NDC 68547-211-20
    For intravenous infusion after dilution
    Sulbactam 1 g/vial
    Vial
    Must be administered
    For use as part of XACDURO
    Recommended dosage:
    Single-Dose Vial - Discard Unused Portion
    Store in refrigerator at 2° C to 8° C (36° F to 46° F).
    Principal Display Panel - 1 g Vial Label
    Xacduro has been selected.