Label: AMPICILLIN AND SULBACTAM injection, powder, for solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 1, 2025

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  • SPL UNCLASSIFIED SECTION
    PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION - AVENACY - Rx only - To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin and Sulbactam for ...
  • DESCRIPTION
    Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam ...
  • CLINICAL PHARMACOLOGY
    General - Immediately after completion of a 15-minute intravenous infusion of ampicillin and sulbactam for injection, peak serum concentrations of ampicillin and sulbactam are attained ...
  • MICROBIOLOGY
    Ampicillin is similar to benzyl penicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of cell wall ...
  • INDICATIONS AND USAGE
    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 ...
  • CONTRAINDICATIONS
    The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ...
  • WARNINGS
    Hypersensitivity - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in ...
  • PRECAUTIONS
    General - A high percentage of patients with mononucleosis who receive ampicillin develop a skin rash. Thus, ampicillin class antibacterials should not be administered to patients with ...
  • ADVERSE REACTIONS
    Adult Patients - Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported in clinical trials. Local Adverse Reactions - Pain at IM ...
  • OVERDOSAGE
    Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular ...
  • CLINICAL STUDIES
    Skin and Skin Structure Infections in Pediatric Patients - Data from a controlled clinical trial conducted in pediatric patients provided evidence supporting the safety and efficacy of ...
  • DOSAGE AND ADMINISTRATION
    The pharmacy bulk package is for preparation of solutions for IV infusion only. Ampicillin and sulbactam for injection should be administered by slow intravenous injection over at least 10 to 15 ...
  • COMPATIBILITY, RECONSTITUTION AND STABILITY
    When concomitant therapy with aminoglycosides is indicated, ampicillin and sulbactam for injection and aminoglycosides should be reconstituted and administered separately, due to the in vitro ...
  • DIRECTIONS FOR USE
    Intravenous Administration - Directions for Proper Use of Pharmacy Bulk Package - Ampicillin and sulbactam for injection sterile powder for intravenous use may be reconstituted with any of the ...
  • HOW SUPPLIED
    Ampicillin and Sulbactam for Injection, USP (ampicillin sodium/sulbactam sodium) is a sterile powder supplied in a Pharmacy Bulk Package as follows: NDCAmpicillin and Sulbactam for ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – Bottle Label - NDC 83634-108-99 - Ampicillin and Sulbactam for Injection, USP - 15 grams per Pharmacy Bulk Package - PHARMACY BULK PACKAGE - NOT FOR DIRECT ...
  • INGREDIENTS AND APPEARANCE
    Product Information