Ampicillin and Sulbactam (Ampicillin Sodium / Sulbactam Sodium) - Summary

SUMMARY

Ampicillin and Sulbactam for Injection, USP

Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin and Sulbactam for Injection and other antibacterial drugs, Ampicillin and Sulbactam for Injection should be used only to treat or prevent 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.

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, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae ), Proteus mirabilis, Bacteroides fragilis , Enterobacter spp., and Acinetobacter calcoaceticus.

NOTE: For information on use in pediatric patients see PRECAUTIONS—Pediatric Use and CLINICAL STUDIES sections.

Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae ), Bacteroides spp. (including B. fragilis), and Enterobacter spp.

Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis ).

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 antibiotic.

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.

See all indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Ampicillin and Sulbactam (Ampicillin / Sulbactam)

Piperacillin/tazobactam plus ceftazidime versus sulbactam/ampicillin plus aztreonam as empirical therapy for fever in severely neutropenic pediatric patients. [2009.04]
CONCLUSIONS: PIPC/TAZ+CAZ and SBT/ABPC+AZT are effective and safe for initial empirical treatment of febrile episodes in neutropenic pediatric patients. The clinical efficacy of SBT/ABPC+AZT is equivalent or superior to that of PIPC/TAZ+CAZ, the effect of which is already proven against febrile neutropenia. Therefore, SBT/ABPC+AZT may be a treatment of choice for febrile neutropenia in pediatric cancer patients.

High-dose ampicillin-sulbactam as an alternative treatment of late-onset VAP from multidrug-resistant Acinetobacter baumannii. [2007]
The increased incidence of multidrug-resistant (MDR) Acinetobacter baumannii ventilator-associated pneumonia in critically ill patients poses a severe therapeutic problem. The aim of this study was to evaluate the efficacy and safety of 2 high-dose treatment regimens of ampicillin-sulbactam (A/S) for MDR Acinetobacter baumannii VAP...

The value of chemoprophylaxis against Enterococcus species in elective cholecystectomy: a randomized study of cefuroxime vs ampicillin-sulbactam. [2006.12]
HYPOTHESIS: Cephalosporins are widely used and considered to be effective as prophylaxis in biliary surgery. Nevertheless, they lack activity against enterococci. We conducted a study to compare the efficacy of ampicillin-sulbactam vs cefuroxime in preventing surgical site infections following elective cholecystectomy... CONCLUSIONS: A single dose of ampicillin-sulbactam favored better compared with cefuroxime for prevention of postoperative surgical site infections due to Enterococcus species after elective cholecystectomy. Ampicillin-sulbactam may be a better agent for antimicrobial prophylaxis in high-risk patients undergoing elective cholecystectomy, especially in a setting where the incidence of enterococcal infections is higher.

Cefepime vs. Ampicillin/Sulbactam and Aztreonam as antibiotic prophylaxis in neurosurgical patients with external ventricular drain: result of a prospective randomized controlled clinical trial. [2006.06]
CONCLUSION: Single board spectrum antibiotic prophylaxis with Cefepime was an effective alternative regimen for neurosurgical patients with an EVD in situ.

[Efficacy and safety of Sultamicillin (Ampicillin/Sulbactan) and Amoxicillin/Clavulanic acid in the treatment of upper respiratory tract infections in adults--an open-label, multicentric, randomized trial] [2006.01]
Upper respiratory tract infections are the most common causes of medical visits in children and adults, demanding massive use of antibiotics. Bacterial resistance caused by beta-lactamase is one of the most serious problems in this matter. Sultamicillin, a double pro-drug of Ampicillin/Sulbactan, is a potent beta-lactamase inhibitor which can face this challenge. AIM: Evaluate efficacy, safety and tolerability of Ampicillin/Sulbactan compared to Amoxicillin/Clavulanate in upper respiratory tract infections in adults... CONCLUSIONS: Ampicillin/Sulbactan is as safe and efficient as Amoxicillin/Clavulanate in the empiric treatment of upper respiratory infections in adults. The low occurrence of diarrhea in the group receiving Ampicillin/Sulbactan needs confirmation in other studies.

more studies >>

Clinical Trials Related to Ampicillin and Sulbactam (Ampicillin / Sulbactam)

Zithromax EV in Community-Acquired Pneumonia (CAP) [Completed]
The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide.

This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.

Study to Proof the Clinical and Bacteriological Non-Inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-Severe Community-Acquired Pneumonia [Recruiting]
The purpose of this study is to proof the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia.

Comparison of Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Intrapartum Chorioamnionitis: a Randomized Controlled Trial [Recruiting]
Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters) surrounding the baby inside of a pregnant woman prior to delivery. This infection is somewhat common and is routinely treated with antibiotics given to the mother both before and after the baby is born. Currently it is not known what is the best choice of antibiotics to treat this type of infection, but commonly used treatments include Unasyn (ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different antibiotic regimens to see if one is better than the other at treating and preventing bad outcomes from chorioamnionitis in women and babies.

Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients [Completed]
To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.

A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections [Recruiting]
On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.

more trials >>