Unasyn (Ampicillin Sodium / Sulbactam Sodium) - Summary

UNASYN SUMMARY

UNASYN®
(ampicillin sodium/sulbactam sodium)

UNASYN is an injectable antibacterial combination consisting of the semisynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration.

UNASYN 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. ^* (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 ^* ).

* Efficacy for this organism in this organ system was studied in fewer than 10 infections.

While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN 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 UNASYN.

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 UNASYN and other antibacterial drugs, UNASYN 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.

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NEWS HIGHLIGHTS

Published Studies Related to Unasyn (Ampicillin / Sulbactam)

Clindamycin versus Unasyn in the treatment of facial cellulitis of odontogenic origin in children. [2007.03]
The study was undertaken to characterize the microbiology of dental abscesses in children and to compare clindamycin and ampicillin/sulbactam in the treatment of facial cellulitis of odontogenic origin. Sixty children with acute facial cellulitis of dental origin underwent surgery (extraction or root canal procedure) within 24 hours of presentation...

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.

Peritonsillar abscess: a comparison of outpatient i.m. clindamycin and inpatient i.v. ampicillin/sulbactam following needle aspiration. [2005.06]
In an attempt to assess the effect of antibiotic choice on the treatment of peritonsillar abscess, we compared the clinical efficacy of empiric intramuscular clindamycin and intravenous ampicillin/sulbactam (following needle aspiration of the abscess) in a prospective, randomized study of 58 patients...

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Clinical Trials Related to Unasyn (Ampicillin / Sulbactam)

T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam [Recruiting]
The aim of the study was to compare the activity (efficacy and safety) of Ertapenem administered according to a short treatment for three days versus a short treatment for three days with AS in patients with an community acquired IAI of mild to moderate severity.

Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections [Recruiting]
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavutanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

Preoperative Antibiotics Study [Recruiting]
The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to

- decrease the incidence of surgical sight infections

- speed the progression of postoperative healing

- improve the final quality of wound healing achieved

- decrease the rate of palatal fistula formation

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.

Ampicillin-Sulbactam Resistant E.Coli at UPMC [Recruiting]
The information collected will optimize the management of patients with gram negative bacteremia. Approximately 300 patients with Gram negative bacteremia are cared for each year at UPMC-P. Published medical literature suggests that mortality from this infection exceeds 20%. The aim of this research is to determine the risk factors for bacteriologic failure of antibiotic therapy, risk factors for antibiotic resistance in bloodstream isolates and risk factors for mortality from Gram negative bacteremia. Modifiable risk factors can then be tackled by a future interventional study.

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